Sensor monitoring system for indwelling catheter based therapy

Abstract

The invention relates to a sensor monitoring system for indwelling catheter based therapy. A patient monitoring system may be used with a catheter to monitor injection and expulsion of any solution into the human body. The system may be used with, for example, indwelling catheters, urethral catheters, insulin pumps for diabetic patients, feeding tubes, and central venous catheters for peritoneal dialysis in end-stage nephropathy (ESRD) patients. The patient monitoring system includes one or more fluid paths for infusing solution into and / or draining solution from a catheter, and one or more sensors that monitor the fluid. The patient monitoring system transmits patient monitoring data to a database that allows patients and health care providers to store, process, and access data through a graphical user interface via a device application or browser-based network access portal.

Description

[0001] This application is a divisional application of the patent application with application number 201880089421.2. The application date of the original application is December 14, 2018, and the name of the invention is "Sensor monitoring system for indwelling catheter-based treatment".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 599,619, filed on December 15, 2017, and U.S. Provisional Application Serial No. 62 / 731,339, filed on September 14, 2018, the entire contents of each of which are incorporated herein by reference. Background Art

[0004] A variety of chronic diseases rely on patients to self-administer or family caregivers administer outpatient treatments, including injecting fluids into the body and / or draining fluids from the body via a catheter or tube. Examples of these treatments include, but are not limited to, permanent indwelling catheters for peritoneal dialysis for patients with end-stage renal disease, urinary catheters, catheters used with insulin pumps in diabetic patients, permanent or temporary feeding tubes, ascites drainage catheters, hydrocephalus drainage catheters, and various central venous catheter delivery treatment applications. For treatments with optional central treatments, such as hemodialysis for peritoneal dialysis, CMS recently shifted from a fee-for-service model to a value-based bundled payment system structure, which resulted in financial incentives for health care providers to treat as many of their patients as possible via outpatient treatments to avoid the high costs associated with central treatments. In those outpatient treatments, high indirect costs are transferred to health care providers, such as compliance insurance and hospitalization insurance related to infection. For example, in the case of peritoneal dialysis (PD), dialysis health care providers pay more than $200 million in salaries for outpatient PD nurses each year, and more than $1 billion for hospitalization insurance related to infection each year. Currently, patients undergo dialysis checkups on average 1-3 times per month, with the primary purpose of the checkups being visual inspection for primary infection, compliance via patient-recorded data or computer memory cards with data collected by night cyclers for continuous cycling peritoneal dialysis patients, and blood draws to monitor treatment effectiveness. Therefore, additional devices, systems, and methods for monitoring patient complications such as infection, catheter occlusion, and ultrafiltration failure may be needed. Summary of the invention

[0005] A sensor monitoring system is provided that can be used with an existing catheter to monitor the injection and discharge of any solution into the human body. The system can be used with, for example, peritoneal dialysis catheters, urinary catheters, hydrocephalus shunts, ascites drainage catheters, insulin pumps for diabetics, feeding tubes, central venous catheters, etc. for patients with end-stage renal disease (ESRD). The sensor monitoring system includes one or more fluid paths for infusing solutions into the catheter and / or draining solutions from the catheter, and one or more sensors for monitoring fluids and / or patients (e.g., in areas near the catheter exit site). The sensor monitoring system transmits patient monitoring data to a database that, for example, enables patients and health care providers to store, process, and / or access data via a graphical user interface via a device application or a browser-based web access portal.

[0006] A variation of the system includes an apparatus and method for monitoring dialysis treatment related to: a) patient compliance with a prescribed dialysis treatment; b) dialysate solution ultrafiltration (UF) effectiveness; and / or c) complications associated with dialysis, such as infection and / or catheter occlusion. The system provides a sensor array having a plurality of sensing mechanisms housed in a housing and fluidly connected to the dialysate solution. One or more patient parameters or signals are monitored, and in some variations, different signals and / or combinations of signals that vary over time are generated from the sensor array and reported or analyzed to determine patient status.

[0007] As described in further detail below, the system can be used as a first line of defense for health care providers in an ambulatory or home-based environment to continuously monitor for early signs of complications, including but not limited to infection, catheter leaks, and catheter obstructions. Patient compliance with prescribed therapy can be tracked and communicated to the patient and / or health care provider, and the adequacy / effectiveness of treatment can also be assessed to indicate whether the body is responding to treatment. These systems can allow for an increase in the number of patients assigned to each health care provider and can reduce the number of clinic visits, which can provide a substantial cost reduction value proposition for reducing outpatient management costs. In addition, early infection detection can be informed of the onset of infection at a stage where it can be treated with antibiotics rather than escalated to hospitalization. When antibiotic treatment is initiated, the effectiveness of antibiotic treatment can also be monitored by the system.

[0008] One or more patient parameters can be wirelessly transmitted to a database for storing and processing data by a security protocol. The user interface of the patient allows retrieval of database information and other inputs from the patient stored in the database. The user interface of the health care provider allows remote monitoring of one or more patients by displaying a visual interface and an alarm system for the monitored data, and the user interface can, for example, provide deviations (such as reduced analyte levels, reduced patient physical activity, reduced pH values, increased core body temperature) and / or clinical outcome diagnoses (such as patient infection, catheter leakage, catheter obstruction, patient non-compliance with treatment, reduced therapeutic effects, etc.) of the monitoring data of the patient. The user interface of the health care provider can also allow input of patient vital sign measurements, test results, and clinical events (such as acute infection) to track the history of patient care, and provide data for regression analysis, such as the correlation of sensor-based data with infectious complications.

[0009] In one variation, the system monitors patients with end-stage renal disease who are prescribed peritoneal dialysis. In this variation, the patient monitoring device includes a flow sensor connected to the patient's dialysis catheter. The flow sensor can be used to measure the filling volume / filling volume (FV) of the infused dialysate solution infused through the catheter and / or the drainage volume / drainage volume (DV) of the discarded dialysate leaving the catheter to determine the FV / DV ratio. When only the DV measurement result is measured from the sensor, the patient or health care provider can enter the specified FV value, so the FV / DV ratio can also be calculated. After the initial ultrafiltration (UF) stabilization period, the patient's FV / DV ratio baseline value (e.g., mean, median, range, standard deviation) is determined, and related indicators with ultrafiltration effect are provided. When monitoring the patient, the deviation of the FV / DV ratio relative to the baseline exceeds a given level (e.g., exceeds one standard deviation) and an alarm is issued to the health care provider. The health care provider can then log into a browser-based portal or other software to view recent data in the context of historical data and adjust dialysate therapy (e.g., type of dialysate, infusion volume, and number of daily cycles) or potentially switch the patient to hemodialysis therapy if the patient's UF levels become low, making them medically unsuitable for peritoneal dialysis therapy.

[0010] In another example for peritoneal dialysis patients, where a patient monitoring device is connected to the patient's dialysis catheter, a combination of one or more of a temperature sensor, a light scattering / absorption sensor for the fluid, a conductivity sensor, a flow sensor, and a pH sensor can be used to detect patient infection. A variety of sensors can detect a variety of biological expressions of infection. Various sensor measurements can be used to issue an alert to a health care provider about a potential infection. For example, an alert may be caused by an increase in the temperature of the drained dialysate solution exceeding a standard biological range, an increase in the light scattering / absorption of the drained dialysate solution (normalized or not normalized to the drainage volume or dwell time data from the flow sensor) relative to a baseline value, an increase in the pH of the drained dialysate solution relative to a baseline value, and / or a change in the conductivity and / or FV / DV ratio of the drained dialysate solution. In some variations, a health care provider can log into a browser-based web portal to view recent data in the context of historical data, initiate infection treatment, and monitor the adequacy of treatment.

[0011] For patients undergoing peritoneal dialysis, the system can utilize a variety of sensors, including but not limited to flow sensors, temperature sensors, light scattering / absorption sensors, pressure sensors, pH sensors, conductivity sensors, accelerometers, and gyroscopes to provide remote monitoring of a) complications associated with dialysis (e.g., peritonitis, catheter blockage, catheter leak, hernia development), b) patient compliance with prescribed dialysis therapy, and c) ultrafiltration adequacy of dialysis therapy. Remote monitoring provides more cost-effective and convenient dialysis treatment for health care providers and patients.

[0012] Another potential benefit of a monitoring system is that health care providers are able to monitor patients more frequently than is actually possible through in-person clinic visits alone. Frequent monitoring of patients allows health care providers to immediately address complications and / or poor treatment outcomes before the problem worsens. For example, when an infection is detected early, the infection can be treated with antibiotics, which are more effective in the early stages of the infection, thus preventing the patient from being hospitalized when it is discovered later. The infection can be monitored after antibiotic treatment has been initiated. In another example, when treatment outcomes are poor, the prescribed medication treatment (e.g., medication, dosage, frequency) can be updated immediately.

[0013] Another potential benefit of monitoring systems is providing health care providers with additional data for diagnosing complications and determining the best course of treatment. The current standard of care typically relies on the patient's visual appearance, blood tests, and vital signs. The data provided by monitoring systems can supplement traditional data sets, provide more insights into the patient's status, and take into account the patient's historical (e.g., baseline) status. The system can also synthesize data over time in a way that allows data trends to be visualized.

[0014] It should be understood that the system and method can be used in a variety of different dialysis therapies to treat renal failure. Dialysis therapy can include and encompass any and all forms of therapy utilizing fluid (e.g., patient's blood, dialysate) to remove waste, toxins, and excess water from a patient. This therapy, for example, includes hemodialysis, hemofiltration, hemodiafiltration, and peritoneal dialysis, including automated peritoneal dialysis, continuous ambulatory peritoneal dialysis, and continuous flow peritoneal dialysis. Where applicable, this therapy can also include intermittent therapy and continuous therapy for continuous renal replacement therapy. The patient receiving dialysis therapy treatment can include a patient suffering from chronic renal failure and a patient suffering from acute renal failure, whether the renal failure is caused by kidney disease or non-renal disease.

[0015] In one variation, a method for detecting an infection in a patient includes the steps of receiving a bodily fluid from the patient through a fluid conduit; measuring an optical property of the bodily fluid from the patient in two or more wavelength ranges; estimating a white blood cell concentration based at least in part on the optical property measurements in the two or more wavelength ranges, and detecting an infection state of the patient based at least in part on the estimated white blood cell concentration.

[0016] In some variations, the optical property includes one or more of light scattering and absorption. In some variations, measuring the optical property within a first wavelength range may correspond to a total particle concentration of a patient's bodily fluid, and measuring the optical property within a second wavelength range may correspond to a leukocyte concentration of the patient's bodily fluid. The first wavelength range may be different from the second wavelength range. In some variations, the first wavelength range is between about 700 nm and about 1 mm, and the second wavelength range is between about 260 nm and about 550 nm.

[0017] In some variations, measuring the optical property within a first wavelength range corresponds to a total particle concentration of the patient fluid and measuring the optical property within a second wavelength range corresponds to a non-leukocyte particle concentration of the patient fluid. The first wavelength range may be different than the second wavelength range. In some variations, a sensor may be used to measure the homogeneity of the patient fluid. Based at least in part on the measured homogeneity, a set of optical property measurements may be excluded from the leukocyte concentration estimate.

[0018] In some variations, dialysate may be received via a fluid conduit. A sensor may be used to measure an optical property of the dialysate. The dialysate may be infused into a patient, and patient fluid may be removed from the patient. An estimated leukocyte concentration may be based at least in part on the optical property measurement of the dialysate. In some variations, an optical property difference between the patient fluid and the dialysate may be estimated. An infection status of the patient may be updated based at least in part on the optical property difference.

