MOBILE MONITORING DEVICE AND METHOD FOR PREDICTING AND DETECTING POST-SURGICAL COMPLICATIONS - Patent application

Abstract

The monitoring device includes an input port attachable in fluid communication with a catheter, the catheter being inserted into a user's body to receive fluid from the user's body, an output port in fluid communication with a fluid reservoir and generally parallel to the input port, a fluid channel defining fluid communication between the input port and the output port, and a biosensor for continuously measuring biosignal data of the fluid in the fluid channel, the biosensor including an electrode pair, the biosensor in communication with a computing device for determining a user's condition based at least in part on the biosignal data.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 823,897, filed March 26, 2019, the contents of which are incorporated herein by reference.

[0002] The present disclosure relates to systems, methods, and devices for monitoring, predicting, and detecting various forms of post-operative complications. [Background technology]

[0003] Surgical procedures can use open and minimally invasive techniques on a user, such as a patient, to identify and treat pathological conditions or improve bodily function. Surgeries performed for a variety of reasons have an inherent risk of developing post-operative complications, such as bleeding, infection and leakage.

[0004] One of the most dangerous complications to surgery is that known as anastomotic leak. Anastomotic leaks can occur after an anastomosis is performed, where two organs are surgically connected, and are most commonly observed in gastrointestinal surgery. Anastomotic leaks can result in luminal contents leaking into the peritoneal cavity, setting off a cascade of potentially fatal complications. This typically involves forms of severe sepsis, peritonitis, morbidity, and can lead to death.

[0005] Using conventional techniques, it can take an average of three to seven days to diagnose a leak, which can be extremely dangerous, especially considering that with every passing second, the risk of patient morbidity and mortality increases considerably.

[0006] Typically, medical facilities wait for clinical factors such as abdominal pain, fever and tachycardia to occur before making a diagnosis. Existing techniques for detecting postoperative complications such as anastomotic leaks can be non-specific, inefficient, time-consuming, expensive and / or lack the ability to provide real-time detection of complications. Summary of the Invention

[0007] The incidence of leakage from surgical procedures can vary from 1% to 40% in some cases. The causes of the occurrence of anastomotic leakage are still being studied, and a definitive cause has yet to be identified. However, there are risk factors associated with a higher incidence, such as age, sex, organ tension, local ischemia, medical history, and surgical errors.

[0008] Physiological changes may occur prior to and during the onset of a leak, including tissue necrosis, most typically seen at the surgical site and also caused by local ischemia. Another change that may be seen is the collapse of the surgical site, which may be associated with staple line failure.

[0009] Leaks that can occur across different organs include gastric, fecal, urinary and bile leakage into the abdominal cavity, which are typically difficult to diagnose early. Other forms of luminal leakage include leakage of saliva or gastric contents in thoracic surgery. In addition to the different forms of luminal leakage that can occur, different forms of bleeding can occur after surgery.

[0010] Although imaging techniques such as computed tomography (CT) imaging can be used for leak detection, CT imaging has certain drawbacks, especially due to its low sensitivity, ionizing radiation, and the long time it takes to acquire and evaluate images. Such systems and techniques require hospital facilities and trained personnel from different specialized teams to operate these techniques. Furthermore, hospital facilities must be equipped with highly standardized equipment and timed reporting systems to ensure proper detection of these postoperative complications in a timely manner.

[0011] Other techniques that may reduce the likelihood of a leak occurring during surgery include imaging techniques designed to monitor the blood supply to the area. While such imaging techniques can reduce the risk of a leak in some cases, they cannot prevent future leaks from occurring.

[0012] Other methods for detecting postoperative complications such as leakage complications can include gas sensors (monitoring specific analytes such as CH4 and N2). However, most of these techniques suffer from significant drawbacks related to sensitivity, specificity, cost, and applicability in clinical settings.

[0013] The present disclosure provides systems, methods and devices for analyzing bodily and luminal fluids, including but not limited to ascites, peritoneal drainage, pleural drainage, gastric fluid, feces, bile fluid, urine, amniotic fluid, dialysate, sebum or blood. Fluids can be continuously monitored for changes and trends in specific analytes and biological properties. Examples of these properties and analytes include but are not limited to pH, lactate, electrolytes, impedance, conductivity, dissolved oxygen, dissolved CO2, temperature, inflammatory markers, enzymes, bacterial proteins, RNA or lipids. The systems, methods and devices disclosed herein can be used for a variety of diagnostic applications, such as, but not limited to, post-operative leaks, ischemia, infection, and sepsis.

[0014] In some embodiments, sensors such as biosensors can be placed on a catheter, which can be inserted into the body and can allow fluids to be infused or withdrawn from the body. The catheter can be placed proximal to a surgical site to monitor the environment of biological fluids proximate to the area. Fluids can be sensed locally directly without the need for negative pressure, or negative pressure can be used to assist in driving fluids through the catheter. Any number of sensors can be placed on the surface of the catheter to directly contact biological fluids surrounding an area of ​​interest, such as a suture line in the case of an anastomosis. Sensors may also be placed inside a catheter, a balloon, a pump, or any tube that can collect fluid.

[0015] In further embodiments, the sensor may be housed in a system that can be placed in-line with a catheter. The catheter may be placed proximal to the surgical site to monitor the ascites environment proximate the area. The system may be an extension of an existing catheter system. The system may be attached at the time the catheter is in place or at any time at a later date.

[0016] Conveniently, early management to treat complications and address leaks using the techniques disclosed herein may significantly reduce the risks associated with such complications.

[0017] Existing techniques for addressing complications may include using interventional radiology techniques to address existing complications in patients. In the case of leaks, this may include techniques such as placing in drains, placing stents, forcing staple line sutures, etc. These interventions may be performed endoscopically without the need to perform a second surgery. Using the systems and techniques disclosed herein to monitor the user's status may allow for more effective treatment plans and earlier intervention if a complication reappears.

[0018] Additionally, the technology disclosed herein can enable at-home monitoring of post-operative progression as more patients move outside of patient monitoring settings. Additionally, the technology disclosed herein can enable users to continuously monitor the status of a patient procedure, which can be an improvement over existing diagnostic tests that take samples at specific time points that may not be indicative of the patient's status.

[0019] According to one aspect, a monitoring device is provided comprising: an input port attachable to be in fluid communication with a catheter, the catheter being inserted into a user's body to receive fluid from the user's body; an output port generally parallel to the input port and in fluid communication with a fluid reservoir; a fluid channel defining fluid communication between the input port and the output port; and a biosensor in communication with a computing device for continuously measuring biosignal data of fluid in the fluid channel, the biosensor including an electrode pair.

[0020] In some embodiments the computing device is for determining a state of a user based at least in part on the biosignal data.

[0021] In some embodiments, the biosensor includes an impedance sensor for detecting the conductivity of a fluid in the fluid channel.

[0022] In some embodiments, the biosensor includes a pH sensor for detecting the pH level in the fluid in the fluid channel.

[0023] In some embodiments, the biosensor includes at least one of a lactate sensor, an amylase sensor, a urea sensor, or a creatinine sensor.

[0024] In some embodiments, the device further comprises a flow sensor for continuously determining the flow rate of the fluid in the fluid channel over time.

[0025] In some embodiments, the device further comprises a light-based sensor including an optical transmitter and an optical receiver for detecting the transmission of light through the fluid in the fluid channel.

[0026] In some embodiments, the light-based sensor is configured to detect a color of the fluid based at least in part on the detected wavelength.

[0027] In some embodiments, the device further comprises a temperature sensor for detecting the temperature of the fluid in the fluid channel.

[0028] In some embodiments, the biosensor is disposed on a substrate in fluid communication with the fluid channel.

[0029] In some embodiments, the electrode pairs are arranged sequentially along the length of the fluid channel.

[0030] According to another aspect, a computer-implemented method for monitoring a user is provided, the method including continuously receiving biosignal data from a biosensor in fluid communication with a fluid; determining a condition of the user based at least in part on the biosignal data; and predicting a future occurrence of a complication based at least in part on the condition of the user.

[0031] In some embodiments, the method further includes receiving a user profile, the user profile including information related to surgical procedures performed on the user, and a future occurrence of a complication is predicted based at least in part on the user profile.

[0032] In some embodiments, the method further comprises updating a profile of the user based at least in part on the biosignal data.

[0033] In some embodiments, the method further includes continuously receiving flow data from a flow sensor in fluid communication with the fluid from the user's body, and determining a flow rate of the fluid based at least in part on the flow data, wherein the user's condition is determined based at least in part on the flow rate.

[0034] In some embodiments, the method further includes determining a change in flow rate of the fluid over time and a change in the vital sign data over time, and predicting a future occurrence is based at least in part on the change in flow rate and the change in the vital sign data.

[0035] In some embodiments, the flow data is received in near real-time.

[0036] In some embodiments, the biosignal data is received in near real-time.

[0037] In some embodiments, the method further includes receiving optical data related to the transmission of light through the fluid from a light-based sensor in fluid communication with the fluid.

[0038] In some embodiments, the method further comprises determining a color of the fluid based at least in part on the light data.

[0039] In some embodiments, the method further includes receiving temperature data of the fluid from a temperature sensor in fluid communication with the fluid.

[0040] In some embodiments, the method further comprises modulating the biosignal data based at least in part on the temperature data.

[0041] In some embodiments, the method further comprises determining the user's risk factor based on cross-correlation with trends in the biosignal data of other users.

[0042] In some embodiments, the user's condition is based at least in part on determining whether the vital sign data is within a threshold range.

[0043] According to a further aspect, there is provided a system for monitoring a user comprising a processor and a memory in communication with the processor storing instructions that, when executed by the processor, cause the processor to perform a method as described herein.

[0044] Other features will become apparent from the following description taken in conjunction with the drawings. [Brief description of the drawings]

[0045] [Figure 1] FIG. 1 is a diagram of a system utilized to detect surgical leaks, including a sensor device having a catheter embedded with a biosensor in proximity to a surgical site and with data visualized on a remote device, according to one embodiment. [Figure 2A] FIG. 1 is a close-up view of a biosensor integrated onto a catheter of a sensor device, according to one embodiment. [Figure 2B] FIG. 13 is a close-up view of a biosensor integrated onto a catheter of the sensor device according to another embodiment. [Figure 2C] FIG. 13 is a close-up view of a biosensor integrated onto a catheter of a sensor device according to yet another embodiment. [Figure 3A] FIG. 1 is a close-up view of a biosensor incorporated inside a catheter lumen of a sensor device, according to one embodiment. [Figure 3B] FIG. 13 is a close-up view of a biosensor incorporated inside a catheter lumen of a sensor apparatus according to another embodiment. [Figure 3C] FIG. 13 is a close-up view of a biosensor incorporated within a catheter lumen of a sensor device according to yet another embodiment. [Figure 4A] FIG. 1 is a close-up view of the catheter lumens and fluid and wire configuration of the sensor apparatus, according to one embodiment. [Figure 4B] FIG. 13 is a close-up view of the catheter lumens and fluid and wire configuration of the sensor apparatus according to another embodiment. [Figure 4C]FIG. 13 is a close-up view of the catheter lumens and fluid and wire configuration of the sensor apparatus according to yet another embodiment. [Figure 4D] FIG. 13 is a close-up view of the catheter lumens and fluid and wire configuration of the sensor apparatus according to yet another embodiment. [Figure 5A] FIG. 1 illustrates a system configuration including a sensor device placed in the abdomen for diagnostic applications in gastrointestinal (GI) surgery, according to one embodiment. [Figure 5B] FIG. 1 illustrates a system configuration including a sensor device placed in the abdomen for diagnostic applications in gastrointestinal (GI) surgery, according to another embodiment. [Figure 5C] FIG. 13 illustrates a system configuration including a sensor device placed in the abdomen for diagnostic applications in gastrointestinal (GI) surgery, according to yet another embodiment. [Figure 5D] 1 is a schematic diagram of a system including a sensor device, according to one embodiment. [Figure 5E] FIG. 5E illustrates a configuration of the system of FIG. 5D with the sensor device positioned in the pleural cavity adjacent the chest, according to one embodiment. [Figure 5F] FIG. 1 illustrates a system including multiple sensor devices, according to one embodiment. [Figure 5G] FIG. 5E is a front view of the sensor device of FIG. 5D. [Figure 5H] FIG. 5E is a side perspective view of the sensor device of FIG. 5D. [Figure 5I] FIG. 5E is a top perspective view of the sensor device of FIG. 5D. [Figure 6A] FIG. 1 illustrates a close-up view of a biosensor of a sensor device that can be wirelessly connected to an external receiver, according to one embodiment. [Figure 6B] FIG. 13 is a close-up view of a biosensor of a sensor device that can be wirelessly connected to an external receiver, according to another embodiment. [Figure 7] FIG. 1 illustrates an exemplary system design that can be utilized to collect signals from a biosensor and relay them to a user. [Figure 8]1 is a process flow diagram illustrating a system for detecting anastomotic leakage, according to one embodiment. [Figure 9] 1 is a graph illustrating the form of a readout that can be obtained from a data collection system, according to one embodiment. [Figure 10] 2 is a block diagram of exemplary hardware components of a computing device of the system of FIG. 1 according to one embodiment. [Figure 11] FIG. 11 illustrates a software configuration for the computing device of FIG. 10 in accordance with one embodiment. [Figure 12A] 12 is a flowchart of a method for detecting or predicting leaks performed by the software of FIG. 11 according to one embodiment. [Figure 12B] 12 is a flowchart of a method for monitoring a user performed by the software of FIG. 11 according to one embodiment. [Figure 13] FIG. 1 shows a table of reported GI tract pH values ​​in humans. [Figure 15A] FIG. 1 illustrates sensor data captured during the study. [Figure 15B] FIG. 15B shows details of the study in FIG. 15A. [Figure 16A] FIG. 2 is a perspective view of a sensor assembly of an in-line monitoring device, according to one embodiment. [Figure 16B] FIG. 16B is a cross-sectional view of the sensor assembly of FIG. 16A taken along line II. [Figure 16C] FIG. 16B is a cross-sectional view of the sensor assembly of FIG. 16A along line II with particles suspended in the fluid channel. [Figure 17A] FIG. 1 is a perspective view of a sensor assembly including light-based sensors disposed on two substrates, according to one embodiment. [Figure 17B] FIG. 17B is a cross-sectional view of the sensor assembly of FIG. 17A taken along line II-II. [Figure 18A] FIG. 1 is a perspective view of a sensor assembly having a fiber optic light-based sensor according to one embodiment. [Figure 18B]FIG. 18B is a cross-sectional view of the sensor assembly of FIG. 18A taken along line III-III. [Figure 19A] FIG. 1 is a perspective view of a sensor assembly having a light-based sensor, according to one embodiment. [Figure 19B] FIG. 19B is a cross-sectional view of the sensor assembly of FIG. 19A taken along line IV-IV. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] The systems, methods, and devices disclosed herein may be utilized to monitor, detect, and predict various forms of post-operative complications, such as leaks, that may occur following surgery. Embodiments may include sensing and diagnostic devices that utilize, for example, sensors on a catheter or in-line device to detect or predict the presence of luminal fluid, for example, when a leak occurs.

[0047] In some embodiments, the systems, methods, and devices disclosed herein include a sensor, such as a biosensor, that can be used to sense biosignal data placed in proximity to the surgical site, allowing monitoring of biofluids for analytes that may be indicative of a surgical leak.

[0048] In some embodiments, the sensor may include electrochemical or solid state sensors with different morphologies including, but not limited to, potentiometric, voltage measuring, conductivity measuring, capacitance measuring, amperometric or ion sensitive field effect transistors (ISFETs). In some embodiments, the sensor may be a piezoelectric system or a microelectromechanical system (MEMS). The sensor may include terminals that connect to an active electrode, a counter electrode, a reference electrode or a pseudo reference electrode depending on the type of sensor being utilized. The sensor may be of various types including, but not limited to, pH sensors, ion sensitive sensors, temperature sensors, lactate sensors, electrolyte sensors, impedance sensors, fluid sensors, optical based sensors, microbial sensors, protein sensors, inflammation sensors, carbohydrate sensors, enzyme sensors, oxygen sensors such as PO2 (oxygen partial pressure) sensors, amylase sensors, urea sensors, creatinine sensors, pressure sensors and flow sensors.

[0049] The sensors may be connected in series or parallel, for example positioned sequentially along the length of a fluid channel.

[0050] In some embodiments, the sensor may include a temperature sensor, such as a thermistor.

[0051] During use, a thermistor can undergo a change in resistance that correlates to a change in temperature, and therefore the temperature can be determined by determining the resistance of the thermistor by exciting it with a current and measuring the voltage, or vice versa.

[0052] Temperature sensors can be used to account for numerous artifacts and sources of error in biosignal measurements. Temperature sensors can be used to compensate or modulate signals from other sensors that are temperature dependent, such as impedance and pH. Because biological fluids tend to have a higher temperature relative to the ambient temperature, an increase in fluid temperature detected by a temperature sensor can indicate the influx of new fluid.

[0053] An array of temperature sensors and heating elements can be used to measure fluid flow using the principles of thermal mass fluid transport.

[0054] In some embodiments, the sensor may include a flow sensor, such as a flow meter, for measuring the volumetric or mass flow rate of a fluid, such as a liquid or gas, within the user's body.

[0055] In some embodiments, the sensor may include an essentially electrochemical pH sensor that allows for the conversion of biological analytes into electrical signals that can be measured, monitored and analyzed to determine if post-operative complications are occurring. A system of interdigitated electrodes (active, counter and reference) may be fabricated on a biocompatible substrate. The electrodes may be manufactured from biocompatible materials: gold, platinum, titanium and silver, and then later functionalized with activated polyaniline (PANI) polyaniline / polyurethane (PAIN / PU), polyurethane, polymer or other suitable layers. In one example, the μ-biosensors are 500 μm x 500 μm in size, allowing them to be placed on catheters to monitor pH changes over time.

[0056] The pH sensor may be formed from a conductive polymer made from an aniline monomer. The sensitivity of a suitable conductive polymer to pH levels may enable its use as the pH-sensitive component in a pH sensor.

[0057] A pH sensor may be calibrated and / or controlled by a potentiostat, specifically an electronic device that controls the potential and current difference of a three-electrode system that includes a working electrode (WE), a reference electrode (RE) and a counter electrode (CE). This electrical device has many applications that may be used to make a pH sensor, such as cyclic voltammetry (CV), chronoamperometry and chronopotentiometry.

[0058] The pH sensor may be configured to detect a pH value within a threshold or boundary, or a deviation from such a boundary.

[0059] In some embodiments, the sensor may include an optically based sensor, such as a photoelectric sensor, that utilizes an optical transmitter or light source and detector combination in the ultraviolet to infrared spectrum to measure the optical absorption or transmission properties of the fluid. Single or multiple wavelengths of light may be used.

[0060] Optical-based sensors include a combination of optical transmitters and detectors in the ultraviolet to infrared spectrum and can be used to measure the optical absorption or transmission properties of a fluid.

[0061] The light absorption or transmission properties can indicate changes in bodily and luminal fluids, which may include, but are not limited to, protein composition and concentration, pH, conductivity, inflammatory markers, and cellular activity due to the onset of a complication or disease. This also allows for the measurement of the color of bodily fluids, which can indicate bleeding (red), bile leakage (green-yellow), fecal leakage (brown), gastric leakage (green), urinary leakage (yellow), and other bodily fluids of a particular color.

[0062] In some embodiments, single or multiple wavelengths of light can be used. Detection of changes in the absorption or transmission properties of the fluid within a particular light band or wavelength can allow for a measurement of the color of the fluid. Since serous fluids (e.g., peritoneal and pleural fluids) are typically light yellow, a color change can indicate bleeding (red), bile leakage (green-yellow), fecal leakage (brown), gastric leakage (green), urinary leakage (yellow), or other fluids of a particular color.

[0063] In some embodiments, the light-based sensor can include a combination of light transmitters and detectors in the ultraviolet to infrared spectrum to measure the scattering of light by the fluid to measure its turbidity. Serous fluids are typically clear in appearance and have little cloudiness. For example, an increase in turbidity measured as an increase in light measured by a photodetector at an orthogonal angle can indicate white blood cells and microorganisms in the fluid that may result from an infection.

[0064] Light-based sensors can include multiple light sources and receivers. For example, a single broadband light source can be used in combination with multiple band-specific photodiodes (e.g., red, green, and blue). In this way, the absorption / transmission properties of the fluid can be measured over as many bands as there are photodetectors. Similarly, multiple light sources can be utilized in combination with a single broadband photodetector, whereby each light source is turned on sequentially and the transmitted light is measured by the photodetector accordingly. Finally, light sources and photodetectors can also utilize dynamic filters to allow emission or detection of specific light bands instead of multiple light sources or photodetectors.

[0065] In some embodiments, the sensor includes an impedance sensor that normally operates with alternating current (AC) excitation that can be used to assess a user status. The impedance sensor can include an electrode pair and can include excitation and readout circuitry.

[0066] In some embodiments, the impedance sensor can be configured to perform AC excitation within a well-defined, constant fluid geometry (constrained by a channel or housing) and can determine normalized impedance (or specific impedance) and admittance.

[0067] In some embodiments, the impedance of the fluid can be measured over a range of frequencies (Hz-MHz range) to separate the contributions of individual electrolytes and infer the ionic composition of the fluid. The user state may be based at least in part on the ionic composition of the fluid.

[0068] The measured impedance values ​​can be converted to determine the conductivity of the fluid (e.g., the real component of the impedance). The conductivity can reveal properties of the fluid itself and therefore can provide direct clinical value. For example, the conductivity can indicate the inherent properties and composition of an analyte.

[0069] Impedance can be affected by the volume and geometry of the fluid, and therefore the measured impedance can be used to localize and track particles and bubbles within fluid channels.

[0070] In some embodiments, impedance sensors can be used to account for numerous artifacts and sources of error in biosignal measurements.

[0071] In some embodiments, an impedance sensor can be used to detect a rapid and dramatic increase in impedance over a range of bodily fluids that may indicate the presence of air bubbles in the channel. Air bubbles are a challenge for catheter-based measurements because they cause artifacts in the readings.

[0072] In some embodiments, an impedance sensor can be used to detect sudden increases in impedance, which can indicate the presence and amount of non-homogeneous materials and particles (e.g., thrombus, fibrin).

[0073] In some embodiments, the impedance sensor can be used to detect blood clotting (typically characterized by a sudden increase in impedance followed by a slower but sustained increase in impedance) and therefore the presence of blood and the risk of channel blockage.

[0074] In some embodiments, using an array of impedance sensors positioned along a channel, the techniques described herein can be used to detect and track bubbles, non-homogeneous materials, and / or particles as they pass through the channel.

[0075] In some embodiments, the sensor may include an amylase sensor.

[0076] In use, the systems, methods and devices may monitor trends and changes in physical and chemical biomarkers, which may include, but are not limited to, pH, temperature, fluid flow, pressure, lactate, lactate, nitrate, glucose, alkali ions, oxygen, bicarbonate, inflammatory proteins, bacterial proteins, and other biomarkers associated with or correlated with a leak, for example.

[0077] A single sensor or an array of sensors may be placed along the wall of the catheter, in a dedicated lumen, or in an in-line device, allowing the device to detect and monitor if a leak is occurring.

[0078] In some embodiments, the catheter may be used as a carrier for sensors to monitor internal compartments of the body, such as the peritoneal or pleural cavities, without applying negative pressure. The catheter may be connected to a balloon or mechanical pump to apply negative pressure to facilitate drainage of fluids. The catheter may also be connected to a fluid source, such as saline, to perform therapeutic and diagnostic functions, such as dialysis or irrigation.

[0079] In some embodiments, multiple sensors may be spaced along the length of the catheter. Multiple sensors positioned along the catheter may sense multiple regions, allowing the spatial progression of the leak to be tracked.

[0080] The catheter may have a hollow or solid body and may be formed from a tube made of a medical grade material, such as a suitable polymer, hi some embodiments, the catheter may be a flexible substrate.

[0081] In some embodiments, the catheter may be formed from a low friction material.

[0082] The catheters may have different designs; they may be cylindrical, rectangular, flat, or T-shaped in cross-section; they may have a single lumen or multiple lumens.

[0083] In some embodiments, the sensor may be placed in a reservoir where fluid may be collected from the user's body. The reservoir may include elements such as a balloon, pump, or other container that may hold biological fluid. The sensor placed in the reservoir may be used simultaneously with the sensor placed in the catheter. This may allow for more sensors to be utilized to determine a variety of different conditions or post-operative complications, such as fluid leakage, infection, inflammation, or other dangerous complications.

[0084] The sensor, such as the biosensor, may be connected to a monitor, such as an electronic data acquisition system (DAQ), which may be located inside or outside the user's body, that can continuously process the data obtained from the sensor. The connection may be established by different methods, including but not limited to wires and connectors that may be embedded within the body of the catheter or within at least one lumen designed to allow the wires and connectors to pass through them. The connection may also be established wirelessly, by transmitting data obtained in vivo from the biosensor through a transmission system to a receiver located outside the body.

[0085] In some embodiments, each of the multiple sensors is in independent communication with the monitor.

[0086] The monitor may have a screen that allows the readout to be observed directly on the device. The monitor may also use various visual or audio cues, such as small LEDs or alarm sounds, to notify of various events.

[0087] The data acquired by the monitor can also be communicated via wired or wireless media to a computer system to allow for further analysis and visualization. The communicated data may be processed and may be raw or summarized.