[0019] In some variations, a flow sensor connected to a fluid conduit can be used to measure one or more of the flow rate and total flow of a patient's body fluid. The optical property measurement results can be normalized based on one or more of the flow rate and total flow measurement results. In some of these variations, one or more of the obstruction and flow direction can be detected based at least in part on the flow rate measurement results. In some of these changes, one or more of the infusion volume, drainage volume, infusion time, drainage time, and retention time can be estimated based at least in part on the flow rate measurement results. One or more of the dialysis efficiency and dialysis adequacy can be estimated based at least in part on the estimated infusion volume, drainage volume, and retention time. In some variations, one or more of the infusion state, retention state, and drainage state of the patient's body fluid can be detected without user input.

[0020] In some embodiments, the method may include one or more of the following steps: measuring the pH of a patient's bodily fluid using a pH sensor, wherein the detected infection state is based at least in part on the measurement of the pH; measuring the lactate concentration of a patient's bodily fluid using a lactate sensor, wherein the detected infection state is based at least in part on the measurement of the lactate concentration; counting cells in the patient's bodily fluid using a cell counter, wherein the detected infection state is based at least in part on the number of cells; measuring leukocyte esterase in the patient's bodily fluid using a test strip, wherein the detected infection state is based at least in part on the measurement of the leukocyte esterase; measuring chemiluminescence of the patient's bodily fluid using a chemiluminescence sensor, wherein the detected infection state is based at least in part on the measurement of the chemiluminescence; using an image sensor The method comprises the steps of: measuring the color of the patient's skin using a conductivity sensor, wherein the detected infection status is based at least in part on the color measurement result; measuring the conductivity of the patient's body fluid using a conductivity sensor, and estimating the solute concentration of the patient's body fluid based at least in part on the conductivity measurement result; measuring urea of ​​the patient's body fluid using an electrochemical sensor, and estimating the urea concentration of the patient's body fluid based at least in part on at least one of the conductivity and flow rate measurement results and the urea measurement result; measuring creatinine of the patient's body fluid using an electrochemical sensor, and estimating the creatinine concentration of the patient's body fluid based at least in part on the creatinine measurement result and the flow measurement result; and measuring glucose of the patient's body fluid using a glucose sensor, and estimating the glucose concentration of the patient's body fluid based at least in part on at least one of the conductivity and flow measurement results and the glucose measurement result.

[0021] In some variations, at least one alarm may be output that includes one or more of a patient's infection status, patient compliance with prescribed therapy, treatment effectiveness, sensor calibration, fluid conduit maintenance, and sensor data. In some of these variations, the alarm sensitivity may be modified based on one or more of a set of patient clinical events and a patient profile.

[0022] In some variations, in response to detecting a positive infection state of a patient, a prompt may be output to enter patient data. The entered patient data may be received. The detected infection state may be classified as a false positive based at least in part on the entered patient data. In some variations, an alarm corresponding to a fluid conduit obstruction may be output based at least in part on pressure measurements and acceleration measurements. In some variations, the infection state of the patient may be transmitted to a health care provider. A prescription for a therapeutic agent may be received from the health care provider. The therapeutic agent may be dispensed without user input.

[0023] In some variations, a sample of a patient's bodily fluid may be collected in a sample container removably coupled to a fluid conduit based at least in part on a detected infection status of the patient. The sample container may be detachable from the fluid conduit. In some variations, a sample container alert may be output to one or more of a patient, a health care provider, and a delivery service personnel based at least in part on the infection status and the location of the sample container. In some variations, a sensor may be coupled between a drainage line and a drainage container, or a sensor may be coupled between an infusion line and an infusion dialysate container.

[0024] In some variations, a patient monitoring device may include an optical sensor device including at least one emitter and at least one detector. The emitter may be configured to transmit light within one or more wavelength ranges through a patient's bodily fluid flowing through a fluid conduit. At least one detector may be configured to receive light transmitted through the patient's bodily fluid and generate signal data based on the received light. The controller may be configured to use the signal data to estimate total particle concentration and leukocyte concentration. In some variations, the device may include a housing surrounding the optical sensor device. The fluid conduit may be configured to be removably coupled to the housing. In some of these variations, the housing may be configured to transition between an open configuration having an exposed internal cavity and a closed configuration having an enclosed internal cavity.

[0025] In some variations, the at least one non-fluid contact sensor comprises one or more of a pressure sensor, an image sensor, an accelerometer, a gyroscope, a temperature sensor, and a magnetic field sensor. In some variations, the fluid conduit comprises at least one transparent portion that is substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. In some variations, the fluid pathway comprises an inlet and an outlet, the inlet being configured to couple to at least one of an indwelling catheter and a drain line for peritoneal dialysis, the outlet being configured to lead to a drain container.

[0026] In some variations, one or more portions of the fluid conduit may be composed of one or more of acrylic resin, polycarbonate, cyclic olefin copolymer (COC), polystyrene, acrylonitrile-butadiene-styrene (ABS), polysiloxane coated with polyethylene glycol, polyurethane coated with zwitterions, polyvinyl chloride coated with polyethylene oxide, and amphiphilic polysiloxane. In some of these variations, the fluid conduit is a first fluid conduit from which a second fluid conduit with a closed end branches out. The flow sensor may also be configured to measure the fluid level / liquid level of the second fluid conduit. In some variations, the fluid conduit may include a ball and a flow sensor configured to measure the ball. In some variations, the fluid conduit may include at least one fluid contact sensor, including one or more of a flow sensor, a conductivity sensor, a temperature sensor, a pH sensor, a lactate sensor, a test strip, a chemiluminescent sensor, an electrochemical sensor, and a glucose sensor. In some variations, one or more portions of the fluid conduit are composed of materials that are sensitive to bacterial contamination / scaling. In some variations, the mounting member may be configured to removably attach the housing to the drainage container.

[0027] In some variations, the housing may include a therapeutic agent container configured to store a therapeutic agent. The controller may be configured to receive a prescription from a health care provider and release the therapeutic agent based on the received prescription. Releasing the therapeutic agent may include unlocking the therapeutic agent container and dispensing the therapeutic agent into one or more of the fluid conduit. In some variations, the controller may be configured to open the valve to fill the sample container with the patient's bodily fluid when a positive infection state of the patient is detected. In some variations, the mounting member may include an adhesive layer including one or more of a silicone adhesive and an acrylate adhesive. In some variations, one or more of a temperature sensor and a skin color sensor may be located at the mounting surface.

[0028] In some variations, the patient monitoring device may include a housing configured to removably engage a fluid conduit. At least one sensor may be configured to measure at least one characteristic of a fluid flowing through the fluid conduit. The controller may be configured to generate patient data including an infection status of the patient based at least in part on at least one characteristic. In some of these variations, the characteristic may include one or more of light scattering, absorption, color, flow rate, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration.

[0029] In some variations, the housing may include a hinge and the housing is configured to surround at least a portion of the fluid conduit. In some variations, the fluid conduit may include a hard curved end configured to removably attach the fluid conduit to the drainage container so that the housing is separated from the drainage container. In some variations, at least one sensor is configured to be clamped on a portion of the fluid conduit that allows at least one of ultraviolet light, visible light, and infrared radiation to pass through. In some variations, at least one sensor is a fluid contact sensor. In some variations, the device may include a limited use sensor configured to removably engage one or more of the fluid conduit and the housing. In some of these variations, the controller may be configured to detect whether the limited use sensor has expired based at least in part on the measured flow rate.

[0030] In some variations, the fluid conduit may be coupled to one or more of an indwelling catheter for peritoneal dialysis, a urinary catheter, a hydrocephalus shunt, a percutaneous abscess drainage catheter, an ascites drainage catheter, an insulin pump, a feeding tube, a central venous catheter, a tunneled catheter, and an implanted access port. In some variations, the docking station may include at least one fluid chamber, a pump coupled to the at least one fluid chamber, a fluid port coupled to the at least one fluid chamber, an engagement structure that may be mated with a patient monitoring device, an engagement sensor configured to generate a sensor signal when the engagement structure is mated with the patient monitoring device, and a controller configured to circulate fluid through the patient monitoring device using the fluid pump based at least in part on the sensor signal.

[0031] In some variations, the fluid is circulated at one or more of a predetermined flow rate, conductivity, light scattering, absorption, and temperature, and the controller is configured to use the circulating fluid to calibrate at least one sensor of a patient monitoring device. In some variations, the at least one fluid chamber includes a first chamber and a second chamber, and the first chamber is separated from the second chamber fluid. In some variations, the docking station includes an ultraviolet (UV) light source that is configured to optically connect to a fluid conduit of the patient monitoring device. The controller can be configured to emit ultraviolet light into the fluid conduit using the UV light source. In some variations, the engagement structure can include a fluid connector and an electrical connector. The fluid connector can be configured to be fitted with a fluid conduit of a patient monitoring device. The electrical connector can be configured to be fitted with one or both of an electronic communication device and a power supply of the patient monitoring device.

[0032] In some variations, the at least one sensor may include one or more of a flow sensor, a conductivity sensor, an image sensor, a pressure sensor, an accelerometer, and a magnetic field sensor. In some variations, the controller may be configured to receive, store, and transmit one or more of sensor data, calibration data, patient data, and device data of the patient monitoring device. In some variations, the docking station may include a battery charging port configured to power a battery of the patient monitoring device.

[0033] In some variations, a method of monitoring a patient for infection may include the steps of measuring at least one characteristic of a patient's bodily fluid during a first time period and a second time period following the first time period. The at least one characteristic may include one or more of light scattering, light absorption, flow rate, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration. Patient data including a baseline range for the at least one characteristic may be generated during the first time period. The patient's state may be monitored during the second time period based at least in part on the baseline range and the measured characteristic.

[0034] In some variations, a set of patient clinical events may be measured during a first time period and a second time period subsequent to the first time period. A relationship between the set of patient clinical events and at least one characteristic may be estimated during the first time period. The patient state may be monitored during the second time period based at least in part on the estimated relationship and the measured characteristic. In some variations, an alert may be output to a predetermined contact when the measured characteristic deviates from a baseline range during the second time period.

[0035] In some variations, the alarm sensitivity may be modified based on one or both of a certain number of deviations from a baseline range and a certain number of patient clinical events. In some variations, the patient status may include one or more of the patient's infection status, the patient's compliance with prescribed therapy, treatment effectiveness, device maintenance, sensor calibration, and sensor data. In some variations, in response to an alarm corresponding to the patient being in a high-risk condition, a communication channel may be established between the patient and a health care professional. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1A Exemplary variations of monitoring systems are schematically shown.

[0037] Figure 1B Another exemplary variation of a monitoring system is schematically shown.

[0038] Figure 2 An exemplary variation of a patient monitoring device is schematically shown, depicting the layout of the patient monitoring device and the connections to an indwelling catheter and dialysate.

[0039] Figure 3 Top and side views of exemplary variations of patient monitoring device housings and components are shown.

[0040] Figure 4 A cut-away top view of another exemplary variation of a patient monitoring device housing and components is shown.

[0041] Figure 5 An assembly diagram of an exemplary variation of a patient monitoring device constructed from disposable and permanent components is shown.