[0088] In some embodiments, the data collected by the monitor can be analyzed to identify trends associated with the development of different complications. This can be done by evaluating single or multiple data sets obtained over time from one or more sensors to diagnose and determine the stage of development of a complication.

[0089] If one or more sensors indicate a biological trend associated with a surgical leak, an alarm signal is sent from the monitor to a computer-based system, allowing the user to determine appropriate medical action.

[0090] In one example, a slow drop in local pH may indicate either a small leak or insufficient blood supply to the wound site. If a concomitant slow increase in lactate concentration is observed, it may indicate a lack of blood supply (i.e., ischemia). If the lactate concentration remains stable, it may indicate a slow leak.

[0091] In another example, a sudden drop in pH may indicate a large leak. If the pH returns to its baseline, it may suggest that the wound is healing despite the leak. If the pH continues to drop or remains low, it may indicate a significant leak that the body may have difficulty recovering from.

[0092] The systems and methods disclosed herein can perform monitoring, detection and diagnosis, as well as prediction. For example, monitoring can present data sensed by a sensor, such as a biosensor. Detection and diagnosis can detect the user's condition and / or determine a diagnosis, such as a leak, what kind of leak it is, and where the leak came from, by an algorithm, for example, with an associated confidence level. Prediction can use sensory data to look for different trends and process signals to predict possible leaks that may occur in the future, for example, with an associated confidence level. Thus, embodiments of the systems and methods disclosed herein can identify physiological differences between occurring leaks and precursors to leaks.

[0093] The systems and methods disclosed herein may be used to perform clinical functions. In one example, a catheter system, in addition to its diagnostic function, may be connected to a mechanical element capable of applying negative pressure to allow fluid to be drained from the user's body. Both such clinical functions may be performed within a location within the user's body, such as in the GI tract or the peritoneal cavity.

[0094] Techniques for applying negative pressure can include, but are not limited to, balloons, mechanical pumps, vacuum systems, or other devices that can, for example, draw fluid out of the body. In some embodiments, the fluid being evacuated can assist in diagnostic applications by causing a constant fluid flow across a sensor. In some embodiments, clinical functions may be performed by pumping fluid into the user's body.

[0095] The term "body fluids" as used herein may refer to fluids originating from within the human body, fluids excreted or secreted by the body (e.g., blood, gastric juices, and peritoneal fluids), and similar fluids. By extension, the term "luminal fluids" refers to a subset of body fluids present within the lumen, intestines, blood vessels, tubular organs, and many other membrane-bound organs, such as gastric juices, intestinal juices, feces, urine, bile, and other similar fluids.

[0096] The terms "biomarker" and "aptamer" as used herein may refer to molecules, substances, and chemical or physical properties that can be measured or detected as biological signals in bodily fluids, including, but not limited to, pH, temperature, electrolyte concentrations, fluid flow rates, pressure, lactate, lactate, nitrate, alkali ions, inflammatory proteins, bacterial proteins, specific cells, molecules, genes, gene products, enzymes, hormones, inflammatory proteins, and glucose.

[0097] The terms "biosensor" and "sensor" as used herein may refer to devices or systems that detect or respond to biomarkers or biological signals and convert these signals into measurable electrical signals. Biosensors and sensors utilized herein may include, but are not limited to, pH sensors, lactate sensors, amylase sensors, lactate sensors, glucose sensors, temperature sensors, pressure sensors, enzyme sensors, protein sensors, biological sensors, ion sensors, electrolyte sensors, impedance sensors, conductivity sensors, flow sensors, and other forms of electrochemical and solid-state sensors.

[0098] 1 is a schematic diagram of a system 100 for predicting or detecting post-operative complications, such as anastomotic leakage, in a user, according to one embodiment. The system 100 includes a sensor device 101 for sensing fluid and has a catheter 104 with a sensor 106 attached. The system 100 also includes a monitor, such as a data acquisition (DAQ) system 102, and an external computing device 112 that can be connected to the DAQ 102 via a network 140.

[0099] The system 100 can allow a user or patient to be monitored for signs of post-operative leakage, for example in a medical facility, by placing the external monitor 102 within the facility. Also, according to this embodiment, the system 100 can allow a user to leave the facility with the mobile monitor 102 by attaching the monitor to the user's body. The system 100 can alarm the user or other individuals using visual and audio signals if a post-operative or surgical complication is detected.

[0100] The system 100 may include a sensor device 101 having a catheter 104 and a sensor 106 disposed within a user's body, with all other components of the system 100 being external to the user at a local or remote location. Thus, less size, power, and functionality may be present at the sensing end of the sensor device 101, which may reduce the effects of foreign object intrusion into the user's body, and may also reduce mechanical stress on the sensor device 101 due to its lighter weight.

[0101] In some embodiments, the sensor device 101 may enter the body through the incision 116 and be placed inside the abdominal cavity 122 of the user.

[0102] Additionally, the sensor device 101 may be designed to be disposable and cheaper components may be used.

[0103] Catheter 104 may be an embodiment of the catheters described herein.

[0104] The sensors 106 may include, for example, sensors and biosensors used to detect chemicals in or from the body of a user, as described herein. As such, the sensors 106 may be sized in an appropriately small configuration.

[0105] In some embodiments, the sensor 106 may include a flow meter, for example to measure the volumetric or mass flow rate of a liquid or gas into or out of the user's body, as described herein.

[0106] In some embodiments, the sensor 106 may include a pH sensor for measuring the pH of fluids in or from the user's body, as described herein.

[0107] In some embodiments, the sensor 106 may be located on the catheter 104. In some embodiments, the sensor 106 may be located on a module attached to the end of the catheter 104.

[0108] The sensor 106 can monitor biological fluids surrounding the staple line, such as ascites fluid naturally present in the area. If an obstruction occurs along the staple line 118, the sensor 106 can convert a signal that can be collected using a data acquisition (DAQ) system 102 located outside the user's body.

[0109] The DAQ 102 can read a signal indicating that a leak has occurred and can relay a visual signal 110 and / or an audio signal.

[0110] The DAQ 102 may transmit the signal 108, for example, as a wireless signal or over a network 140 to an external computing device 112 where the biosignal may be further processed and displayed to a user 114. The network 140 may be a packet-switched network in the form of, for example, a LAN, a WAN, the public Internet, a Virtual Private Network (VPN), etc.

[0111] 1, the system 100 may also include an external computing device 112. In some embodiments, the external computing device 112 may be located outside the healthcare institution and may enable remote monitoring of the sensor device 101.

[0112] In some embodiments, the external computing device 112 may be associated with a remote healthcare or medical professional, such as a nurse, who may be making an outpatient on-site visit to a user. Based on data in signals 108, for example received from the DAQ 102 and associated with one or more users, each having a sensor device 101, the remote healthcare professional can be alerted with a triage of which users should visit first, based on an order of urgency of data regarding the monitored status of the users.

[0113] 2A-2C illustrate different shapes and forms of sensors 220 that may be utilized over the surface of catheter 202 of sensor devices 201A, 201B, 201C, respectively. Sensors 220 may include sensors and biosensors as described herein. Sensors 220 may take different forms and perform different functions than those illustrated herein. In some embodiments, sensors 220 may be electrochemical, electromechanical, or solid in nature.

[0114] 2A-2C show that the sensor 220 may be embedded in the outer wall of the catheter 202. The sensor 220 may be disposed on the flexible substrate 216 or may be embedded on the body of the catheter 202. Also, according to this embodiment, a system is shown that allows for the utilization of an array of sensors 220.

[0115] The sensor 220 is shown connected via two leads 210, 212 for a sensor 220 having two terminals, or three leads 228, 230, 232 for a sensor 220 having three terminals.

[0116] The sensor 220 may be an electrochemical-based sensor and may have terminals that connect to an active electrode, a counter electrode, a reference electrode, or a pseudo-reference electrode depending on the type of sensor utilized. The sensor 220 may be a potentiometric, voltammetric, conductometric, capacitive, or amperometric sensor. The sensor 220 may also be a solid-state sensor such as a field effect transistor (FET) or a piezoelectric biosensor. Wire leads may be threaded through holes or perforations 206, 208 into a dedicated lumen 240 and exposed to the sensor on the catheter surface. The catheter 202 may also have holes or perforations 204 that allow for fluid flow into the catheter 202.

[0117] FIG. 2A shows, in one embodiment, a sensor device 201A having a sensor 220 that includes a system of interdigitated electrodes 214, 218 that can be used for electrochemical sensing.

[0118] In another embodiment, FIG. 2B shows a sensor device 201B having an active sensing component disposed on a surface of a conductor 226 embodied as a sensor 220, along with a reference electrode 222 and a counter electrode 224 to enable biosensing of chemical and physical constituents.

[0119] In another embodiment, FIG. 2C shows another configuration of a sensor device 201C including a sensor 220 having a three-electrode based system utilized for biosensing of a biomarker, where electrodes 234, 236, 238 can function as active, counter, reference and pseudo reference electrodes and are connected via leads 228, 230, 238.

[0120] 3A-3C show different shapes and configurations of an array of sensors 320 that may be utilized inside a dedicated lumen of a catheter 302 of a sensor device 301A, 301B, 301C. The sensors 320 may include sensors and biosensors described herein.

[0121] In some embodiments, the sensor 320 is disposed within a dedicated lumen in the catheter 302. The catheter 302 can have openings or perforations 304 that allow biological fluids to contact the sensor 320 inside the dedicated lumen. The active surface of the sensor 320 (i.e., where the sensor active components are located) may be positioned to contact fluids flowing through the dedicated lumen for other clinical purposes.

[0122] The terminals of the sensor 320 may be connected to an active electrode, a counter electrode, a reference electrode, or a pseudo-reference electrode, depending on the type of sensor being utilized. For electrochemical-based sensing, the sensor 320 may be a potentiometric, voltammetric, conductometric, capacitive, or amperometric sensor. The sensor 320 may also be a solid-state sensor, such as a field effect transistor (FET)-based biosensor.

[0123] Wire 340 connects to sensor 320 and may be located in a dedicated lumen or may run through the same lumen in which sensor 320 is active from the inside.

[0124] FIG. 3A illustrates a sensor device 301A that includes a sensor 320 having a system of interdigitated electrodes 314, 318 that can be used for electrochemical sensing, in one embodiment.

[0125] In another embodiment, FIG. 3B shows a sensor device 301B having an active sensing component such as a sensor 320 disposed on a surface of a conductor 326 to enable biosensing of chemical and physical constituents using, in one embodiment, a reference electrode 322 and a counter electrode 324.

[0126] In another embodiment, Figure 3C shows a sensor device 301C including a sensor 320 having a three-electrode based system that, in one embodiment, can also be utilized for biosensing of chemical and physical components. Electrodes 334, 336, 338 can act as electrochemical electrodes (active, counter and reference).

[0127] 2A-2C and 3A-3C show different forms of sensing setups for the sensor device where multiple sensors can be placed across the catheter, allowing the catheter to actively sense biological fluids in its environment. Fluids can be sensed by having sensors embedded in the catheter surface to allow sensing of biological fluids around the catheter. Sensing can be independent of other functions the catheter may be performing, such as draining fluid from the body or pumping it into the body. Biological fluids can also be sensed by allowing fluid to flow into the catheter through multiple perforations on the catheter, such as perforations 304 as shown in FIG. 3. Sensors may be placed in dedicated lumens in the catheter that only house the sensors and their leads without performing other clinical functions. Sensors in these lumens may be placed in contact with biological fluids from around the catheter or from what flows within the catheter. The sensor configurations shown in FIGS. 2A-2C and 3A-3C show various examples of sensor configurations. In some embodiments, the sensors can have different configurations including more or fewer leads, different configurations, and different form factors.

[0128] In the configurations shown in Figures 2A-2C and 3A-3C, the sensors are connected in parallel and every terminal has a dedicated wire. Thus, each of the multiple sensors can communicate independently with a processor, such as a monitor or computer system as described herein. The sensor array may also allow for mapping of different analytes across the catheter 202, 302.

[0129] In some embodiments, sensor devices such as sensor devices 201A, 201B, 201C, 301A, 301B, 301C may be configured such that multiple terminals performing the same function are connected in parallel and share the same wire within the lumen. As an example, all active electrodes may be connected across the body of a catheter such as catheter 202, 302. This catheter design may also allow a user to cut catheter 202, 302 to shorten its length without interfering with the functionality (clinical or diagnostic) of the sensor device.

[0130] As will be appreciated, utilizing sensors on catheters as described herein may allow for multiple sensors to be positioned along the body of the catheter, and thus, different sensors may be used on a single sensor device, allowing for the analysis of one or more analytes or elements.

[0131] 4A-4D show examples of different catheter configurations that can be utilized to enable clinical and diagnostic applications of the sensor devices of systems 450, 460, 470, and 480, respectively. Systems 450, 460, 470, and 480 can include the sensors and biosensors described herein.