[0042] Figures 6A-6D 7A-7D show various exemplary patient monitoring devices and disposable component configurations. In particular, Fig. 6A , 6C 7A and 7C are schematic top views. Figure 6B , 6D , 7B and 7D are schematic cross-sectional views.

[0043] Fig. 8A A perspective view of an exemplary variation of a disposable component of a patient monitoring device coupled to a fluid conduit is shown. Figure 8B and 8C yes Fig. 8A Schematic top view of disposable components and fluid conduits shown.

[0044] Figures 9A-9D Schematic perspective views showing exemplary variations of a removable disposable component in different states.

[0045] Figures 10A-10C A top view of an exemplary variation of an optical sensor system is shown. Fig. 10A A top view of the sensor system is shown. Fig. 10B Variations of sensor systems that include fluid conduits are shown. Fig. 10C A variation of an optical reader that clamps onto a fluid conduit is shown.

[0046] Fig.11A and 11B Side and perspective views, respectively, are shown of an exemplary variation of a patient monitoring device configured to clamp onto a fluid conduit.

[0047] Fig.12 An exemplary variation of a patient monitoring system is shown that includes a patient monitoring device coupled to a drain container.

[0048] Fig.13 An exemplary variation of a patient monitoring system is shown that includes a patient monitoring device coupled to an indwelling catheter and a connector tube.

[0049] Fig.14An exemplary variation of a patient monitoring system is shown that includes a set of patient monitoring devices connected to a connector tube and to a solution container and a drainage container, respectively.

[0050] Fig.15 An exemplary variation of a patient monitoring system is shown that includes a patient monitoring device coupled to a connector tube and a drainage container.

[0051] Fig.16A Plan views of exemplary variations of fluid conduits are shown. Fig. 16B is a plan view of an exemplary variation of a PCB interface. Fig. 16C yes Fig.16A and 16B Plan views of exemplary variations of fluid conduit and PCB interfaces are shown. Fig.16D is a top view of an exemplary variation of a fluid conduit and a patient monitoring device. Fig.16E yes Fig.16D A side cross-sectional view of an exemplary variation of a fluid conduit and patient monitoring device is shown.

[0052] Fig.17 A perspective view of an exemplary variation of a fluid conduit is shown.

[0053] Fig.18 Exemplary variations of inlets and outlets for patient monitoring devices are shown.

[0054] Fig.19 An exemplary variation of a patient monitoring system is shown that includes a patient monitoring device coupled to an indwelling catheter.

[0055] Fig. 20A and 20B Shown are side and perspective views, respectively, of an exemplary variation of a patient monitoring device configured to clamp onto a fluid conduit, such as a connector tube.

[0056] Fig.21A , 21B 21C illustrate side and perspective views, respectively, of another exemplary variation of a patient monitoring device configured to clamp onto a connector tube.

[0057] Fig. 22 A side view of an exemplary variation of a patient monitoring device is shown.

[0058] Fig.23A and 23B A schematic perspective view of an exemplary variation of a patient monitoring device having a mounting structure is shown.

[0059] Fig.24A and 24BA perspective view of an exemplary variation of a patient monitoring device attached to a toilet is shown.

[0060] Fig.25A and 25B A perspective view showing an exemplary variation of a tube connection set is shown.

[0061] Fig.26 A schematic diagram of an exemplary variation of a patient monitoring device including a set of fluid conduits and a set of one-way valves is shown.

[0062] Fig. 27 , 28 , 29, 30, 31 and 32 show schematic diagrams of exemplary variations of patient monitoring devices including fluid conduits and sensors.

[0063] Fig.33 A schematic circuit diagram of an exemplary variation of a thermistor is shown.

[0064] Fig.34 Schematic circuit diagrams of exemplary variations of infrared light scattering and / or absorption sensors are shown.

[0065] Fig.35 Exemplary variations of the absorption spectra of components of the effluent are shown.

[0066] Fig.36 Exemplary variations of graphs of cell concentration and voltage output from light scatter and / or absorption sensors are shown.

[0067] Fig.37 Exemplary graphs of cell concentration and signal ratio are shown.

[0068] Fig.38A and 38B Exemplary graphs of cell concentration and signal output from a two-stage light scattering and / or absorption system are shown, where the second stage uses a different wavelength range.

[0069] Fig.39A and 39B Other exemplary graphs of cell concentration and signal output from a two-stage light scattering and / or absorption system are shown, where the first and second stages use different wavelength ranges.

[0070] Fig.40A An exemplary graph showing uniform light scattering / absorption is shown. Fig.40B is an image of particles uniformly mixed in a solution.

[0071] Fig.41A An exemplary graph of non-uniform light scattering / absorption is shown. Fig.41B is an image of inhomogeneous particles suspended in a solution.

[0072] Fig.42A An exemplary graph of large particle flow versus time is shown. Fig.42B is an image of a strip (eg, fibrin) in a fluid conduit.

[0073] Fig.43 Schematic cross-sectional views of exemplary variations of light scattering and / or absorption sensors are shown.

[0074] Fig.44 A schematic diagram showing an exemplary variation of a forward optical system is shown.

[0075] Fig.45 A schematic circuit diagram of an exemplary variation of a pressure sensor arrangement is shown.

[0076] Fig.46 A schematic circuit diagram of an exemplary variant of a conductivity sensor is shown.

[0077] Fig.47A A perspective view of an exemplary variation of a docking station is shown. Fig.47B A perspective view of an exemplary variation of a patient monitoring device coupled to a docking station is shown.

[0078] Fig.48A Schematic diagrams of exemplary variations of docking stations are shown. Fig.48B Shows Fig.48A A perspective view of a docking station is shown. Fig.48C and 48D Shows Fig.48B A perspective view of an exemplary connector of a docking station is shown.

[0079] Fig.49 An exemplary calibration process using flow monitoring is shown.

[0080] Fig.50 An exemplary method for determining the flow state of a surrogate solution is shown.

[0081] Fig.51 An exemplary method for generating an alert of a change in ultrafiltration effectiveness is shown.

[0082] Fig.52 An exemplary method for generating an alert based on pressure data is shown.

[0083] Fig.53 An exemplary method for generating an alert for infection detection is shown.

[0084] Fig.54A and 54B Schematic cross-sectional views of exemplary variations of sample containers coupled to fluid conduits are shown.

[0085] Fig.55A, 55B 55C show schematic cross-sectional views of another exemplary variation of a sample container coupled to a fluid conduit.

[0086] Fig.56 An exemplary method for generating an alert to a group of stakeholders is shown.

[0087] Fig.57A , 57B , 57C, 58A, 58B and 58C illustrate exemplary methods for storing and accessing therapeutic agents.

[0088] Fig.59 An exemplary method of controlling alarm level sensitivity based on one or more patient vital measurements is shown.

[0089] Fig.60 An exemplary graphical user interface for patient monitoring by a healthcare provider is shown. Fig.61 An exemplary graphical user interface for patient monitoring is shown.

[0090] Fig.62 An exemplary variation of a patient monitoring system is shown that includes a patient monitoring device coupled to a urethral catheter.

[0091] Fig.63A , 63B and 63C show various views of an exemplary variation of a subcutaneous sensor variation device.

[0092] Fig.64A is a perspective view of an exemplary variation of a patient monitoring device. Fig.64B Attached to the toilet Fig.64A A perspective view of a patient monitoring device is shown.

[0093] Fig.65 is a perspective view of an exemplary variation of a durable component of a patient monitoring device.

[0094] Fig.66A and 66B is a perspective view of an exemplary variation of a disposable component of a patient monitoring device. Fig.66C is a perspective view of an exemplary variation of a disposable fluid conduit for a patient monitoring device. Fig.66D yes Figures 66A-66C A perspective view of the disposable components and disposable fluid conduits are shown. Fig.66E is an exploded perspective view of a patient monitoring device. Fig.66F is an assembled perspective view of a patient monitoring device.

[0095] Fig.67A and 67B is a perspective view of an exemplary variation of a patient monitoring device attached to a toilet.

[0096] Fig.68A , 68B , 68C and 68D are perspective views of exemplary variations of patient monitoring devices.

[0097] Fig.69A , 69B , 69C and 69D are perspective views of exemplary variations of durable components of a patient monitoring device.

[0098] Fig.70A and 70B is a perspective view of an exemplary variation of a fluid conduit for a patient monitoring device.

[0099] Fig.71A is a perspective view of an exemplary variation of a patient monitoring device. Fig.71B is a perspective view of an exemplary variation of the mounting structure. Fig.71C and 71D yes Fig.71A and 71B A perspective view of a patient monitoring device and mounting structure is shown.

[0100] Fig.72 and 73 An exemplary graphical user interface for patient monitoring is shown.

[0101] Fig.74 is a perspective view of an exemplary variation of a fluid conduit of a patient monitoring device including a spherical flow sensor.

[0102] Fig.75A and 75B is a detailed side view of an exemplary variation of a spherical flow sensor for a fluid conduit.

[0103] Fig.76A and 76B is a detailed side view of another exemplary variation of a ball valve for a fluid conduit.

[0104] Fig.77 is a schematic cross-sectional side view of another exemplary variation of a fluid conduit of a patient monitoring device.

[0105] Fig.78A , 78B 78C and 78D are schematic cross-sectional side views of exemplary variations of optical sensor and fluid conduit configurations for patient monitoring devices. DETAILED DESCRIPTION

[0106] Various examples herein relate to patient data related to the delivery of a solution to and / or discharge from the human body via a catheter to monitor various therapies. The system described herein may include a patient monitoring device having one or more sensors connected between, on and / or within the patient's catheter, connector tube and the solution delivered and / or the solution discharged. The patient monitoring device collects and can process sensor data. The system may include an integrated or stand-alone transmitter to receive patient monitoring device data and send it to one or more computing devices, such as mobile devices and database servers. The system may include a database server that receives and / or processes data. The system may include a user interface that receives data from a database server, visually aggregates data, provides an alarm to one or more stakeholders (such as users, health care providers, family members, partners, caregivers) and / or allows a user to input additional monitoring data.

[0107] In one method of use, the system monitors patient compliance with prescribed therapy, patient complications, and / or treatment effectiveness. Initially, a health care provider can establish a patient in the monitoring system by entering information via one or more applications on one or more computing devices, mobile devices, tablet devices, and / or browser-based web access portals. Information input can include an assigned patient monitoring device identification number, an assigned transmitting computing device identification number, patient name, date of birth, initial vital signs (e.g., blood pressure, temperature, weight, oxygenation level, etc.), and / or details of prescribed therapy, including medication type, dosage, and duration of each use cycle.

[0108] The patient can connect the patient monitoring device to its catheter or connector tube. The patient can prepare the patient monitoring device by first assembling the disposable parts of the housing to the durable parts of the patient monitoring device. Then, the patient can charge the patient monitoring device by plugging the micro USB cable into the micro USB port of the power supply and the patient monitoring device. Additionally or alternatively, the patient monitoring device can be plugged into a docking station, which can be configured to charge the battery of the patient monitoring device, upload / download data to the memory of the patient monitoring device, clean and / or disinfect one or more parts of the patient monitoring device (e.g., contact sensors, fluid conduits), and / or calibrate the patient monitoring device. In order to activate the system, the patient can press and hold the switch to turn on the system, and the LED light on the patient monitoring device indicates that the system is turned on. By pressing and holding the switch on the patient monitoring device until the blue and red LED lights flash, opening the only application for the system on the computing device, finding the patient monitoring device on the computing device application and entering the provided unique code (e.g., PIN, password, identifier), the patient can pair the patient monitoring device with an independent computing device (e.g., tablet computer, smartphone) via a Bluetooth connection. When communication is established and the patient monitoring device is authenticated, the application confirms the patient's connection of the patient monitoring device to the catheter through a pop-up message.

[0109] In some variations, the patient monitoring device can be attached to a drainage container (e.g., a drainage basin, toilet, sink, bathtub, waste bag, etc.) via a clamp holder, hook, clamp, strap, adhesive, or other suitable mounting structure and / or device. Alternatively, the patient can attach the patient monitoring device to his abdomen or other skin surface next to his catheter (e.g., after removing the release layer from the adhesive backing / base fabric and attaching via the adhesive backing / base fabric). The patient can flush the patient monitoring device tube with sterile saline by connecting a syringe filled with saline to the inlet tube port and injecting saline until all the air is flushed out. The patient can connect the fluid connection fitting from the patient monitoring device to its catheter port or connector tube. The patient can remove the syringe from the inlet tube of the patient monitoring device.

[0110] For a prescribed duration, the patient may connect the opposing tubing fitting from the patient monitoring device to the line from the prescribed therapy (eg, a dialysis tubing port for a peritoneal dialysis patient, an intravenous medication tubing port for a PICC catheter treating an infection, etc.).

[0111] During the use of the device (e.g., at a frequency of about every 2-4 weeks), the patient may receive a push notification on the computing device tablet or a text message on their mobile device to maintain / repair the patient monitoring device. Repairs may require the patient to remove the patient monitoring device, remove disposable components of the housing (e.g., fluid conduits, cartridges), replace the disposable components of the housing with new disposable components, charge the patient monitoring device, remove the hardware module connector from the conduit or tube connector, and flush the fluid lines of the patient monitoring device with isopropyl alcohol for cleaning and disinfection.

[0112] In another variation, maintenance / repair of a patient monitoring device may include the use of a docking system (e.g., a docking station) to implement automated cleaning, disinfection, data transfer, charging, and / or calibration processes for the device. The docking system may be a stand-alone hardware device including inlet and outlet fluid conduits that may be configured to be in fluid communication with a fluid conduit of the patient monitoring device. At predetermined intervals, a user may separate the patient monitoring device from the conduit or tube connector and then connect the patient monitoring device to the connector of the docking system. After connection, the docking system may charge a power source and / or pump various fluids to clean and disinfect one or more components of the patient monitoring device. When connected, the docking system may calibrate a sensor with a fluid, such as calibrating one or more sensors (e.g., a spectral sensor, a light scattering / absorption sensor) with a cleaning fluid having known light scattering / absorption properties, and / or calibrating a temperature sensor with a fluid having a known temperature, and / or calibrating a flow sensor with a fluid pumped at a known flow rate, and / or calibrating a conductivity sensor with a fluid of known conductivity.

[0113] The patient monitoring device can transmit sensor data to one or more processing devices (e.g., computing devices) such as tablet computers, docking stations, mobile devices, etc. using a wireless protocol (e.g., Bluetooth). The processing device can receive and process the data and can further transmit the data to a server (e.g., a database) via a wired or wireless network connection. When a docking system is used, other communication methods can be used, such as a wired Ethernet connection or Wi-Fi. When communication using the patient monitoring device fails, redundant communication on the docking system can be used to transmit data.

[0114] In some variations, the patient may be provided access to their sensor data and / or analysis through a graphical user interface of a computing device (e.g., tablet, mobile phone, laptop, PC). The system may also allow the patient to enter other data into the user interface, such as weight, blood pressure, oxygen saturation, energy / fatigue level, health, fever, and pain. Some of these inputs may need to be entered at a prescribed frequency, and the patient may be prompted to enter data at these prescribed frequencies via push notifications and / or text messages.

[0115] In some variations, access to patient monitoring data can be provided to health care providers (e.g., health care professionals, care providers) through a graphical user interface on one or more computing devices (e.g., a browser-based web access portal). The health care provider can, for example, log in to the browser-based web access portal through a personal computer. The health care provider can view all monitoring data from one or more patients. The health care provider can also input laboratory test results, patient appointment records, patient treatment changes, patient infections and complications, and any other findings into the system.

[0116] The system can also provide an alarm to the patient and / or health care provider. An alarm can be issued to the patient to remind him to start the steps in his prescription therapy, or to warn the patient in the case of delaying or skipping the treatment of the prescription therapy. In addition, when there is an abnormality in the data, such as when potential complications (such as catheter obstruction, patient infection events) may occur, or when the patient skips their multi-dose treatment, an alarm can be generated to the patient and health care provider. In some variations, one or more alarms can be provided to the predetermined contact (such as family, partner, caregiver, health care provider) of the predetermined group based on predetermined criteria such as non-compliance or detected infection. The contact group can be selected by the patient or caregiver, and can receive an alarm or other communication by one or more of the push notifications on the phone, email, text message, mobile device, network portal, etc. In some variations, data communication can be started at predetermined intervals, such as during docking with the docking station and / or when an infection state is detected.

[0117] Patient Monitoring System Configuration

[0118] Figure 1A An exemplary variation of a monitoring system for a patient receiving peritoneal dialysis treatment is shown. The patient may have an indwelling patient catheter (12) that may be connected to a transfer tube set (T) that enables a solution (27) to be introduced into and dialyzed from the patient through the patient catheter (12), such as in a dialysate replacement. Typically, a patient monitoring device (00) may be fluidically connected to the indwelling patient catheter (12) (e.g., via a transfer tube set) to receive a dialysate solution (e.g., a discharged dialysate solution). For example, a patient monitoring device (00) may be connected in series with a drainage line (D), such as to receive dialysate from the patient and transfer it to a drainage container (e.g., a toilet). The patient monitoring device (00) may include one or more sensors to measure one or more parameters of the dialysate solution. Sensor data may be analyzed as described herein to monitor one or more patient conditions.

[0119] The patient monitoring device (00) may include a microcontroller that can control one or more sensors through firmware, receive signals output from the sensors, and / or optionally analyze data from the sensors. The patient monitoring device (00) can store data locally on a storage chip, encrypt the data, and send the data to a transmitter module (20) (e.g., a docking station, a patient mobile device). The transmitter module can send the data to a database server (29) and / or a network and / or other devices via a wireless network connection. Additionally or alternatively, the patient monitoring device (00) may include a transmitter module that sends data directly to a database server (29) and / or a network and / or other devices.

[0120] The database server (29) can receive the transmitted data, decrypt the data, analyze the data through a processor, and / or store the data on a memory chip. The database server (29) can also upload the processed data to a desktop and / or mobile device application (31) and / or a browser-based web access portal (41) or other software user interface through a secure access system. The database server can also generate an alert to a group of users (e.g., patients, health care providers, family members, partners, caregivers, etc.) directly or through a third-party service in the form of text messages, push notifications, automated calls, emails, etc.

[0121] The user interface system may include one or more browser-based web access portals (41) and / or device applications (31) that may be accessed by authorized users (e.g., health care providers, patients, caregivers, partners). The user interface system may transmit user authentication data and data requests to a database server (29) and / or download processed patient data from a database server (29) via a wired or wireless network connection, and display the data in a graphical user interface (GUI). Additionally or alternatively, the user interface system may include a GUI for patients and health care providers to input other data to be sent to the database server (29). The user interface system may also provide alerts to patients and health care providers, such as push notifications and pop-up message boxes, and provide alerts to patients and health care providers by using color highlighting of data deviations in the GUI.

[0122] Patient monitoring equipment can be fluidly connected to the catheter and inject or drain fluid in various configurations. Figure 1A Similar to the patient monitoring device (00) described above, variations of the patient monitoring device (00) may receive dialysate and include one or more sensors to measure one or more parameters of the dialysate, the sensor data may be transmitted, stored and / or analyzed as described above.

[0123] For example, Figure 1BAnother variation is shown in which the patient monitoring device (00) is coupled to the patient, such as at or near the exit site of the patient conduit (12). For example, the patient monitoring device (00) may include an adhesive patch, belt clip, or other device attached to or near the patient.

[0124] In one variation, the system is used for a patient undergoing peritoneal dialysis, and a set of fluid detection sensors can be connected to fresh dialysate infused into the patient and waste dialysate discharged from the patient. Fig.13 Shown is a patient monitoring device (00) connected to an indwelling catheter connector (14) and a separate connector (54) via a connector (53) after the junction (55) of the infusion dialysate container (56) and the drainage dialysate container (57), which is connected to the dialysate tube connector (13). In this variation, both the waste dialysate and the fresh dialysate flow through the same set of sensors. In this variation, the direction of flow can be determined by using a flow sensor and / or a pressure sensor so that the system can distinguish between infusion or drainage or identify when infusion or drainage occurs. In some variations, the flow sensor is constructed or selected to detect flow velocity and flow direction. In other examples, with or without sensor data from the flow sensor, a pressure sensor can be used to detect higher pressures during infusion and dialysate indwelling cycles and to detect a rapid drop in pressure during the drainage cycle. The system can be compatible and used with a variety of existing dialysis catheters and dialysate infusion systems, including continuous circulating peritoneal dialysis (CCPD) systems and continuous ambulatory peritoneal dialysis (CAPD) systems. Existing CCPD systems have some monitoring schemes, which this system can supplement. Current CAPD systems do not have monitoring schemes, and the system described in this article can provide this monitoring scheme.

[0125] In such Fig.14 In another variation shown, before the junction (62) of the infusion dialysate container (56) and the drainage dialysate container (57), the first patient monitoring device (00b) is connected to the tube (65) for the drainage dialysate container (57), and the second patient monitoring device (00a) is connected to the tube (63) for the infusion dialysate container (56). The first and second patient monitoring devices (00b, 00a) can be connected to each other by wire or wirelessly. At least one of the first and second patient monitoring devices (00b, 00a) can include one or more of the above-mentioned hardware processing, power supply, communication and data storage components.

[0126] exist Fig.15 In another variation shown, one set of sensors is connected to the waste dialysate solution port only. Fig.15The patient monitoring device (00) is shown connected only to the waste dialysate solution container (57) (e.g., bag) prior to the junction (64) of the infusion dialysate container (56) (e.g., bag) and the drain dialysate container (57). The drain dialysate bag is not often used, and in those cases, the drain line can be connected to a drain container, such as a toilet, bathtub, sink, etc. In this variation, the patient monitoring device only monitors the drain dialysate solution. Similarly, for patients undergoing CCPD, the patient monitoring device (00) can be connected to the waste dialysate solution drain tube, which is typically connected to a toilet, bathtub, drain bucket or similar disposal container.

[0127] One or more parts of the fluid conduit as described herein can be made of an optically transparent material having high optical transmittance over a wide wavelength range, which can maintain good optical clarity over time, such as one or more glasses, polyvinyl chloride (PVC), polysiloxanes, polycarbonates, fluorinated ethylene propylene copolymers (FEP), tetrafluoroethylene-hexafluoropropylene-vinylidene fluoride copolymers (THV), acrylic resins, or cyclic olefin copolymers (COC). Coating materials such as zwitterionic and polyethylene glycol hydrophilic coatings can also be used on polysiloxanes to prevent the fluid conduit from being biocontaminated. The fluid conduit can include one or more materials. For example, a glass tube segment can be integrated with a non-fluid contact light scattering and / or absorption sensor and connected to a free-standing PVC tube integrated with a fluid contact sensor (e.g., pH, temperature, pressure, impedance, and conductivity sensor) by overlapping joints or adhesives.