[0132] FIG. 4A shows, in one embodiment, a catheter 402 having a dual lumen system 450 that allows one of the lumens 406 to be dedicated to wires 410 and their connectors, while the second lumen 404 can be utilized to allow for drainage or pumping of fluids, for example, to perform a clinical function.

[0133] Figure 4B shows a dual lumen system 460 similar to Figure 4A in one embodiment, however, in this case the lumen utilized for the wire 416 may also be used to allow for fluid flow 414 across the catheter 412 and thus is not dedicated to electrical connections 420.

[0134] 4C shows, in one embodiment, a dual lumen system 470 having a conductor 430 embedded inside the wall of the catheter 422, allowing two lumens 424 to be used for fluid flow. The conductor 430 may be a wire embedded directly inside the catheter wall 426, or the wall of the catheter itself may be fabricated from a conductive material.

[0135] 4D shows a system similar to FIG. 4C, but constructed with three or more lumens 436, in one embodiment. Specifically, a three-lumen catheter system is used 480, where one of the lumens 436 is utilized to allow a wire 440 to pass therethrough, and the other two lumens of the catheter 432 may be utilized for fluid flow 434. In the illustrated example, the catheter 432 has a tubular form factor. However, it is understood that the form factor of the catheter 432 may also be flat, rectangular, tubular, or any combination thereof across the body of the catheter 432. For example, the catheter 432 may have a tubular design at the proximal end of the catheter 432 and a flat design at the distal end of the catheter 432.

[0136] The examples shown in Figures 4A-4D show specific examples that may be utilized. Catheters may be utilized with a wide variety of other lumen configurations. The lumens may be designed to allow only wires and connectors to pass through the lumen, or to allow only fluid to flow through the lumen, or to allow both wires and fluid to be present in the same lumen.

[0137] In some embodiments, multiple lumens can be utilized to calibrate the sensor being used across the catheter. Calibration can be performed by pumping different fluids into the catheter, allowing the sensor to be calibrated even when the device is inserted. The fluid inserted can be a specialized fluid that contains a controlled and specified amount of one or more biomarkers to allow the biosensor to calibrate. The fluid can also be a pH buffer or standard medical solution typically utilized in clinical settings, such as saline.

[0138] In some embodiments, calibration involves providing a known fluid in contact with the sensor to reset the baseline of its output. Housing sensors on a catheter, such as a catheter, can allow for the injection of calibration fluid, recording of the sensor output, and then the fluid being ejected.

[0139] 5A-5C show examples of systems 500, 550, and 580, respectively, in abdominal surgery, such as gastrointestinal (GI) surgery. Systems 500, 550, and 580 can include sensors, catheters, and monitors as described herein.

[0140] FIG. 5A illustrates the use of a sensor device 501 that, in one embodiment, can place a catheter 508 post-laparoscopically through a trocar incision 506. The sensor device 501 can be placed at different locations within the abdominal cavity 502, such as the paracolic groove, pelvis, adjacent to the staple line, or anywhere else within the cavity. Diagnostic techniques can rely on a sensor 504 in contact with a fluid, such as ascites, that is naturally present in the peritoneal cavity. Due to the biological properties of the fluid, many of the biomarkers can be assessed from different locations in the ascites and peritoneal cavity. Additionally, there is a constant flow of fluid across the peritoneal cavity as well as exchange of biomarkers and substances.

[0141] The system 500 shown as an example in FIG. 5A can detect different forms of surgical leakage that may occur in the abdominal cavity 502. As an example, a catheter 508 with a sensor 504 may be placed after laparoscopic abdominal surgery. If a surgical leakage occurs or shows signs of occurring, biomarkers associated with the leakage may mix with the peritoneal fluid, which can then be detected by the sensor. Further to this example, if a gastric leakage (anastomotic leakage) occurs due to necrosis along the staple line from bariatric surgery, the peritoneal fluid can be probed for biomarkers such as lactate, lactate, glucose, inflammatory markers, temperature or pH to diagnose the necrosis. When leakage begins, stomach contents may mix with the peritoneal fluid. The peritoneal fluid can then be probed for a number of biomarkers and substances, such as lactate, lactate, glucose, digestive enzymes, food components, inflammatory markers, etc., to determine if a leakage is present. If the monitor 510 records signals and trends associated with any of these complications, an alarm signal may be transmitted via means such as a light, sound, cellular message, Wi-Fi signal, or other communication channel. The alarm can then be communicated simultaneously to the patient (user), surgeon, caregiver, or other interested parties.

[0142] System 550 shown as an example in Figure 5B illustrates the use of system 550 in a gastroenterology application. As shown in Figure 5B, a catheter 528 can be placed through orifice 526 to monitor the gastrointestinal tract and detect different forms of surgical leaks or digestive disorders. Thus, system 550 is not placed inside peritoneal cavity 522 and therefore the fluids analyzed are different in this application.

[0143] Also according to this embodiment, FIG. 5B shows an example where an anastomosis 532 has been performed and post-operative monitoring of the patient is performed by a sensor 524 placed in a catheter 528 to determine if a leak has occurred. The sensor 524 can monitor the intestine for biomarkers and physiological changes such as lactate, lactate, inflammatory markers, glucose, digestive enzymes, peristalsis, gas bioproducts, pH, temperature and different biomarkers to identify and determine if a leak will occur. If the monitor 530 records signals and trends related to any of these complications, an alarm signal can be transmitted via means such as a light, sound, cellular message, Wi-Fi signal, or other communication channel. The alarm can then be simultaneously communicated to the patient (user), surgeon, caregiver, or other interested parties.

[0144] The system 580 shown in FIG. 5C can detect various forms of complications that may arise in the abdominal cavity 562 or other body areas of the user and includes a catheter 568 that penetrates the user's abdomen via a wound drain 566, such as a surgical trocar. A reservoir 572 outside the user's body can collect drainage fluid and apply negative pressure to the catheter 568 to drain bodily fluids from the abdominal cavity 562, for example, through perforations in the catheter 568 adjacent the abdominal cavity 562. The reservoir 572 can be, for example, a valve, balloon, or drainage bag. Fluids can be drained using negative pressure or without applying negative pressure to the system.

[0145] An in-line monitor 570, housing sensors, computing and communication modules, can monitor fluid draining through catheter 568 and into reservoir 572. In some embodiments, in-line monitor 570 can be attached to wound drainage catheters that are typically used to drain fluid for therapeutic (e.g., to relieve pressure) and diagnostic purposes.

[0146] 5C, in some embodiments, the in-line monitoring device 570 is external to the user's body. The sensors may include sensors such as, for example, sensor 106, sensor 220, sensor array 320, sensor 504, or other suitable sensors described herein, for detecting, for example, pH, temperature, impedance, conductivity, and / or electrolytes in the fluid flowing from the abdominal cavity 562. The computation and communication modules of the in-line monitoring device 570 may be embodied as a computing device, such as computing device 1000, described in further detail herein.

[0147] The in-line monitor 570 may include one or more inlets and outlets. The catheter 568 is in fluid communication with the inlet of the monitor 570, and the reservoir 572 is in fluid communication with the outlet of the in-line monitor 570. The inlet and / or outlet of the in-line monitor 570 may conform to standard catheter sizes to fit existing peritoneal drains. For example, catheter sizes may typically range from 3mm to 10mm in diameter (9FR to 30FR).

[0148] A flow meter 574 may be installed in the fluid pathway between the abdominal cavity 562 and the reservoir 572, for example, in line with the catheter 568 and adjacent in-line monitor 570 and / or reservoir 572, to measure fluid flow rate. The flow meter 574 may be used, for example, to detect blockages in the catheter 568 or to determine if the reservoir 572 is at a fluid volume. The flow meter 574 may be a mechanical (e.g., turbine-based), solid-state (e.g., MEMS, heat transfer), ultrasonic, or other suitable flow detector. The flow meter 574 may send a signal regarding the flow data to the in-line monitor 570, for example, to alert a user of a lack of fluid flow.

[0149] In some embodiments, multiple flow meters, such as flow meter 574, may be placed along the fluid pathway between catheter 568 or abdominal cavity 562 and reservoir 572.

[0150] In some embodiments, the in-line monitor 570 may include multiple inlets and outlets to provide the in-line monitor 570 with multiple independent channels through which fluid can flow. These multiple channels may be fed from a single, split or multiple catheters 568 in contact at or adjacent the peritoneal cavity 562. In this manner, the multiple channels of the in-line monitor 570 may function in parallel, each performing the same or different sensing functions.

[0151] The in-line monitoring device 570 may be placed on the user immediately after surgery or during the post-operative period.

[0152] Conveniently, being non-invasive, the in-line monitoring device 570 can be installed in the user at any time as long as a wound drainage catheter has already been implanted. This can be advantageous as the device can be installed post-operatively to detect complications early, after a complication is already suspected and such a complication is diagnosed, or proactively after a diagnosis to guide an intervention by evaluating its effectiveness and providing timely feedback to the clinical team. For example, if a post-operative leak occurs and an endoscopic intervention is performed accordingly to seal the leak, the device 570 can monitor the drainage to evaluate the effectiveness of such intervention and whether the leak has been sealed.

[0153] Additionally, the fact that device 570 is non-invasive and monitors exudate in vitro allows the use of sensors that may not necessarily be biocompatible and may not require sterilization.

[0154] System 580 can be used to determine a user condition, such as a clinical condition. Such a condition may be the occurrence of a leak, and system 580 can predict the future occurrence of a leak using techniques described herein, based at least in part on data from sensors in in-line monitor 570 and flow meter 574.

[0155] In use, there may be latency in the response sensed by the in-line monitoring device 570 due to the distance from the abdominal cavity 562. There may be fluid mixing between the abdominal cavity 562 and the in-line monitoring device 570 where sensing occurs. Thus, the signal detected may be smaller and more sensitive sensor hardware may be used.

[0156] Because the in-line monitoring device 570 is sensing at a location away from the surgical site, such as the abdominal cavity 562, the fluids sensed may be mixed and / or diluted, which may be taken into account by the in-line monitoring device 570 via hardware and / or software.

[0157] In some embodiments, the software of the in-line monitor 570 can estimate the effect of mixing the fluids before or as they reach the in-line monitor 570. For example, the volume and amount of fluid draining from the abdominal cavity 562 can be determined based on the readings of the flow meter 574. The volume and amount of fluid movement can be used to determine a user condition, the occurrence of a leak, or a prediction of future occurrence of a leak in the user, in conjunction with other techniques described herein. For example, gastric fluid has a low pH. If an increase in fluid flow is detected along with a decrease in pH, even if the pH is detected at a level not as low as would be expected by the presence of gastric fluid, the detected increase in volumetric flow rate can indicate that the gastric fluid has been diluted or mixed, and thus the detected pH level can indicate the presence of a substance (e.g., leaking gastric fluid) that has a lower pH level than the current pH reading could otherwise indicate.

[0158] The in-line monitor 570 can also take into account different sensed variables and how they interact with each other. Some sensors of the in-line monitor 570 may not affect the fluid sample being sensed. Other sensors of the in-line monitor 570 may affect the fluid sample being sensed, for example by breaking down molecules. An example of this is lactate. Lactate may be broken down in order to measure it. Depending on the flow rate of fluid passing through the in-line monitor 570, for example in the case of a blockage, new sample fluid may not be available. Since the lactate originally present may be broken down when it was previously measured, the in-line monitor 570 may sense less lactate than is actually present from the user's peritoneal cavity. Thus, the sensed fluid flow may be used to account for the readings of other sensors.

[0159] The in-line monitoring device 570 can also take into account that while sensing the fluid, the fluid has left the user's body and there is no further diffusion into the tissue at the sensing location, and therefore the analyte is not replenished and may decrease in concentration due to sensory interactions (e.g., molecular destruction due to redox reactions).

[0160] In some embodiments, the monitoring device 570 may also include visual and audio devices capable of signaling a healthcare provider, for example, by audio or visual alarms, hi some embodiments, the monitoring device 570 may include a wireless transmission system capable of communicating with an external computing device.

[0161] In some embodiments, a sensor, such as sensor 106, sensor 220, sensor array 320, or other sensors described herein, may be provided in system 580 within a lumen of catheter 568. Catheter 568 may be labeled to identify the location of the sensor such that during use, catheter 568 may be in a position such that the sensor is outside the user's body. The label may provide a visual indicator (visible through the body of the catheter) of the sensor's location such that a person can visually determine whether the sensor is outside the user's body.

[0162] In some embodiments, fluid may be drawn from abdominal cavity 562 through catheter 568 and in-line monitoring device 570 by gravity, for example into a drainage collection bag (not shown). In some embodiments, fluid may be drawn from abdominal cavity 562 through catheter 568 and in-line monitoring device 570 by capillary action.

[0163] FIG. 5D is a schematic diagram of a system 590 including a sensor device embodied as an in-line monitoring device 1500, according to one embodiment.

[0164] System 590 may be generally similar in structure and components to system 580 , including catheter 568 , reservoir 572 and wound drain 566 .

[0165] FIG. 5E illustrates a configuration of a system 590 having an in-line monitoring device 1500 positioned adjacent to the rib cage, according to one embodiment.

[0166] As shown in FIG. 5E, in use, the system 590 can include a drainage catheter 594 implanted in a user's pleural cavity 592 for draining the pleural cavity 592, for example, following thoracic surgery.

[0167] FIG. 5F illustrates an embodiment of a system 590 that includes an in-line monitoring device 1500 implanted in the abdomen.

[0168] 5H is a front view of the in-line monitoring device 1500. FIG 5H is a side perspective view of the in-line monitoring device 1500. FIG 5I is a top perspective view of the in-line monitoring device 1500.

[0169] The in-line device 1500 can be installed at any time during or after surgery, the patient has a drain implanted post-operatively (e.g., in interventional radiology), the in-line device 1500 may be installed preemptively before a complication is suspected, after a complication is suspected for further monitoring and diagnosis, or during an intervention to assess its intervention effectiveness and guide further intervention for proactive, continuous monitoring of the patient.

[0170] In some embodiments, the inline device 1500 can be attached to the user by hooks, loops, clips, hook-and-loop fasteners (such as Velcro™), or other methods to minimize the risk of dislodgment (e.g., due to patient movement) and the burden on the patient of constantly holding the device.

[0171] In some embodiments, the in-line device 1500 can be attached to the patient's clothing near the wound or reservoir by hooks, loops, clips, hook-and-loop fasteners (such as Velcro™), or other methods to minimize the risk of dislodging (e.g., due to patient movement) and the burden on the user of constantly holding the device.

[0172] In some embodiments, the sensor may be located in a channel of the in-line device 1500 outside the user's body anywhere along the path of the fluid from the surgical drain to its reservoir. In some embodiments, multiple sensors may be located on one substrate located in one system along the length of the catheter 568.

[0173] In some embodiments, the in-line device 1500 includes a sensor assembly 1502 having a port 1504 as an input and an output in fluid communication with a fluid channel 1506 in the sensor assembly 1502 .

[0174] The sensor assembly can be in communication with a signal conditioning circuit (not shown). The signal conditioning circuit may be a filtering and buffering circuit and may include a suitable microcontroller. The signal conditioning circuit may be configured to provide electrical excitation and sensing for example to sensing electrodes and to amplify weak signals measured using an analog-to-digital converter (ADC).

[0175] 16A is a perspective view of a sensor assembly 1502 of an in-line monitoring device 1500, according to one embodiment. The sensor assembly 1502, according to one embodiment, includes a sensor disposed on a substrate 1508 and embedded within a fluidic channel 1506, in contact with the fluid, as well as air bubbles and particles within the fluidic channel 1506. The sensors of the sensor assembly 1502 can include sensors and biosensors described herein. The sensors may be connectable, for example electronically, with other components of the in-line monitoring device 1500 by an interface providing a wire connector 1510.

[0176] The sensor assembly 1502 can include a notch 1501 that can engage with a component of the in-line monitoring device 1500 for attachment to the in-line monitoring device 1500, such as by a snap fit.

[0177] In some embodiments, the sensor assembly 1502 may include one or more ports 1504 that interface with the user's wound or body part and reservoir 572 via the catheter 568 (inlet and outlet, respectively) and are in fluid communication with a fluid channel 1508 in the sensor assembly 1502 of the in-line monitoring device 1500 through which a sensor is embedded and through which fluid flows.

[0178] The ports 1504 can be positioned parallel or near-parallel to allow for parallel or near-parallel attachment of the catheter 568, for example as shown in FIG. 5D, which can minimize the risk of kinking, blockage, and overall device footprint, and can facilitate attachment of the device 1500 to a reservoir 572, patient clothing, or a separate hanging structure.

[0179] In some embodiments, the sensor assembly 1502 can include two ports 1504, or more than two ports 1504, for example, if the user has one or more catheters attached.

[0180] 16B is a cross-sectional view of the sensor assembly 1502 along line II. FIG 16C is a cross-sectional view of the sensor assembly of FIG 16A along line II with suspended particles 1590 in the fluid channel 1506.

[0181] The sensor assembly 1502 can include sensors as described herein. The sensors may be similar to sensors 106, 220, 320, and 504 described herein to measure any of the biomarkers described above, such as pH, lactate, temperature, amylase, impedance, or flow rate.

[0182] As shown in FIGS. 16B and 16C, the sensor in one embodiment of the sensor assembly 1502 can include a reference electrode 1511, a pH electrode 1512, a thermistor 1513, a flow sensor 1514, and an impedance electrode 1515.

[0183] In some embodiments, the sensor assembly 1502 includes one or more light-based sensors as described herein.

[0184] The impedance electrodes 1515 may be used to measure the impedance of the fluid by exciting an AC current (typically 1 kHz to 64 kHz) through the electrodes and measuring the generated voltage across the fluid, or vice versa. In some configurations, separate electrodes are used for current excitation and voltage measurement to isolate the voltage across the fluid only and exclude the voltage drop across the electrode-fluid interface from the measurement. If the impedance is normalized by the geometry of the channel, it may be used to calculate the conductivity of the fluid. The geometric coefficient may be empirically calculated using appropriate calibration fluids.

[0185] The conductivity of a fluid can be modeled as the sum of the conductivities of the individual charge carriers (e.g., ions) in solution, where the conductivity of an individual charge carrier is the product of its molar concentration and molar conductivity. The ionic composition of serous fluids is generally well controlled to maintain isotonicity, and thus exudates may have a narrow range of conductivity (approximately 9 to 12 mS / cm) for healthy patients. However, the ionic composition of exudates may be inherently different (e.g., low sodium in gastric juice), less controlled, and may be altered (e.g., increased or decreased) by mixing with luminal fluids (e.g., gastric juice, feces), which may be influenced by the user's diet.

[0186] Furthermore, the conductivity of a fluid can be affected by its temperature, viscosity, and the presence of impurities. Higher viscosity and the presence of impurities typically decrease the conductivity due to lower charge mobility, while higher electrolyte concentrations increase the conductivity due to a greater number of charge carriers (ions in this case). Thus, a decrease in conductivity may indicate luminal leakage, especially if the leaking fluid is more viscous or contains solid impurities (e.g., duodenal fluid).

[0187] In addition to natural changes in conductivity due to physiological changes in serous fluid or mixing of luminal fluid into the exudate when complications occur, conductivity sensing can also be utilized as part of the clinical workflow to confirm the presence of a leak. This is done by administering a fluid of known conductivity to the organ of interest and monitoring the conductivity response of the exudate. For example, if a gastric leak is suspected, the patient can be orally administered an acid wash with a conductivity of approximately 30 mS / cm. If the conductivity of the exudate fluid increases accordingly (even if not as high as the acid wash itself), it can be attributed to the presence of a gastric leak. Similarly, if a rectal leak is suspected, a high conductivity fluid can be administered to the anal side by enema and the conductivity of the exudate monitored accordingly.

[0188] On the other hand, an increase in temperature increases charge mobility and therefore increases conductivity, which is typically reported as percent change in conductivity per degree Celsius. Therefore, a temperature sensor, such as a thermistor 1513, can be included in combination with the conductivity sensor to measure the temperature of the fluid and report a temperature-compensated value.

[0189] Furthermore, by measuring the conductivity of the fluid in segments along the channel, a spatial image of the fluid's conductivity is constructed. The conductivity image of a homogenous fluid may be constant along the channel. On the other hand, if impurities are present (such as, but not limited to, air bubbles and blood clots), the conductivity image will localize such objects within the channel. This is typically observed as a sudden drop in conductivity measured between the electrodes surrounding the object.

[0190] Furthermore, spatial images of the fluid's conductivity may be acquired at a frequency sufficient to track the movement of the fluid, especially impurities, in the channel (approximately 1 to 10 Hz, depending on the channel size). This may be useful to indicate the presence of new fluid in the channel, thus enabling the acquisition of other sensors, increasing accuracy, or increasing the frequency of acquisition, among other actions. This may also be used to estimate the velocity of the fluid, and therefore its flow rate. Finally, the conductivity of the fluid itself, unaffected by impurities, may be measured as the maximum conductivity along any segment of the channel (assuming that impurities are not present along the entire channel).

[0191] Due to trauma to organs and tissues that occurs during surgery, the initial effluent is typically contaminated with non-serous impurities, such as, but not limited to, blood, blood clots, inflammatory markers and proteins, and air bubbles. As the wound heals, the body heals, the initial impurities are expelled, and the body reaches homeostasis, the amount of impurities typically decreases such that the exudate appears as pure serous fluid (typically characterized as a light yellow color). The presence of impurities after the initial recovery period (e.g., the first day) after surgery may indicate a complication. For example, the presence of blood or blood clots may indicate continued internal bleeding at the wound site. Similarly, air bubbles may indicate leakage of gas (e.g., air, methane) from a hollow organ. The systems and methods disclosed herein can indicate the presence, size, and amount of impurities, especially in the later stages of retrieval.

[0192] The flow of fluid through the device 1500 may be detected by the flow meter flow sensor 1514. The amount of fluid drained is typically greater in the initial recovery period than in later stages (e.g., greater than 100 mL / day on average the first day, and less than 100 mL / day thereafter). Persistent large amounts of fluid drainage may indicate inflammation, infection, or leakage. The system 580 may utilize flow sensors that operate on the principles of mass heat transfer, the principles described above, or other types to measure the instantaneous flow rate of fluid. This may be used to calculate the total volume of fluid drained within a period of time and help estimate the amount of fluid expected in the near future. The systems and methods disclosed herein may alert if the flow rate is higher than expected after the initial recovery period (determined either by the clinical team or default values ​​based on research) or if there is a sudden increase in flow rate.

[0193] Figure 17A is a perspective view of a sensor assembly 1502' having two substrates 1508 containing light-based sensors, according to one embodiment, and Figure 17B is a cross-sectional view of the sensor assembly 1502' along line II-II.

[0194] The sensor assembly 1502 ′ may be generally similar in structure and components to the sensor assembly 1502 , including the notch 1501 , the port 1504 , the fluid channel 1506 , two of the substrates 1508 , and two of the wire connectors 1510 .

[0195] The sensor assembly 1502' may include an optical-based sensor, as described herein.

[0196] In some embodiments, as shown in FIG. 17B, the light-based sensor of the sensor assembly 1502′ includes a light source 1522 and a light detector 1524 disposed on a separate substrate 1508 and embedded within the fluid channel 1506 across from one another to measure light transmittance through fluid passing through the fluid channel 1506, according to one embodiment.

[0197] FIG. 18A is a perspective view of a sensor assembly 1502'' having a fiber optic light-based sensor, according to one embodiment. FIG. 18B is a cross-sectional view of the sensor assembly 1502'' along line III-III.

[0198] The sensor assembly 1502 ″ may be generally similar in structure and components to the sensor assembly 1502 , including the notch 1501 , the port 1504 and the fluid channel 1506 , and the sensor assembly 1502 ′.

[0199] The sensor assembly 1502'' may include an optical-based sensor, as described herein.

[0200] 18B, the light-based sensor of the sensor assembly 1502'' includes optical fibers for transmitting and receiving light. In particular, according to one embodiment, light is directed into a channel via an optical fiber 1532 and received across the channel by another optical fiber 1532 to measure the light transmission through the fluid in the fluid channel 1506.

[0201] Figure 19A is a perspective view of a sensor assembly 1502''' having an optical-based sensor, according to one embodiment. Figure 19B is a cross-sectional view of the sensor assembly 1502''' along line IV-IV.

[0202] Sensor assembly 1502 ″″ may be generally similar in structure and components to sensor assembly 1502 , sensor assembly 1502 ′, and sensor assembly 1502 ″, including notch 1501 , port 1504 , fluid channel 1506 , and wire connector 1510 .

[0203] The sensor assembly 1502''' may include an optical-based sensor, as described herein.

[0204] In some embodiments, the substrate 1508 of the sensor assembly 1502''' includes a rigid substrate section and a flexible substrate 1518 in the bending region, as shown in FIG. 19B.

[0205] As shown in FIG. 19B, according to one embodiment, the light-based sensor of the sensor assembly 1502'' includes a light source 1526 and a detector 1528 disposed on a single rigid flex substrate 1508 and embedded perpendicularly within the fluid channel 1506 to measure light scattering by the fluid in the fluid channel 1506.

[0206] In some embodiments, the light source 1526 and the light detector 1528 may be positioned at an orthogonal angle to measure the turbidity of the fluid (ie, the scattering of light by the fluid).