[0128] Patient Monitoring Devices

[0129] In some variations, the patient monitoring devices described herein may include two or more independent components that can be engaged with each other to provide full functionality. For example, a disposable component (e.g., a fluid conduit, a cartridge, a drainage line, a tube) may be configured to removably engage a durable component (e.g., a housing, a closure, a sensor module) of a patient monitoring device. In some variations, the durable component may include at least one sensor and processor to measure patient fluids and detect patient infection.

[0130] The disposable components may include fluid contacting components and the durable components may include a set of non-fluid contacting components. The disposable components may be replaced at predetermined intervals (e.g., daily, weekly) and / or predetermined criteria (e.g., patient infection events). The disposable components may be useful, for example, for short-term use, as bacterial growth in fluid conduits over time may result in an unacceptable number of false positive and / or false negative patient infection outputs. With proper calibration and maintenance (e.g., charging, cleaning), the durable components may provide long-term, multi-year functionality.

[0131] In some variations, a durable component may be used to measure fluid properties such as light scattering, light absorption, and / or fluid flow rate in a non-fluid contact manner without a separate sensor in the disposable component. As a result, manufacturing of the disposable component may be simplified and achieved at a reduced cost. In addition, the disposable component may be configured to attach to an existing drain line set to provide additional functionality to an existing peritoneal dialysis system. In some variations, the disposable component may replace an existing tubing set connector. Fig.67A An exemplary variation of a patient monitoring device (6700) is depicted that is coupled to a drainage line (6750) (e.g., a tube) and attached to a toilet (6760). The patient monitoring device (6700) includes a durable component (6710) (e.g., a housing, a closure) that is removably coupled to a mounting structure (6730), such as a hook configured to be attached to the edge of a toilet bowl (6760). For example, the durable component (6710) can be coupled to the mounting structure (6730) via magnets, interlocking and / or complementary structures, fasteners, and / or in any suitable manner. A disposable component (6720) (e.g., a fluid conduit) can be removably secured in an internal cavity of the durable component (6710). The durable component (6710) can include at least one lumen configured to allow fluid to flow therethrough. As described in more detail herein, the proximal end of the disposable component (6710) can be coupled to the distal end of the drainage line (6750) using a connector (6740). For example, the inlet of the fluid conduit (6720) can include a tube set connector (6740). The distal end of the disposable component (6720) can be configured to empty a fluid (e.g., a patient's bodily fluid) into a drainage container such as a toilet (6760). In some variations, a portion of the disposable component (6720) can be adapted to the shape (e.g., similar in profile) of the mounting structure (6730) to reduce the overall size and volume of the device (6700). The disposable component (6720) can include one or more portions, such as a rigid distal end configured to be connected to the tube set connector (6740) and a flexible proximal end configured to be removably engaged with the mounting structure (6730). For example, the flexible end of the disposable component (6720) can be wrapped around the mounting structure (6730). In some variations, disposable component (6720) may comprise a rigid curved end configured to removably attach the fluid conduit to the drain container such that the housing is separate from and does not contact the drain container.

[0132] Fig.67B Patient monitoring device (6700) is shown without being attached to drainage line (6750) and connector (6740).

[0133] Fig.68A and 68Bare perspective views of a patient monitoring device (6800) in closed and open configurations, respectively. The housing (6802) of the durable component may include a cover (6814) that may rotate about a hinge (6812). The housing (6802) may define an internal cavity (6816) that is configured to hold a disposable component (6830) (e.g., a fluid conduit). The fluid conduit (6830) may be configured to be removably engaged to the housing (6802). For example, the disposable component (6830) may be snap-fit ​​into the internal cavity (6816) of the housing (6802). The housing (6802) may be configured to be in an open configuration (6816) with the internal cavity (6816) exposed. Fig.68B ) and a closed configuration ( Fig.68A ). Fig.68A In the closed configuration shown, at least a portion of the fluid conduit (6830) may be shielded from external light and sealed from external fluids. The mounting structure (6840) may be removably attached to the housing (6802).

[0134] In some variations, the cover (6814) can be a set of flaps, a door, a slit, a cover, a shield, a latch, a fastener, or any other structure that allows the disposable component (6830) to be removably retained in the internal cavity (6816). For example, the disposable component (6830) can be pushed through the opening between a pair of flaps to engage the disposable component (6830) with the internal cavity (6816) of the housing (6802). When a release mechanism (e.g., an engagement structure (6820)) is actuated, the disposable component (6830) can be released and / or pushed out of the internal cavity (6816) through a pair of flaps. In some variations, the opening of the internal cavity (6816) can face the drainage container. This can allow a user to first attach the disposable component to the drainage container, and then allow the patient monitoring device to be pushed over the disposable component and against the drainage container. In order to disengage the patient monitoring device from the disposable component, the user can actuate the release mechanism and pull the durable component away from the disposable component and the drainage container.

[0135] The housing (6802) may include at least one non-contact fluid sensor (6822) configured to measure one or more parameters of a fluid flowing through the disposable component (6830). The sensor data measured using the sensor may be used to detect a patient infection. For example, the housing (6802) may include at least one optical sensor device (6822) arranged substantially perpendicular to the longitudinal axis of the internal cavity (6816) of the housing (6802). The optical sensor device (6822) may include at least one emitter and at least one detector. As described in more detail herein, one or more emitters may be configured to propagate light of one or more wavelength ranges through a patient's bodily fluid flowing through the fluid conduit (6830). At least one detector may be configured to receive light propagating through the fluid conduit (6830) and the patient's bodily fluid. In some variations, one or more emitters propagate light of a first wavelength range and a second wavelength range. The first wavelength range may be between about 700 nm and about 1 mm, and the second wavelength range may be between about 260 nm and about 550 nm. The emitter may include one or more of a light emitting diode, a laser, a collimator, a lens, a filter, and a scintillator. The detectors of the optical sensor device (6822) may be oriented about 180 degrees around the fluid conduit relative to the emitter (e.g., on the opposite side of the fluid conduit (6830)). Additionally or alternatively, one or more detectors may be oriented about 10-179 degrees relative to the emitter to capture scattered light. The optical sensor device (6822) may correspond, for example, to Fig.34 , 43 and any optical sensor described herein in 44.

[0136] In some variations, the patient monitoring device (6800) may also include at least one non-contact sensor including one or more of a pressure sensor, an image sensor, a flow sensor, an accelerometer, a gyroscope, a temperature sensor, and a magnetic field sensor. The image sensor may include one or more of a cell counter and a color sensor. For example, some sensors such as accelerometers and gyroscopes may be disposed in the housing (6802) separate from the internal cavity (6812) and the fluid conduit. Fig.69D One variation of a flow sensor is described in more detail.

[0137] The housing (6802) may include a controller including a processor and memory (not shown) and may be coupled to the optical sensor device (6822). The controller includes hardware and firmware, supported by program memory and random access memory, that controls one or more sensors, receives sensor data, processes sensor data, stores processed data in memory, communicates with a transmitter via a communication device or directly with a database server system (not shown), and manages power. The memory may store processed data until successful transmission of the data to the database server is confirmed. The charging port may be controlled by the controller to charge a local power source.

[0138] The controller can be configured to receive signal data corresponding to received light generated by at least one detector. As described in more detail herein, the controller can use the signal data to estimate total particle concentration data and white blood cell concentration data. The patient monitoring device can also include an electronic communication device (e.g., a wireless transmitter, a transceiver) and a power source (e.g., a battery) coupled to the controller.

[0139] In some variations, the patient monitoring device (6800) may include a user interface (e.g. Fig.72 ) (e.g., visual indicators), the user interface is configured to provide patient monitoring device status, patient status, fluid monitoring status, disposable component status, communication status, combinations thereof, etc. For example, the visual indicator may include an LED or LCD configured to display battery life, operating status, and disposable component status (e.g., attachment status, replacement status). The visual indicator may be configured to notify the patient to contact his or her physician or healthcare professional due to a detected patient infection event.

[0140] Fig.68C6 is an exploded assembly diagram of a patient monitoring device (6800). The fluid conduit (6830) can be configured to be fixed in the internal cavity (6816) by friction fit and / or mechanical mutual fit. For example, the housing (6802) includes a fluid conduit engagement structure (6828) (e.g., a bracket or other recess) that can be matched with a corresponding housing engagement structure (6834) on the fluid conduit (6830). The housing (6802) can also include an engagement sensor (e.g., a switch, an optical sensor) that is configured to generate a sensor signal when the fluid conduit engagement structure (6828) and its corresponding housing engagement structure (6834) are matched. The housing (6802) can include a seal (6818) that is configured to prevent fluid or gas (i.e., hot and humid air from a shower) from entering the internal cavity (6816) of the housing (6802) in a closed configuration. The seal (6818) can, for example, include a gasket, a skirt, or other suitable seal. The cover (6814) can include a housing engagement structure (6821) that can cooperate with a corresponding cover engagement structure (6820) (e.g., a spring-loaded latch release) of the housing (6802). For example, when a button (6820) on one side of the housing (6802) is pressed, the cover (6814) can be released and rotated about the hinge (6812). The power source (6824) (e.g., a battery) can be removable from the housing (6804) and can be encapsulated by the cover (6826). As described in more detail herein, the mounting structure (6840) can be removably coupled to the housing (6802). One or more components of the patient monitoring device (e.g., a battery, a cover, a memory, a sensor, a fluid conduit) can be removable to facilitate one or more of replacement, cleaning, data transmission, and charging. In some variations, redundant components can be provided, such as redundant batteries and / or memories.

[0141] The fluid conduit (6830) may include an inlet (6832) configured to couple to at least one of an indwelling catheter and a drainage line, and an outlet (6834) configured to lead to a drainage container. Fig.70A and 70B The fluid conduit (6830) is described in more detail.

[0142] Figures 69A-69D6 is a perspective view of a patient monitoring device (6900) similar to patient monitoring device (6800), except that disposable components and mounting structures have been removed for clarity. The housing (6902) of the durable components may include a cover (6914) that may be rotated about a hinge (6912). The housing (6902) may define an interior cavity (6916) that is configured to hold disposable components (e.g., a fluid conduit). The housing (6902) is configured to be opened in an open configuration (6916) with the interior cavity (6916) exposed. Fig.69B ) and a closed configuration ( Fig.69A ). The housing (6902) may include at least one non-contact fluid sensor (6922) configured to measure one or more parameters of a fluid flowing through the disposable component. For example, the housing (6902) may include at least one optical sensor (6922) arranged perpendicular to a longitudinal axis of an interior cavity (6916) of the housing (6902). Fig.69C A pair of optical sensors (6922) (e.g., optical sensor devices) are shown that are configured to transmit and receive light that passes through the internal cavity (6916). For example, each optical sensor (6922) may include an emitter and two detectors that are arranged about 90 degrees and about 180 degrees relative to the emitter around the catheter.

[0143] Fig.69C An open configuration of a patient monitoring device (6900) including a power source (6924) and a cover (6926) is shown. The cover (6926) may include a fluid seal (e.g., a gasket) to prevent fluid from entering. The housing (6902) includes a fluid conduit engagement structure (6928) that can cooperate with the fluid conduit. The housing (6902) may also include an engagement sensor (e.g., a switch, an optical sensor) configured to generate a sensor signal when the fluid conduit engagement structure (6928) cooperates with the fluid conduit. The housing (6902) may include a seal (6918) configured to prevent fluid from entering the internal cavity (6916) of the housing (6902) in the closed configuration. The cover (6914) may include a housing engagement structure (6921) (e.g., a latch) that can cooperate with a corresponding cover engagement structure (6920) (e.g., a spring-loaded latch release) of the housing (6902).