[0207] 6A-6B show an embodiment of a sensor device that can perform its diagnostic applications without the need for the catheter to have wires connecting the sensor to a monitor and without the need for a dedicated lumen for wiring, including the sensors described herein. The illustrated detection system can perform the sensing function, take the raw signals, and convert them so that they can be transmitted to an external receiver. The illustrated system may require a power module, which may be accomplished by having a battery installed in the system, via a power harvesting solution or inductive power transmission. Furthermore, the sensor may not require the monitor to be located near the patient. Furthermore, according to this embodiment, the system can store data readings and transmit data only when the monitor is within communication distance, allowing the user (patient) to not carry additional equipment. In addition to this, the user may not need a monitor, and the health care provider can use the monitor to collect data during a hospital visit.

[0208] FIG. 6A shows a system 600 having an array of sensors 620, an integrated circuit 604, and a trace antenna 610 for a catheter 602 to transmit signals. Alternatively, the antenna may be a conformal antenna. The integrated circuit 604 may include a microcontroller to process data and connect to a battery. A transceiver may also be incorporated to wirelessly transmit data via the antenna. Additionally, this embodiment shows a three-electrode system in which an active electrode 616, a reference electrode 612, and a counter electrode 614 are shown. The system may be designed such that the sensor can collect data and the integrated circuit can process the data so that the data can be wirelessly transmitted to a receiver outside the body.

[0209] FIG. 6B shows a system 630 having an array of sensors 650, an integrated circuit 634, and a helical antenna 640 for a catheter 632 to transmit signals. The system can be designed so that the helical antenna 640 can be embedded inside the wall of the catheter to align with the catheter design. The integrated circuit 634 can have a microcontroller to process the data and connect to a battery. A transceiver can also be incorporated to transmit data wirelessly via the antenna. Additionally, this embodiment shows a three-electrode system where an active electrode 646, a reference electrode 642, and a counter electrode 644 are shown. The system can be designed so that the sensor can collect data and the integrated circuit can process the data so that the data can be transmitted wirelessly to a receiver outside the body.

[0210] 7 is a schematic diagram of one embodiment of a system 700 that can be utilized to monitor the status of a sensor device 710 and relay a signal to another device or end user. In one embodiment of the system, the sensor device 710 includes a catheter and adapter having an array of sensors 712 with at least one sensor used to monitor the status of a patient after surgery.

[0211] Components of the systems described herein, such as system 590, may be incorporated into system 700. It will be understood that sensor device 710 may be embodied as any sensor device described herein and monitor 720 may be embodied as any monitor or DAQ described herein. In some embodiments, sensor device 710 and monitor 720 may be embodied as in-line monitoring device 1500. Sensor 712 may be any sensor described herein.

[0212] The system 700 may utilize a single sensor 712 to perform the monitoring or may utilize a system of multiple sensors to monitor the patient. Also, according to the present embodiment, the system may utilize a single type of sensor or may use different types of sensors to sense different biomarkers, as described herein.

[0213] The sensor 712 may be connected to a signal conditioning circuit 714. The circuit 714 may perform different functions such as buffering, filtering, amplifying, encrypting, and converting the signal so that it can be read by an analog-to-digital converter (ADC) 722.

[0214] The signal conditioning circuitry 714 may also be connected to a non-volatile memory unit 716 for accessing calibration data and calibrating the sensor measurements.

[0215] The ADC 722 and signal conditioning circuitry 714 may be located either on the catheter, in the monitor 720, or in an adapter attached to the catheter. In some embodiments, the sensor device 710 is connected to the monitor 720 by a wired connection.

[0216] The system 700 can be connected to an ADC 722 housed inside the monitor 720, which in turn can be connected to a microcontroller 730. The microcontroller 730 can store the signals in a removable memory 724. The stored data can include raw signals, processed signals, and metadata about the user (patient) such as age, gender, medical history, type of surgery, etc. The microcontroller can also use this information while monitoring and analyzing the signals to determine if the patient has suffered a post-operative leak. The removable memory 724 can take different forms such as a secure digital (SD) card, flash memory, floppy disk, optical disk, or other suitable forms of removable memory.

[0217] The monitor 720 may also have a connector 726 that may allow data transfer to and from an external host, charge the system, control external devices, or flash firmware for the system. The monitor 720 may also include a power source, such as a battery 728, for powering the system.

[0218] The monitor 720 may also have components that can relay signals directly to a user. Also, according to this embodiment, the system may utilize components such as a speaker 732, a display 736, a light 734, and other elements that may be used to communicate with a user 746, or a computing device associated with the user 746. The system may issue an alarm when an early sign of a complication occurs. Similarly, the system may signal an alarm if a complication or leak is identified. Different alarms may be signaled for different complications. A user 746, such as a health care provider, may be provided with additional information related to the alarm by viewing visual feedback from the light 734 or the display 736. There may also be audio cues that may be signaled via the speaker 732. The user 746 may also have access to further details related to the data captured by the sensor by accessing the removable memory 724 or via the connector 726.

[0219] The monitor 720 may be equipped with a wireless transceiver 738 and antenna 740 to enable wireless monitoring of the patient. The system may enable wireless monitoring over short distances using systems such as Wi-Fi, Medical Body Area Network (MBAN), Bluetooth, Zigbee, Near Field Communication (NFC), infrared transmission, or other short-range network protocols. The system may also be configured to communicate over longer distances by utilizing systems such as cellular networks, Low Power Wide Area Networks (LPWAN), Lora, or other long-range network protocols. This may therefore enable the system to function in a hospital on-site setting or as an at-home monitoring device for a user. Data communicated wirelessly may be relayed to a remote server 742 that can be accessed by a user 744.

[0220] The remote server 742 may include one or more computer servers and may include local, remote, cloud-based, or software as a service platform (SAAS) servers.

[0221] The monitor 720 may include software capable of displaying data obtained from the sensors. The monitor software may also display processed data obtained from the sensors. The monitor software may also display simple messages alerting the patient to a possible complication or the status of a possible complication.

[0222] In some embodiments, the system 700 may be designed to be completely wireless with no wired connection between the sensor device 710 and the monitor 720. As shown in Figures 6A and 6B, all components can be integrated into one device and placed on the catheter. In this case, the sensor device 710 can be expanded with included elements such as an antenna 740, a wireless transceiver 738, a microcontroller 730, a power solution, and other components to complete the system.

[0223] In another embodiment, a computing device can be used to access data collected and stored in the monitor 720. Software utilized on the computing device can be used to access raw or processed data from the device. The software can be further configured to allow a user to gather information regarding algorithms and calculations performed to determine the clinical status of the patient. The software may also be utilized to determine the clinical status of the patient or to display information obtained from the sensors.

[0224] In some embodiments, the data may be stored locally or remotely. To protect patient safety, the data may be encrypted to comply with security regulations set forth by government and regulatory agencies. Encryption may occur prior to data processing on the microcontroller 730. Encryption may also occur on data as it is being entered into the system.

[0225] FIG. 8 illustrates a process flow diagram of an embodiment that addresses a use case of the device. A surgeon first performs an anastomosis in the user's gastrointestinal (GI) tract, such as the stomach, small intestine, large intestine, colon, or rectum (812). The surgeon can then surgically place a catheter with a biosensor in an area proximate to the surgical line (814). The surgeon can place the catheter in a nearby cavity, deep in the pelvis, or elsewhere in the peritoneum where the fluid collects, to come into contact with the peritoneal fluid. At the distal end (external portion) of the catheter, the surgeon can then attach a monitor to establish a connection with the biosensor on the catheter (816). The system can then monitor for peritoneal fluid present in the body cavity, allowing the system to monitor the patient (818).

[0226] If the user (patient) develops early signs of a leak (820), the biosensor can monitor environmental changes in the fluid and identify different biomarkers that may be associated with the occurrence of a leak. Depending on the nature of the reading obtained from the biosensor, the monitor can alert the user and inform them to seek immediate medical attention. The monitor can also continue to collect information as complications develop to identify further trends of complications. If a leak occurs (822) and luminal contents leak into the peritoneum, the monitor can alert the user of the situation and inform them of the nature of the complication as well as inform them to seek immediate medical attention.

[0227] FIG. 9 shows a biosensor plot captured over a period of time, for example, by the system 700. Specifically, in this embodiment, three pH curves are shown captured over a period of time 900 after the catheter (with biosensor) is placed in the peritoneum of the user. Thus, the sensor is monitoring the ascites in the body. In the first curve 910, the steady state curve of the biosensor can be seen. The blue squares indicate independent data points that have been captured, and the solid line 912 indicates the data that is being processed by the monitor. In the first curve 910, based on the steady state, it may be possible to deduce that there are no significant changes that may indicate a complication. This is due to the fact that the body is typically very good at regulating pH, plus the area typically has a constant reading.

[0228] The second curve 920 shows a different trend where the initial reading of curve 922 shows a steady state reading, then rises, then shows another steady state reading. This is abnormal compared to the initial reading shown at 910. The monitor can then process the data to create a new curve 930 with a trend line 932. The data shown at 934 shows that the general trend is an increase in pH, which may be related to different forms of leakage or infection. The first data point that the system can analyze is the steady state reading, which stabilizes to determine the peritoneal pH, allowing for the determination of several clinical factors. Another data point that can be further analyzed to predict the patient's clinical status is the full width at half maximum (FWHM) to determine if a leak is occurring, the type of leak and its occurrence. The system can also further analyze another data point, which is the rate of change of pH during the rising and falling peaks, to determine factors such as the leak cause, the leak rate, the type of leak, the location of the leak, and when the leak occurred.

[0229] Also according to this embodiment, the data may be accessed by displaying it directly on the monitor or by using a local connector installed on the monitor 726. The data may also be accessed remotely using the remote server 742, allowing a healthcare provider to monitor a patient without the patient needing to be available at a medical facility.

[0230] In some embodiments, the microcontroller 730 of the monitor 720 may be embodied as a computing device, such as computing device 1000. In some embodiments, the monitor 720 may be embodied as a mobile computing device.

[0231] 10 is a high-level block diagram of an example computing device 1000. As will become apparent, the computing device 1000 can receive data, such as biosignal data, for processing by one or more processors 1210 under software control to analyze the signal data. The processed signal data may be displayed, for example, on a display 736 or communicated over a network to another device, such as a remote server 742.

[0232] As shown, computing device 1000 includes one or more processors 1210 , memory 1220 , a network controller 1230 , and one or more I / O interfaces 1240 , which communicate via a bus 1250 .

[0233] The processor 1210 may be one or more of an Intel x86, Intel x64, AMD x86-64, PowerPC, ARM processor, TI MSP430, etc.

[0234] The memory 1220 may include random access memory, read-only memory, or persistent storage such as a hard disk, solid-state drive, etc. The read-only memory or persistent storage is a computer-readable medium. The computer-readable medium may be organized using a file system and controlled and managed by an operating system, which manages the overall operation of the computing device.

[0235] The network controller 1230 serves as a communications device for interconnecting the computing device with one or more computer networks, such as a local area network (LAN) or the Internet. The computing device 1000 may communicate with, for example, the sensor device 710, a remote server 742, and a computing device non-volatile memory 716 associated with a user 746 via the network controller 1230.

[0236] One or more I / O interfaces 1240 may serve to interconnect the computing device with peripheral devices, such as, for example, a keyboard, a mouse, a video display, etc. Such peripheral devices may include a display of device 1000. Optionally, network controller 1230 may be accessed via one or more I / O interfaces.

[0237] The software instructions are executed by the processor(s) 1210 from a computer-readable medium. For example, the software may be loaded from persistent storage in the memory 1220 or from one or more devices via the I / O interface 1240 into a random access memory and executed by the one or more processors 1210. As another example, the software may be loaded and executed by the one or more processors 1210 directly from a read-only memory.

[0238] In some embodiments, computing device 1000 may be an embedded system or microcontroller that includes a processor, memory, and input / output (I / O) peripherals on a single integrated circuit or chip to execute processes and store instructions and data as described herein. In one example, computing device 1000 may be a microcontroller, such as an Arduino board and associated software system.

[0239] 11 illustrates a simplified configuration of exemplary software components and data stored within memory 1220 of computing device 1000. As illustrated, these software components may include operating system (OS) software 1310, signal processor 1320, calibrator 1330, user profiler 1340, predictor 1350, signal data store 1380, and user profile data store 1390.

[0240] The operating system 1310 may enable basic communication and application operations associated with a mobile device. In general, the operating system 1310 is responsible for determining the functions and features available on the device 1000, such as a keyboard, touch screen, synchronization with applications, email, text messaging, and other communication features, as would be envisioned by one skilled in the art. In one embodiment, the operating system 1310 may be Android™ operating system software, Linux™ operating system software, BSD-derived operating system software, iOS™ operating system software, or any other suitable operating system software. In embodiments in which the Android operating system platform is used, the software components described herein may be implemented using features of a framework API (application programming interface) for the Android platform.