[0144] Fig.69D is a detailed perspective view of the interior cavity (6916) of the patient monitoring device (6900). In some variations, the optical sensor device may include one or more emitters (6923) and one or more detectors (6927). Fig.69D In the embodiment, the emitters (6923) and detectors (6927) are oriented at 180 degree intervals around the circumference of the cavity (6916), however, the emitters (6923) and detectors (6927) may also be oriented at forward scattering angles (>90 degrees, <180 degrees), side scattering angles (90 degrees), or back scattering angles (<90 degrees, ≥0 degrees). The internal cavity (6916) of the housing (6902) may also define other cavities (6917) that are configured to hold, for example, about Fig.70A and 70B The second fluid conduit.

[0145] At least one sensor (6919) (e.g., an optical sensor including a light emitter and a light detector) can be configured to measure a fluid level in the cavity (6917). The sensor (6919) can be configured to generate signal data corresponding to a fluid flow rate of a patient's bodily fluid flowing through a disposable component (e.g., a fluid conduit). The cavity (6917) can extend parallel to a longitudinal axis of the interior cavity (6916). At least a portion of the cavity (6917) can be shielded from external light and sealed from external fluids.

[0146] Fig.70A and 70B A perspective view of a disposable component such as a fluid conduit 7000 defining a lumen (7002) (e.g., a fluid flow channel, a fluid flow path) is shown. The fluid conduit (7000) may include an inlet (7020) and an outlet (7030). For example, the fluid conduit (7000) may include an inlet (7020) and an outlet (7030), the inlet (7020) being configured to be coupled to at least one of an indwelling catheter and a drainage line, and the outlet (7030) being configured to lead to a drainage container. The fluid conduit (7000) may have a curved shape, such as an L-shape, a J-shape, an S-shape, a U-shape, a C-shape, a combination thereof, and the like, to, for example, accommodate and couple to the edge of a drainage container such as a toilet or a sink. The shape and diameter of the fluid conduit (7000) may be configured to reduce clogging and obstruction of solid particles such as fibrin in the fluid.

[0147] In some variations, the inlet (7020) may include a connector, which may have threads and / or a taper, for example. The inlet may include a barb fitting configured to couple to a standard tube set drainage line. The fluid conduit (7000) may include one or more engagement structures (7040), such as tabs, configured to align the lumen (7002) of the fluid conduit (7000) with the internal cavity of the durable component. In some variations, the fluid conduit (7000) may include at least one fluid contact sensor, including one or more of a flow sensor, a conductivity sensor, a temperature sensor, a pH sensor, a lactate sensor, a test strip, a chemiluminescent sensor, an electrochemical sensor, and a glucose sensor.

[0148] In some variations, the fluid conduit (7000) includes at least one optical sensing region configured to allow an optical sensor to optically measure a fluid property of a patient's bodily fluid flow. For example, the fluid conduit (7000) includes at least one transparent portion (7010) disposed between an inlet (7020) and an outlet (7030) along any portion of the fluid conduit (7000) and adapted to allow an optical sensor device to measure light transmitted through the transparent portion (7010). For example, the transparent portion may be positioned along the length of the fluid conduit (7000) such that when the fluid conduit (7000) is held within an interior cavity of the durable component, the transparent portion is shielded from external light. In some variations, a transparent portion (7010, 7050) of the fluid conduit (7000) may be provided for each fluid property to be measured (e.g., light scattering, light absorption, fluid flow rate).

[0149] The transparent portion is transparent to at least one of ultraviolet light, visible light, and infrared radiation. One or more portions of the fluid conduit (7000) may be made of, for example, one or more of the following materials: acrylic resin, polycarbonate, cyclic olefin copolymer (COC), fluorinated ethylene propylene copolymer (FEP), tetrafluoroethylene-hexafluoropropylene-vinylidene fluoride copolymer (THV), polycarbonate, polystyrene, acrylonitrile-butadiene-styrene (ABS), polysiloxane coated with polyethylene glycol, polyurethane coated with zwitterions, polyvinyl chloride coated with polyethylene oxide, and polyamphiphilic silicone. For example, the entire fluid conduit (7000) may be transparent, or the portion of the fluid conduit (7000) that is held in the interior cavity of the durable component may be transparent. The transparent portion (7010) may be made of a different material (and having a different transparency) than other portions of the fluid conduit (7000).

[0150] In some variations, the exterior of the fluid conduit (7000) may include one or more operating interfaces (e.g., protrusions, handles) configured to be manipulated by the patient. This can reduce patient contact with sensitive portions of the fluid conduit (7000) (e.g., inlets and transparent portions) that may otherwise alter the sensor's measurements. For example, a set of spaced-apart protrusions may be provided around the circumference of the transparent portion that are not within the line of sight of any emitter or detector. In addition, markings may be provided on the fluid conduit (7000) to indicate operating interfaces and / or sensitive portions that should be kept sterile (e.g., free of fingerprints and other contact).

[0151] In order to save power usage of the entire system, it is desirable that each sensor operates only when necessary. In some variations, the patient monitoring device may perform patient complication detection only when fluid flows through the fluid conduit, thereby reducing power consumption and unnecessary data generation. In some applications, such as continuous cycle peritoneal dialysis (CCPD), a cycle will include infusion, indwelling and drainage steps, wherein the patient monitoring device may only need to monitor the drainage step. The fluid conduit will initially be empty, from which the optical sensor device can measure and determine when the initial drainage time begins. However, after the first drainage cycle is completed, the fluid conduit may have residual fluid, which may not allow accurate measurement of the initial drainage time of subsequent cycles. Therefore, in subsequent replacements, the measurement of the fluid flow rate can be used to estimate the initial drainage time of the cycle. A fluid flow sensor can be used to determine when fluid is flowing through the fluid conduit. When the fluid flow sensor indicates that fluid is flowing through the fluid conduit, one or more other patient monitoring sensors can start to run continuously, otherwise, during the period when the fluid flow sensor indicates that there is no fluid flow, it runs at a lower duty cycle. Typically, patient monitoring devices can operate in a low-power mode during periods of no fluid flow (i.e., during the infusion and dwell steps of a cycle). When fluid flow is detected, the sensor can be turned on and signal data can be generated.

[0152] The measurement of fluid flow can be performed by any suitable mechanism. For example, the patient monitoring system can use one or more optical sensors of the patient monitoring device to generate a fluid flow signal. As another example, the patient monitoring device may include an accelerometer configured to detect vibrations corresponding to the actuation of the fluid pump and the fluid flow. As another example, the patient monitoring device may include an audio device (e.g., a microphone) configured to detect sound patterns corresponding to one or more of the actuation of the fluid pump and the fluid flow. Additionally or alternatively, when the drainage cycle begins, a fluid flow signal (e.g., via wireless communication) can be received from a cycle meter and / or a patient to indicate the start or end of fluid flow (e.g., pumping). The patient monitoring device described herein may include a non-fluid contact flow sensor configured to determine the fluid flow state in a fluid conduit. Figures 70 and 74-76 are exemplary variations of a fluid conduit, which include a portion configured to be measured by a flow sensor, as described below.

[0153] In some variations, such as Fig.70A and 70B As shown, the first fluid conduit (7000) includes a second fluid conduit (7050) (which may be a closed end) branching or bifurcating from the first (e.g., main) fluid conduit (7000). Typically, as described below, the second fluid conduit (7050) can capture a certain volume of fluid that can be related to the flow rate. The second fluid conduit (7050) can be configured to be parallel to the first fluid conduit (7000). Although the position of the second fluid conduit relative to the first fluid conduit (7000) is described as being substantially vertical, it should be understood that in other variations, the second fluid conduit and the first fluid conduit can be oriented in any suitable direction. One end of the second fluid conduit (7050) can be sealed to prevent air / fluid leakage. The diameter of the second fluid conduit (7050) can be smaller than the diameter of the lumen (7002). The second fluid conduit (7050) can include at least one transparent portion similar to the transparent portion (7010) of the first fluid conduit (7000). As fluid flows through lumen (7002), a volume of fluid fills the lower portion of closure (7050) and a volume of air is compressed and trapped in the upper portion of closure (7050).

[0154] The volume of fluid in the second fluid conduit (7050) (e.g., the height of the fluid-filled closure (7050)) can correspond to the flow rate of the patient's bodily fluid in the fluid conduit (7000). For example, when there is no fluid flow, the pressure in the fluid conduit (7000) is minimal, so that the liquid level in the closure (7050) will be low. When fluid flows through the fluid conduit (7000), the positive pressure in the fluid conduit (7000) will compress the air in the closure (7050) and increase the liquid level in the closure (7050). Therefore, the greater the flow rate, the higher the liquid level in the closure (7050) (or generally for other second fluid conduit orientations, the greater the length of fluid entering the second fluid conduit). A sensor such as an optical sensor can be configured to measure the fluid height in the closure (7050), thereby allowing the controller to estimate the fluid flow rate. In some variations, the fluid flow sensor may include an optical sensor device that includes at least one emitter and at least one detector.

[0155] In some variations, detection of fluid flow rate, including the start and / or end (termination) of fluid flow, may be used to determine when to begin and end patient infection testing. Fig.74 -76 depicts other variations of fluid flow detection mechanisms. Fig.74 is a perspective view of a disposable component such as a fluid conduit (7400) defining a lumen (7402) (e.g., a channel, a path). The fluid conduit (7400) may include an inlet (7430) and an outlet (7440). For example, the fluid conduit (7400) may include an inlet (7430) configured to couple to at least one of an indwelling catheter and a drainage line and an outlet (7440) configured to lead to a drainage container. The fluid conduit (7400) may include one or more engagement structures (7450), such as tabs, configured to align the lumen (7402) of the fluid conduit (7400) with an internal cavity of the durable component. In Fig.70A and 70B In the embodiment of the present invention, the fluid conduit 7002 includes a first transparent portion (7010) configured for patient infection measurement (e.g., light scattering and / or light absorption) and a second transparent portion (7050) configured for measuring fluid flow. The transparent portions (7010, 7050) can be substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. The transparent portions (7010, 7050) can be made of a different material (and have a different transparency) than other portions of the fluid conduit (7002).

[0156] In some variations, such as Fig.74As shown, the second transparent portion (7412) includes a spherical flow sensing portion (7420), which includes a ball (7422) that is arranged in the fluid lumen (7402) near one or more stops. Typically, in response to an increased fluid flow rate, the height of the ball (7422) in the flow sensing portion (7420) will shift (e.g., rise) relative to the stop. For example, when no fluid is flowing through the fluid conduit (7400), the ball (7422) has neutral buoyancy or slight negative buoyancy and will rest at the bottom of the flow sensing portion (7420). The optical sensor can be configured to detect the position of the ball (7422) and generate a fluid flow signal based on the position of the ball. In some variations, the fluid flow signal can be a binary signal, such as fluid flow ON and fluid flow OFF.