[0241] The signal processor 1320 receives signal data from the signal conditioning circuit 714, for example, measured from a sensor such as a biosensor described herein.

[0242] In some embodiments, the signal processor 1320 can process the signal data into a format for use by other software. This can include metadata such as calibration factors and sampling parameters. The sensory data may be compressed, encrypted, or pre-calibrated and may be stored in binary, text, or other formats.

[0243] In some embodiments, the signal processor 1320 can operate to contextualize the received signal, e.g., pH change. For example, the sensor output may vary slowly over time. Such drift can be corrected in software if the sensor is well modeled or if the constraints of significant change (e.g., amplitude, rate of change, etc.) are known.

[0244] The processed or unprocessed signal data may be stored in a signal data store 1380.

[0245] The signal processor 1320 can determine a user state based at least in part on the sensor data detected by the signal sensor. In some embodiments, the user state may be based at least in part on a user profile, as described in further detail below.

[0246] In some embodiments, the user state may be based at least in part on relative admittance (amplitude and phase) over a range of frequencies as previously correlated with the user state.

[0247] In some embodiments, the user condition is based at least in part on a pH level measured in a drainage fluid within the user's body or outside the patient's body.

[0248] In some embodiments, the user condition is based at least in part on changes in pH levels detected within the patient's body or in drainage fluids external to the patient's body.

[0249] In some embodiments the user condition indicates the presence of fluid in the user's body.

[0250] In some embodiments, the user condition is based at least in part on an increase or decrease in the amount of fluid expelled from the user's body.

[0251] In some embodiments, the user state is based at least in part on multivariate statistical techniques that transform data from multiple sensors into alternative subspaces that facilitate characterization of fluids and identification of their components.

[0252] In some embodiments, the user state is based at least in part on a multivariate linear transformation from multiple sensors, such as principal component analysis (PCA), which facilitates characterization and identification of fluids and their components.

[0253] In some embodiments, the user state is based at least in part on a cross-correlation of the sensory data with pre-identified characteristic curves for various user states.

[0254] In some embodiments, the user state is based at least in part on the absolute output of a biosensor, such as pH, impedance, conductivity, lactate concentration, amylase concentration, light absorption or transmission, or other biosensor.

[0255] In some embodiments, the user condition is based at least in part on a rate of change measured by a biosensor such as pH, impedance, conductivity, lactate concentration, amylase concentration, light absorption or transmission, or other biosensor.

[0256] In some embodiments, the user condition is based at least in part on cross-correlation of biosensor output with existing trends in the user condition using biosensors such as pH, impedance, conductivity, lactate concentration, amylase concentration, light absorption or transmission, or other biosensors.

[0257] In some embodiments, the user state is based at least in part on the output of all sensors of the sensor device, including but not limited to the sensors disclosed herein.

[0258] In some embodiments, the user state is based at least in part on changes in sensed values ​​among a plurality of sensors.

[0259] In some embodiments, the signal processor 1320 may monitor primary conditions, such as pH, as well as secondary conditions, such as detecting temperature to detect a fever in the user. The secondary conditions may be considered in combination with the primary conditions by the predictor 1350, described in more detail below. In some embodiments, the primary and secondary conditions may be evaluated based on the time of the conditions, for example, the time between the primary condition occurring and the secondary condition occurring.

[0260] In some embodiments, the signal processor 1320 may be configured to evaluate various criteria to prompt an alert, for example, to a caregiver or health care professional. The criteria may be defined by a user.

[0261] In some embodiments, the criteria may be defined as the detection of air bubbles, for example, by an impedance sensor as described herein. When the user-defined criteria is detected by the appropriate sensor, an alert is sent to a caregiver or health care professional. Because air bubbles are typically not present after an initial drainage period (approximately 1 day), the presence of air bubbles may indicate gas leakage due to anastomotic leakage.

[0262] In some embodiments, the criteria may be defined as an increase in the ratio of air bubbles to fluid above a threshold, for example as detected by an impedance sensor as described herein. When the criteria is detected by an appropriate sensor, an alarm is sent to a caregiver or health care professional. Because air bubbles are typically not present after an initial drainage period (approximately 1 day), the presence of air bubbles may indicate gas leakage due to anastomotic leakage.

[0263] In some embodiments, the criterion may be defined as a flow rate that has decreased below a threshold for a sustained period of time, and when the criterion is detected, an alert is sent to a caregiver or health care professional. Conveniently, this may allow for timely detection of catheter blockages that may be detrimental to the patient's health, especially when the wound drain is used for clinical purposes, and may assist the clinician in determining when to remove the wound drain.

[0264] In some embodiments, the criteria may be defined as a concentration of amylase exceeding a threshold detected by an amylase sensor described herein, which may be indicative of, for example, a pancreatic leak. Once the criteria is detected, an alert may be sent to a caregiver or health care professional.

[0265] The calibrator 1330 is configured to calibrate settings of the sensor device 710, for example, to standardize the signal relative to the user's body being detected by the sensor.

[0266] In some embodiments, calibration may be performed by inserting a calibration fluid into the sensor device 710 through a catheter.

[0267] The calibrator 1330 can operate on data collected while pumping different fluids into the catheter, as described herein, allowing the biosensor to calibrate.

[0268] The user profiler 1340 is configured to generate and update a profile for a user.

[0269] In some embodiments, signal data received from the sensor devices may be aggregated and associated with a user, e.g., over time, to create a profile for that user. In some embodiments, user profile information, such as signal data associated with one or more users, may be applied to machine learning techniques to develop models of such signal data.

[0270] The user profile may include information about the user, such as information related to surgical procedures performed on the user and the date and time of the surgical procedure, the location of the surgical procedure, the date and time of insertion of the sensor device, the location of insertion of the sensor device, the user's age, height, weight, medical history, condition or illness (e.g., diabetic), current or past medications used by the user, or other current or past factors related to the user, surgery, or device details.

[0271] In some embodiments, the user profile includes a list of medications used by the user, which may be used to identify potential sources of error caused by medications that alter one or more thresholds of a biosignal being measured using the sensors described herein.

[0272] In some embodiments, the user profile includes procedures that have been performed on the patient. Such a list of procedures can be used to further analyze a potential list of complications that the user may suffer, given the risks of each procedure. Additionally, such a list of procedures can be used to identify anatomical structures of biological fluids proximate to the procedure location.

[0273] In some embodiments, the information regarding the surgical procedure performed on the user includes the date and time of the surgical procedure. Further, the date and time of surgery can be used to analyze the user's condition taking into account the entire timeline of the user's recovery.

[0274] In some embodiments, the user profile data may be entered by a user, a healthcare institution, or may be entered by a healthcare professional, for example a surgeon may enter information about a surgery performed and details about the sensor device used after surgery (e.g., operating parameters, number and type of sensors, etc.).

[0275] In some embodiments, the user profile may be generated automatically, for example from a health record detailing a surgery or the user's electronic health record, which may be received from a computing device in communication with the system 100.

[0276] In some embodiments, the user profile may include information identifying factors associated with a user state determined from collected signal data.

[0277] In some embodiments, user profiles including signal data may be collected for one or more users of the system 700 or instances of the system 700 .

[0278] User profile information, user status, and criteria may be stored in a user profile data store 1390.

[0279] The user profile may be updated based at least in part on the sensor data from the sensors described herein.

[0280] The signal data associated with a particular user may be used by the predictor 1350 for further analysis of the signal data and leakage prediction, as described in more detail below.

[0281] The predictor 1350 is configured to perform data analysis and algorithms, such as machine learning techniques, to detect leaks and determine if a leak has occurred. In some embodiments, the predictor 1350 can predict a future occurrence of a leak based on data received from a sensor, such as the time when a user condition occurred and the length of time that the user condition occurred.

[0282] In one example, a user condition indicated by sensor data occurring during a transient period, for example indicating a transient spike, may not indicate that particular condition and may instead be discarded as an anomaly.

[0283] In some embodiments, the future occurrence of a complication, such as an anastomotic leak, may be predicted based at least in part on the time at which the user condition occurs and the length of time that the user condition occurs.

[0284] Machine learning algorithms may be applied to previously acquired signal data associated with a user state. For example, pattern recognition may be performed on previously acquired signal data associated with a particular user state. The machine learning may generate a user state classification model trained by the previously acquired signal data.

[0285] Leaks may be predicted by analysis of changes in the flow of the fluid surrounding the sensor of the sensor device, for example, how quickly the flow changes may indicate how quickly a leak is flowing.

[0286] In another example, leakage can be predicted based on the accumulation of lactic acid detected by a sensor.

[0287] In another example, a leak may be predicted based on oxygen depletion detected by a sensor.

[0288] In another example, a leak can be predicted based on a detected pH change, which can include an analysis of why the pH changed to distinguish between different causes or conditions of such a pH change. For example, the predictor 1350 can distinguish between a pH change that is likely caused by a leak and a pH change that is caused by a medication being used by the user, which can be information generated or stored by the user profiler 1340.

[0289] In some embodiments, the future occurrence of anastomotic leakage may be predicted based on a user's condition being above or below a certain threshold. Such a threshold may be, for example, a pH value.

[0290] As described above, a secondary condition or second user condition may be determined from the sensor data. A future occurrence of a leak may be predicted based at least in part on the second user condition. The second user condition may also be indicative of a risk factor or risk level of the leak condition.

[0291] In some embodiments, a Kalman filter can be used to predict whether a leak has occurred.

[0292] Predictive analysis of biosignals may involve the detection of certain physiological changes that typically occur before a leak occurs, and the use of biomarkers associated with such changes.

[0293] In some embodiments, the predictor 1350 can determine a confidence level as to whether a leak has occurred based on a combined analysis of the user profile and the processed biosignals. Weighting factors based on the user's profile and current state can be used to contextualize the algorithm inputs / outputs according to the likelihood that a leak has occurred. These weights can be dynamic over time and updated as the user's state is updated. In one example, if a user has had bariatric surgery, a higher weighting can be applied to a gastric leak detection algorithm compared to a colorectal leak detection algorithm.

[0294] In some embodiments, predictive analysis of signals, such as biosignals from a biosignal sensor, such as the sensor device 101 or the in-line monitoring device 1500, can include diagnosis, e.g., identifying the nature of a leak or disease by examining symptoms monitored by the sensor.

[0295] In some embodiments, a triage state or risk level of a prediction of a future occurrence of a leak can be based on the signal data, the user state, and the user profile. The generated data can include a triage state or risk level.

[0296] Machine learning algorithms may be applied to the previously acquired signal data, the user profile data, and the user condition data. For example, pattern recognition may be performed on the previously acquired signal data associated with a particular leak prediction.

[0297] The data relating to a prediction of a future occurrence of a leak may include a notification of the prediction.

[0298] In some embodiments, signal data can be collected to build trends across multiple patients, and cross-correlation techniques can be used to identify similarities between a patient's data and previous patients, and matches or correlations can indicate risk factors.

[0299] Conveniently, better predictions may be possible because there is better fidelity of data acquired over time, for example continuously as fluid flows through the sensor device, in one example in real time or near real time.

[0300] As will be appreciated, any or all of the hardware or software components described herein may be implemented and / or executed on an external computing device, such as a computing device such as a remote server 742, or on a computing device on the sensor device.

[0301] 12A illustrates a method 2000 for monitoring a user for an anastomotic leakage status. Blocks S2010-S2050 may be performed by the processor(s) 1210. The steps are provided for illustrative purposes, and variations of each step, omission or substitution of various steps, or additional steps are contemplated.

[0302] In block S2010, a user profile is generated by the user profiler 1340. In some embodiments, the user profile may not be associated with the use of leak monitoring.

[0303] In block S2020, sensor data is received from a sensor, such as a biosignal sensor. The biosignal sensor may be disposed on a catheter as part of a sensor device 101 that is inserted into the user's body. In some embodiments, the sensor and / or sensor device 101 may be inserted into a portion of the user's body, such as a body cavity that has had a surgical procedure to be monitored. In some embodiments, the sensor, for example disposed on a sensor device, may be external to the user's body.

[0304] In block S2030, the processor operates to determine a user state based at least in part on the received sensor data.

[0305] In block S2040, the occurrence of an anastomotic leak in a user may be detected and / or a future occurrence of the leak may be predicted by the predictor 1350. In one example, the future occurrence of anastomotic leak may be predicted based on a user condition of a change in pH level in the user's body.

[0306] In some embodiments, control flow may loop back to block S2020 such that the user's state is continuously updated (based on continuously acquired sensor data) and can be used to predict future events.

[0307] The prediction of future occurrence of anastomotic leakage is output in block S2050. In one example, the data can be output to the display 736 of the monitor 720 for viewing by a user.

[0308] In some embodiments, a leak may be detected based on a change in pH value measured by one or more biosignal sensors.

[0309] In some embodiments, a leak may be detected based on the presence of fluid within the user's body.