[0157] Fig.75A and 75B A first variation of an optical sensor and flow sensing portion (e.g., a spherical flow sensor) is shown. A fluid conduit (7510) includes a flow sensing portion that includes a ball (7530) and a first inner radially extending device (7520) and / or a second inner radially extending device (7522). The first and second devices (7520, 7522) can be longitudinally or axially spaced apart in the fluid conduit (7510). The ball can be arranged between the first and second devices such that the first and second devices are configured to limit the range of motion of the ball (7530) in the fluid conduit (7510) (e.g., the travel of the ball is limited by one device in the proximal direction and by another device in the distal direction). For example, the optical sensor device includes an emitter (7540) and a detector (7542), and the optical sensor device can be configured to transmit and receive light that passes through a transparent portion of the fluid conduit (7510). For example, when fluid is not flowing through the fluid conduit (7510), the ball (7530) rests at Fig.75A The light emitted by the emitter (7540) is substantially transmitted through the transparent portion of the fluid conduit (7510) and is received by the detector (7542). When the fluid flows through the fluid conduit (7510), the ball (7530) is pushed into the Fig.75B The second device (7522) in the transmitter (7540) is substantially blocked by the ball (7530). The valve can be a one-way valve that prevents fluid from flowing to the inlet of the fluid conduit. In some variations, the ball and the flow sensing portion can be arranged in parallel fluid conduit paths.

[0158] Fig.76A and 76B A second variation of the optical sensor and flow sensing portion is shown. The configuration and operation of the fluid conduit (7610) is similar to Fig.75A and75B , except that the first device in the lumen of the fluid conduit (7610) may include a reduced diameter or neck-shaped portion (7630) configured to receive or retain the ball (7620) and provide a fluid seal when there is no fluid flow. This variation acts as a one-way valve that blocks the flow of fluid along the Fig.76A and 76B The fluid conduit (7610) further includes a second device (7622) (e.g., a set of one or more sharp teeth) configured to limit the range of motion of the ball in the fluid conduit (7610), but still allow the fluid to flow along the fluid conduit (7610). Fig.76A and 76B The optical sensor device including the emitter (7640) and the detector (7642) can be configured to transmit and receive light passing through the transparent portion of the fluid conduit (7610). The optical sensor can be positioned along any portion of the valve such that occlusion of light by the ball (7620) corresponds to fluid flow, and significant light transmission corresponds to no fluid flow.

[0159] The fluid conduits described herein can be constructed in one or more parts. For example, one or more transparent parts of the fluid conduit (e.g., the optical sensing area) can be formed separately from other parts and connected together to form a one-piece component by any suitable method, including but not limited to molding, welding, bonding, adhesives, mechanical interfitting, etc.

[0160] Additionally or alternatively, one or more portions of the fluid conduit may be comprised of a material that is susceptible to bacterial scaling / contamination. That is, one or more portions of the fluid conduit may be comprised of a material that allows for improved growth of bacteria on the inner wall surface of the fluid conduit compared to a surface that does not include the material. In some variations, the fluid conduit may include a plurality of parallel channels. In some variations, the fluid conduit may include one or more valves, such as a one-way valve. In some variations, the fluid conduit may be configured to be replaced at predetermined intervals (e.g., every day, every two days, every week).

[0161] Figures 71A-71B A perspective view of a mounting structure (7130) (eg, a mounting member) of a patient monitoring device (7100) is shown. Fig.71A is a perspective view of a patient monitoring device (7100) comprising a durable component (7110) such as described herein and a disposable component (7120). Fig.71BA mounting member (7130) is shown that includes a housing engagement structure (7140). In some variations, the housing engagement structure (7140) may include a magnet in a recess. The mounting member (7130) may be configured to removably attach the housing (7110) to a drainage container such as a toilet. The mounting member (7130) may be bent into the shape of a hook to allow the patient monitoring device (7100) to adapt to or removably hang from the drainage container. The mounting member may alternatively be constructed of a semi-flexible material (e.g., a polymer overmolded on an armature wire) to allow the user to form the bend. Fig.71C A housing (7110) is shown comprising a mount engagement structure (7112) which may comprise a magnet which, in some variations, may protrude from a surface of the housing (7110). Fig.71D The mounting structure (7130) is shown coupled to the housing (7110). In some variations, the mounting structure (7130) may include an adhesive (7150) configured to adhere to the drainage container. Figures 71A-71D The mounting member (7130) is depicted as being disposed on a side of the housing (7110) opposite the internal cavity of the patient monitoring device, but the mounting member (7130) may be disposed on any surface of the housing (7110). For example, the mounting member (7130) may be disposed on the same side of the housing (7110) as the internal cavity, such that when the mounting member (7130) couples the housing (7110) to the drainage container, the internal cavity of the housing (7110) may face the drainage container.

[0162] Methods for detecting infection in patients

[0163] In some variations, a method of detecting an infection in a patient using a patient monitoring device such as those shown in FIGS. 67-71 and 74-76 may include the step of attaching a mounting structure (e.g., a clip) to a drainage container (e.g., a toilet). Durable components of the patient monitoring device may be attached to the mounting structure. If necessary, a power source such as a battery may be inserted into the patient monitoring device ( Fig.69C ). A disposable component (e.g., a fluid conduit, a drain line extension tube) can be connected to a tube set drain line, such as those manufactured by Baxter and Fresenius. The disposable component can be coupled to a durable component such that a transparent sensing portion of the fluid conduit is optically coupled to a sensor of the durable component. The durable component can then be activated and used to monitor fluid and / or patient parameters, and to generate data and / or alarms.

[0164] In another variation, the disposable component may first be coupled to the distal end of the tube set drain line. The disposable component may then be attached to the drain container. The durable component may be removably coupled to the disposable component. For example, the patient monitoring device may be clipped onto a transparent portion of the disposable component.

[0165] In some variations, a calibration process can be performed when a disposable component is joined to a durable component. For example, one or more optical sensors can confirm detection of a fluid conduit when a joining signal is received. Alternatively, a switch can be actuated when a fluid conduit is inserted. After the fluid conduit is assembled, optical sensor data can be used to authenticate the fluid conduit and confirm fluid conduit parameters, such as transparency and / or sterility. For example, if an incompatible tube is placed in the internal cavity of a patient monitoring device, the patient monitoring device can be disabled and / or an alarm is sounded. Even if the fluid conduit is authenticated, if the fluid conduit is not within a predetermined tolerance (e.g., wall thickness, color, transparency), an optical sensor can also be used to generate an error. This can prevent patients from trying to use a fluid conduit that is unacceptable due to reuse, bacterial scaling, loss of sterility (e.g., fingerprints), expiration, manufacturing errors, combinations thereof, etc. In some variations, optical sensor measurements of patient fluids can be modified based on the calibration performed.

[0166] In some variations, a patient fluid may be received by a fluid conduit coupled to or disposed near a sensor. A fluid flow signal may be received and used to initiate one or more fluid property measurements. For example, a patient monitoring device may use an optical sensor device and / or an accelerometer to generate a fluid flow signal. Additionally or alternatively, a periodometer may output a fluid flow signal. In response to the fluid flow signal, a sensor may be used to measure fluid properties such as light scattering and / or absorption of the patient fluid within one or more wavelength ranges (bands). The particle concentration and / or leukocyte concentration of the patient fluid may be estimated based at least in part on the measurement results of light scattering and / or absorption within one or more wavelength ranges. The infection status of the patient may be detected based at least in part on the estimated leukocyte concentration. The patient fluid is discharged from the patient.

[0167] In some variations, the measurement of light scattering and / or absorption within a first wavelength range can be related to the total particle concentration of the patient's body fluid, and the measurement of light scattering and / or absorption within a second wavelength range can be related to a specific white blood cell concentration of the patient's body fluid, wherein the first wavelength range is different from the second wavelength range. For example, the first wavelength range can be between about 700nm and about 1mm, and the second wavelength range can be between about 260nm and about 550nm. In some variations, the second wavelength range can correspond to the non-leukocyte particle concentration of the patient's body fluid. For example, the second wavelength range can include specific particle type wavelengths (e.g., red blood cells, fibrin, triglycerides), and does not include wavelengths between about 260nm and about 550nm. The white blood cell concentration can be calculated by subtracting the non-leukocyte concentration from the total particle concentration.

[0168] In some variations, a first optical sensor device may initially measure light scattering and / or absorption by the fluid within a first wavelength range. If the measurement exceeds a predetermined threshold (e.g., corresponding to a potential infection), a second optical sensor device may measure light scattering and / or absorption by the fluid within a second wavelength range. A ratio of the signals from the first optical sensor device and the second optical sensor device may be calculated.

[0169] In some variations, a patient monitoring device may be configured to use a sensor to measure the uniformity of a patient's bodily fluid. Based at least in part on the measured uniformity, a set of light scatter and / or absorption measurements may be excluded from a leukocyte concentration estimate. For example, non-uniform fluid flow due to large particles and / or mixed particles (e.g., fibrin) may produce sensor measurements that form an inaccurate concentration estimate. Excluding sensor measurements for periods of non-uniform flow may improve the accuracy of a fluid flow analysis (e.g., a leukocyte concentration estimate).

[0170] In some variations, a patient monitoring device may be coupled between a dialysate container and a dialysate line to receive dialysate through a fluid conduit in which the dialysate is to be injected into the patient. One or more sensors may be used to measure light scatter and / or absorption of the dialysate. An estimated leukocyte concentration may be based at least in part on measurements of light scatter and / or absorption of the dialysate. A difference in light scatter and / or absorption between a patient's bodily fluid and the dialysate may be estimated by the patient monitoring device. The infection status of the patient may be updated based at least in part on a difference or ratio of light scatter and / or absorption.

[0171] As described herein, a flow sensor coupled to a fluid conduit can be used to measure the flow rate, total flow, and / or flow direction of a patient's body fluid. Measurements of light scattering and / or absorption can be normalized based at least in part on flow rate measurements or total flow. One or more patient body fluid measurements can be standardized based at least in part on flow rate or total flow measurements. One or more of blockage and flow direction can be detected based at least in part on flow rate measurements. One or more of infusion volume, drainage volume, infusion time, drainage time, and dwell time can be estimated based at least in part on flow rate measurements. For example, when a patient monitoring device begins to measure a new fluid flow for a circulation machine, dwell time and drainage time can be estimated, and the circulation machine measures multiple drainage cycles through intermediate dwell cycles. In some variations, an ultrasonic flow sensor coupled to a fluid conduit, an accelerometer configured to detect vibrations corresponding to fluid pump activation, and data communication with a circulation machine can be used to determine fluid flow parameters.

[0172] One or more of dialysis efficiency and dialysis adequacy may be estimated based at least in part on the estimated infusion volume, drainage volume, and dwell time.One or more of an infusion state and a drainage state of a patient's bodily fluid may be detected without user input.

[0173] In some variations, at least one alert may be output that includes one or more of the patient's infection status, the patient's compliance with prescribed therapy, treatment effectiveness, sensor calibration, fluid conduit maintenance, and sensor data. The alert may include notifying at least one predetermined contact, including one or more of the patient, a healthcare professional, a partner of the patient, a family member, and a healthcare provider.

[0174] In response to an alert corresponding to the patient being in a high risk condition, a communication channel can be established between the patient and the health care professional. At least one alert threshold corresponding to turbidity, fluid flow, and conductivity can be set based on user input. An alert corresponding to treatment effectiveness can be output based at least in part on flow measurements and conductivity measurements. An alert corresponding to fluid conduit obstruction can be output based at least in part on pressure measurements and acceleration measurements. A patient infection alert can be output based on one or more patient fluid measurements.