[0310] In some embodiments, leaks can be detected by taking into account the user's profile, for example the user's height, weight, age, and current list of medications being taken.

[0311] In some embodiments, the occurrence of a future leak may be predicted based on the received sensor data. The prediction may be based on various conditions or trends identified in the vital sign data.

[0312] It should be understood that the blocks may be performed in different sequences or in an interleaved or repeated manner.

[0313] 12B illustrates a method 2100 of monitoring a user. Blocks S2110-S2160 may be performed by processor(s) 1210. The steps are provided for illustrative purposes. Also, variations of each step, omission or substitution of various steps, or additional steps are contemplated.

[0314] At block S2110, a user profile is received that includes information regarding surgical procedures performed on the user.

[0315] At block S2120, flow data is continuously received from a flow sensor in fluid communication with the fluid from the user's body.

[0316] At block S2130, biosignal data is continuously received from a biosensor in fluid communication with the fluid.

[0317] At block S2140, a flow rate of the fluid is determined based at least in part on the flow rate data.

[0318] At block S2150, a condition of the user is determined based at least in part on the flow rate and vital sign data.

[0319] At block S2160, a future occurrence of a complication is predicted based at least in part on the user's condition and the user's profile.

[0320] It should be understood that the blocks may be performed in different sequences or in an interleaved or repeated manner.

[0321] Application Examples

[0322] An example of the application of the systems and methods disclosed herein can be illustrated by looking at a patient who has colorectal cancer and needs to have a tumor removed. The surgeon may decide to perform an anastomosis after removing the tumor from the body. The surgeon may then place a catheter equipped with a biosensor in one of the paracolic gutters if they believe that is the area most likely to collect fluid from a leak. The catheter system they utilize may be equipped with fluid, pH and lactate sensors. Once the catheter is placed, the surgeon may also choose to hold the catheter in place using absorbable sutures. The catheter may then be connected to a monitor placed outside the body. The catheter may also be connected to a balloon that applies negative pressure to drain fluid from the peritoneum. The monitor then confirms that a connection with the biosensor has been established and notifies the user and the surgeon that the patient's condition appears normal. The patient may then remain in the hospital overnight and then be discharged on the second day. The patient may be discharged with the monitor and catheter. Three days after the surgery and after the patient is discharged, the biosensor may detect a clinically relevant pH change and a simultaneous increase in lactate concentration. The monitor can then send a signal to the patient to seek medical attention, or the system can delay the signal to wait for a larger change. The data may be wirelessly relayed to a medical facility, at which point a specialist can view the data and make a decision to have the patient come to the medical facility or not. The system may then detect significant pH changes in the abdominal cavity and relatively high fluid flow. The monitor may then alert the patient to inform the patient that a leak has been detected and that medical intervention should be sought immediately. The medical facility may also be notified. Once the patient arrives at the hospital, the medical facility can view the data obtained from the biosensor and make a clinical decision to assist the patient before complications develop. The surgeon may also decide to perform corrective medical action, including but not limited to reoperation on the patient. The system may be utilized again after corrective action has been taken.

[0323] Conveniently, a sensor device as described herein may be removable from a user or patient in an outpatient setting, for example, by a nurse in the user's home, without the user having to undergo an additional surgical procedure. In one example, this may occur 10-20 days after surgery.

[0324] In some embodiments, integrating the sensor with a catheter (particularly a drain) may allow the sensor device to be removed in an outpatient setting.

[0325] Experimental Data

[0326] Previous experimental studies related to the detection of postoperative anastomotic leakage have recorded preliminary animal study data using a porcine model, with evidence of a decrease in pH due to leakage of highly acidic gastric juice.

[0327] For the preliminary animal study, surgery was performed on each pig's stomach. Two pH biosensors were implanted near the surgical site, and leakage was then induced.

[0328] Table 1 shows the reported GI tract pH values ​​in humans, as shown in FIG.

[0329] In the first study, two sensors were connected to a Digilent Analog Discovery 1 and the remaining four sensors were connected to two Digilent Analog Discovery 2 instruments. Data from all study sensors was recorded using Digilent Waveforms software.

[0330] FIG. 14B and FIG. 14B show gastric sensor data captured during the study ("Stomach from Trial 3"). The graphs in FIG. 14B and FIG. 14B show data for sensors P-03-015 and P-03-016, respectively. When sensor P-03-016 was placed closer to the leak site and the leak was introduced near the 5 minute mark, a larger spike is observed. Additionally, bile was extracted at the end of the study and manually added over sensor P-03-015. As shown, a large spike was observed.

[0331] FIG. 15A shows filtered sensor data captured during the second study. The graphs show sensors implanted next to the stomach. Each graph represents the pH sensor output in mV per location. The vertical dotted lines represent different surgical events during the trial. FIG. 15B shows further study details of FIG. 15B, including the sensitivity offset and location of each sensor. At 1 minute, a control occurred, where the surgeon pretended to induce a leak but did not actually induce one. At 2 minutes, a stomach leak event occurred. At 8 minutes, a bowel leak event occurred. At 12 minutes, a rectal leak event occurred. At 21 minutes, a bowel leak event occurred.

[0332] The plot showing real-time sensor measurements is filtered to remove anomalies (e.g., due to connector issues), reduce noise, and cropped in time to show only relevant intervals.

[0333] These preliminary studies used a pig model, as pigs have a GI tract that is very similar in structure and function to that of humans. The pig's digestive organs function in much the same way as the human digestive organs, but they are much larger in size. The pH levels in the GI tract are presumed to be similar in humans and pigs.

[0334] All data measured in the first study were recorded with an Analog Discovery device and no multimeter was used. The first study graphs (Figure 14A, Figure 14B) show the real-time progression of all sensors, with leakage induced at approximately 5-7.5 minutes. Sensor P-03-016 measured an estimated decrease of 1.9 pH, whereas sensor P-03-015 only measured an estimated decrease of 0.1 pH. However, it was observed that the amount of gastric fluid leakage in this study was less than that in the previous study. Furthermore, sensor P-03-015 was implanted farther from the leak and likely did not come into direct contact with the leaked fluid, hence the insignificant response.

[0335] In conclusion, sensors implanted near the stomach showed a significant decrease in pH due to leakage of highly acidic gastric juices.

[0336] The results validate the use of the sensor device in the GI tract near the surgical site to detect anastomotic leakage after surgery. Trends in pH change can be observed in all three locations.

[0337] In some embodiments, the sensor may be characterized and calibrated to simulate the implant environment (eg, the sensor may be characterized at 37°C).

[0338] In some embodiments, techniques can be implemented to reduce the mismatch between sensor offsets and reduce the offset drift over time, which may involve the use of different materials as the PR.

[0339] In some embodiments, the use of custom collection settings can reduce noise, isolate the sensor from power lines for safety, dampen temporal drift, reduce sensor leakage current, and reduce sensor crosstalk, allowing for more accurate estimation of pH changes.

[0340] Of course, the above-described embodiments are intended to be illustrative only and are in no way limiting. It will be apparent to those skilled in the art that various modifications and variations can be made to the materials, devices, and methods disclosed herein. It will be understood that the elements of the embodiments are not necessarily mutually exclusive, and many embodiments can be appropriately combined with other embodiments. For example, a sensor device can be manufactured using various specific combinations of components such as sensors in various specific ways in combination with support substrates of different materials, shapes, and configurations.

[0341] The above and illustrated examples are intended as examples only, and the description is to be understood to encompass all equivalents.

[0342] The described embodiments are susceptible to many changes in form, arrangement of parts, details and order of operation, and the present disclosure is intended to encompass all such modifications within its scope as defined by the claims.

Claims

1. one or more input ports attachable to one or more catheters inserted into a user's body, the input ports in fluid communication with the catheters for receiving fluid from the user's body; an output port in fluid communication with the fluid reservoir; a fluid channel defining fluid communication between the one or more input ports and the output port; one or more biosensors, the one or more biosensors positionable in one or more of the catheter, the fluid channel, and the fluid reservoir, the biosensors in communication with a computing device to continuously measure biosignal data of a user's bodily fluid; A mobile monitoring device comprising:

2. The mobile surveillance device of claim 1 , wherein the output port is parallel to the one or more input ports.

3. The mobile monitoring device of claim 1 , wherein the computing device is for determining a state of the user based at least in part on the vital sign data.

4. 3. The mobile monitoring device of claim 1 or 2, wherein the one or more biosensors include one or more impedance sensors for detecting the impedance or conductivity of the fluid in the fluid channel.

5. 5. A mobile monitoring device according to claim 1, wherein the one or more biosensors include one or more biosensors for detecting a pH level in the fluid in the fluid channel.

6. The mobile monitoring device of claim 1 , wherein the one or more biosensors include at least one of a lactate sensor, an amylase sensor, a urea sensor, or a creatinine sensor.

7. 7. A mobile monitoring device according to claim 1, wherein the one or more biosensors are one or more flow sensors for continuously determining the flow rate of the fluid in the fluid channel over time.

8. 8. A mobile monitoring device according to claim 1, wherein the one or more biosensors are one or more light-based sensors including an optical transmitter and an optical receiver for detecting transmission of light through the fluid in the fluid channel.

9. The mobile monitoring device of claim 8 , wherein the one or more light-based sensors are configured to detect a color of the fluid based at least in part on a detected wavelength.

10. A mobile monitoring device according to any one of claims 1 to 9, further comprising one or more temperature sensors for detecting the temperature of the fluid in the fluid channel.

11. A mobile monitoring device according to any one of claims 1 to 10, wherein the one or more biosensors are positioned along the length of the fluid channel.

12. A computer-implemented method for monitoring a user's biological fluids with a mobile monitoring device, comprising: The mobile monitoring device comprises: one or more input ports attachable to one or more catheters inserted into a user's body, the input ports in fluid communication with the catheters for receiving fluid from the user's body; an output port in fluid communication with the fluid reservoir; a fluid channel defining fluid communication between the one or more input ports and the output port; one or more biosensors, the one or more biosensors positionable in one or more of the catheter, the fluid channel, and the fluid reservoir; a computing device; The method comprises: continuously measuring biosignal data of the biofluid by the mobile monitoring device; receiving, by the mobile monitoring device, the vital sign data continuously in near real-time from the one or more biosensors; determining, by the computing device, a state of the user based at least in part on the biosignal data; predicting, by the computing device, a future occurrence of a complication based at least in part on a condition of the user; A computer-implemented method comprising:

13. Receiving, by the computing device, a profile of the user, the profile of the user including at least one of information regarding a surgical procedure performed on the user, a date and time of the surgical procedure, a location of the surgical procedure, a date and time of insertion of the biosensor, a location of insertion of the biosensor, the user's age, height, weight, medical history, condition or illness, current or past medications used by the user, and current or past factors related to the user or details of the biosensor; determining, by the computing device, a condition of the user or predicting the future occurrence of the complication based at least in part on the profile of the user; 13. The computer-implemented method of claim 12, further comprising:

14. The computer-implemented method of claim 13, further comprising updating, by the computing device, the profile of the user based at least in part on the biosignal data.

15. The method of claim 1, further comprising: receiving, by the computing device, continuous flow data from a flow sensor in fluid communication with fluid from a user's body; and determining, by the computing device, a flow rate of the fluid based at least in part on the flow rate data; 15. The computer-implemented method of claim 12, wherein the user's condition is determined based at least in part on the flow rate.

16. The computer-implemented method of claim 15, further comprising determining, by the computing device, a rate of change of the flow rate of the fluid over time and a rate of change of the biosignal data over time, wherein predicting the future occurrence is based at least in part on the rate of change of the flow rate and the rate of change of the biosignal data.

17. 17. A computer-implemented method according to claim 15 or 16, wherein the flow data is received in near real-time.

18. A computer-implemented method as described in any one of claims 12 to 17, further comprising the step of receiving, by the computing device, optical data relating to the transmission of light through the fluid from an optical-based sensor in fluid communication with the fluid.

19. The computer-implemented method of claim 18, further comprising the step of determining, by the computing device, a color of the fluid based at least in part on the optical data.

20. A computer-implemented method as described in any one of claims 12 to 19, further comprising the step of receiving, by the computing device, temperature data of the fluid from a temperature sensor in fluid communication with the fluid.

21. The computer-implemented method of claim 20, further comprising modulating, by the computing device, the biosignal data based at least in part on the temperature data, flow data, impedance data, or conductivity data.

22. A computer-implemented method described in any one of claims 12 to 21, further comprising a step by the computing device of determining the user's risk factors based on cross-correlation with trends in biosignal data of other users.

23. 23. The computer-implemented method of claim 12, wherein the condition of the user is based at least in part on determining whether the vital sign data is within a threshold range.

24. A processor; A memory in communication with the processor storing instructions that, when executed by the processor, cause the processor to perform a computer-implemented method according to any one of claims 12 to 23. A system for monitoring a biological fluid of a user, comprising:

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