[0175] Other patient monitoring devices

[0176] In some variations, a disposable component of a patient monitoring device may include a fluid conduit and one or more sensors, which may be, for example, a limited use sensor having a limited service life and which may be replaced simultaneously with the fluid conduit. For example, a disposable component may include at least one fluid contact sensor that may be configured to measure at least one fluid property of a patient's body fluid in a fluid conduit, such as fluid ion conductivity. Thus, the number of sensors in a durable component may be reduced, thereby allowing the size of the durable component to be reduced. Replacement of fluid-contacting components also eliminates the need for cleaning and maintenance of fluid-contacting components that are susceptible to biofouling and corrosion. In some variations, a set of disposable components compatible with a single durable component may be configured with different sensor devices for different applications and measurement requirements. Fig.64A An exemplary variation of a patient monitoring device (6400) is shown that is configured to be coupled to a drainage line (e.g., a connector tube) and attached to a toilet (6450). The patient monitoring device (6400) includes a durable component (6410) (e.g., a housing, a closure) that is removably coupled to a mounting structure (6430), such as a hook configured to be attached to the edge of a toilet bowl (6450). A disposable component (6420) (e.g., a fluid conduit) can be removably secured in an internal cavity of the durable component (6410). The durable component (6410) can include an engagement structure (6412) (e.g., a spring-loaded latch release) that is configured to release the disposable component (6420) from the cavity of the durable component (6410). The durable component (6410) can include at least one lumen that is configured to removably engage and retain the fluid conduit. As described in more detail herein, a connector (6440) can be used to couple the proximal end of the disposable component (6420) to the distal end of the drainage line. For example, the inlet of the fluid conduit (6420) can include a tube set connector (6440). The distal end of the disposable component (6420) can be configured to empty fluid (e.g., patient fluids) into a drainage container such as a toilet (6450). In some variations, a portion of the disposable component (6420) can be adapted to the shape of the mounting structure (6430) to reduce the overall size and volume of the device (6400).

[0177] Fig.65 A durable component (6500) of a patient monitoring device is shown. The housing (6510) of the durable component (6500) may include a lumen (6520) and a cavity (6530) configured to retain and / or removably engage one or more disposable components (6600, 6660) of the patient monitoring device (see Figures 66A-66D ). For example, Fig.66E and66F As shown, the first disposable component (6600) can be snap-fitted into the cavity (6530), and the second disposable component (6660) can be screwed into the first disposable component (6600) and retained in the tubular cavity (6520) of the durable component (6500). The housing (6510) can also include a connector (6532) configured to provide an electrical connection (e.g., electronic contacts) with the first disposable component (6600) to charge and / or communicate between the durable component (6500) and the first disposable component (6660). For example, the connector (6532) can include a USB port or a dedicated connector configured to provide power and / or data transfer capabilities. The connector (6532) coupled to the first disposable component can also constitute a fluid seal (e.g., an IP67 certified fluid seal). When coupled to the durable portion (6500), at least a portion of the disposable portion (6600, 6660) may be shielded from external light and sealed from external fluids.The mounting structure may be removably attached to the durable portion (6500).

[0178] The durable component (6500) may include at least one non-contact fluid sensor (6522) configured to measure one or more parameters of a fluid flowing through the disposable component (6600, 6660). Sensor data measured using the sensor (6522) may be used to detect an infection in a patient. For example, the durable component (6500) may include at least one optical sensor (6522) arranged substantially perpendicular to a longitudinal axis of a lumen (6520) of the durable component (6500). As described in detail herein, the optical sensor (6522) may include an emitter and at least one detector. The optical sensor (6522) may correspond to, for example, Fig.34 , 43 , 44, 68 and 69 of any of the optical sensors described herein.

[0179] In some variations, the patient monitoring device (6500) may also include at least one non-contact sensor including one or more of a pressure sensor, an image sensor, a flow sensor, an accelerometer, a gyroscope, a temperature sensor, and a magnetic field sensor. The image sensor may include one or more of a cell counter and a color sensor. For example, some sensors, such as accelerometers and gyroscopes, may be provided in the housing (6510) separately from the lumen (6520) and the cavity (6530).

[0180] The durable component (6500) may include a controller including a processor and a memory (not shown) and may be coupled to the optical sensor (6522). The controller includes hardware and firmware, supported by program memory and random access memory, that controls one or more sensors, receives sensor data, processes sensor data, stores processed data in memory, communicates with a transmitter via a communication device or directly with a database server system (not shown), and manages power. The memory may store the processed data until successful transmission of the data to the database server is confirmed. The charging port may be controlled by the controller to charge a local power source. The controller may be configured to receive signal data corresponding to received light generated by at least one detector. As described in more detail herein, the controller may use the signal data to estimate total particle concentration data and white blood cell concentration data. The patient monitoring device may also include an electronic communication device (e.g., a wireless transmitter, a transceiver) and a power source (e.g., a battery) coupled to the controller. In some variations, the durable component (6500) may include a user interface (e.g., as described in more detail herein) as described in more detail herein. Fig.72 shown and described).

[0181] The first disposable component (6600) is configured to be fixed in the cavity (6530) by friction fit or mechanical mutual fit. For example, the housing (6510) includes a disposable component engagement structure (6540) (e.g., a spring-loaded pin) that can cooperate with the first disposable component (6600). The housing (6510) may also include an engagement sensor (e.g., a switch, an optical sensor) that is configured to generate a sensor signal when the first disposable component (6600) is arranged in the cavity (6530). The engagement structure (6540) can be pushed inward to release the first disposable component (6600) from the cavity (6530). One or more components of the patient monitoring device (e.g., batteries, memory, sensors) can be removable to facilitate one or more of replacement, cleaning, data transmission and charging. In some variations, redundant components, such as redundant batteries and / or memories, can be provided.

[0182] Fig.66A and 66B6 is a perspective view of a first disposable component (6600) comprising a housing (6602) defining a first fluid conduit (6610) coupled to an inlet (6620) and an outlet (6630). The outlet (6630) of the first disposable component (6600) can be coupled to the proximal end of a drainage line leading to a drainage container. For example, the outlet (6630) can include a barb fitting. The inlet (6620) of the first disposable component (6600) can be configured to be coupled to the outlet of the second disposable component (6660). For example, the inlet (6620) can include a concave Luer lock fitting. The first disposable component (6600) can include one or more fluid contact sensors (6640), such as a flow sensor, an ionic conductivity sensor, and a fluid temperature sensor. In some variations, the first disposable component (6600) can be configured to be replaced at predetermined intervals (e.g., weekly, biweekly, monthly). The housing (6602) may also include a connector (6650) configured to provide an electrical connection (e.g., an electronic contact point) with a corresponding connector of the durable component (6500) for power and / or communication. The connector (6650) may be coupled to each fluid contact sensor (6640).

[0183] Fig.66C 6 is a perspective view of a second disposable component (6660) comprising a housing (6661) defining a second fluid conduit (6662) coupled to an inlet (6668) and an outlet (6666). The inlet (6668) of the second disposable component (6660) can be coupled to the end of a drainage line. For example, the inlet (6668) can include a barb fitting (e.g., a double barb fitting) that can be configured to be difficult to disassemble when coupled. The outlet (6666) of the second disposable component (6660) can be configured to be coupled to the inlet of the first disposable component (6600). For example, the outlet (6666) can include a male Luer fitting. In some variations, the second disposable component can be configured to be replaced at predetermined intervals (e.g., daily, weekly, biweekly). The second disposable component can be replaced at a higher frequency than the first disposable component. For example, the second disposable component (6660) can be replaced daily with a circulating machine tube set. The second disposable component (6660) may include an engagement feature (6664) configured to assist a user in rotating the second disposable component (6660) into the first disposable component (6600). When the second disposable component (6660) is fully coupled to the first disposable component (6600), any thread lines or parting lines of the second disposable component (6660) may not be within the field of view of the optical sensor (6522) of the durable component (6500).

[0184] The housing (6661) includes at least one transparent portion (6663) that is substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. For example, one or more portions of the housing (6661) include one or more of the following: acrylic resin, polycarbonate, cyclic olefin copolymer (COC), polystyrene, acrylonitrile-butadiene-styrene (ABS), polysiloxane coated with polyethylene glycol, polyurethane coated with zwitterions, polyvinyl chloride coated with polyethylene oxide, and amphiphilic polysiloxane. The transparent portion (6663) may be made of a material different from (and having a different transparency than) the rest of the housing (6661). The second disposable component (6660) may be formed by injection molding and may be formed as a one-piece or multi-piece component. The first and second disposable components may be sterile when provided to the patient.

[0185] Fig.66D is a perspective view of a first disposable component (6600) coupled to a second disposable component (6660). In some variations, an inlet (6668) of the second disposable component (6660) can be coupled to the end of a drainage line. An outlet (6666) of the second disposable component (6660) can be configured to couple to an inlet (6630) of the first disposable component (6600). An outlet (6620) of the first disposable component (6600) can be coupled to a tube configured to lead to a drainage container, such as a toilet.

[0186] Figure 2An exemplary hardware configuration for an electrical layout of patient monitoring device hardware is shown. Various sensing technologies in a housing or enclosure (26), connections to other electrical components, and a fluid conduit (15) are shown. A set of sensors connected to the fluid conduit (15) may include a flow sensor (1), an optical sensor (2), a temperature sensor (3), a pressure sensor (4), a conductivity sensor (5), a pH sensor (6), a glucose sensor (7), a lactate sensor (8), a cell counter (9), a urea sensor (10), and a creatinine sensor (11). In some variations, the patient monitoring device (00) may include one or more sensors configured to detect patient infection. The patient infection sensor may include a spectral sensor, such as a light scattering / absorption sensor. For example, the fluid light scattering / absorption sensor (2) may be optically connected to the fluid conduit (15) so that the light emitter and detector have sufficient optical clarity to measure the fluid in the fluid conduit (15). An accelerometer and gyroscope position sensor (23) may be fixed in the enclosure (26). The skin color sensor (24) and / or the skin surface temperature sensor (25) may be positioned such that the sensor is exposed to the skin surface or is located on the skin surface in close proximity to the indwelling catheter exit site. The first connector (13) is configured to connect to one or more infusion and drainage dialysate containers ( Figure 2 The first connector (13) and the second connector (14) are configured to be connected to an indwelling catheter (not shown), and the first connector (13) and the second connector (14) allow the system to detect all inflowing and outflowing fluids. The processor (16) includes hardware and firmware, which, with the support of a program memory and a random access memory (17), controls the sensor network, receives sensor data, processes sensor data, stores processed data in a memory module (19), communicates with a transmitter (e.g., via Bluetooth, Wi-Fi) or directly (e.g., via an LTE cellular network) with a database server system (not shown) through a wireless communication module (18), and manages a local power supply (21). The local memory module (19) stores the processed data until successful transmission of the data to the database server is confirmed. The charging port (22) is controlled by the processor (16) to charge the local power supply (21).

[0187] Figure 3A configuration of a patient monitoring device is depicted. A housing or closure (26) includes components of the patient monitoring device. A first half (26a) of the closure can be snap-fitted into a disposable second half (26b) of the closure, which is bonded to an adhesive layer (30) that can be temporarily bonded to the patient's skin. In other examples, the closure can be heat welded or glued together, or can include a housing having a side opening and a side cover, or can include an assembly to which a fastener such as a screw is fixed, or can include a spring-loaded latch release on one side, or can include a connector having an internal thread on one side and an external thread on the other side. A tube connector (e.g., a standard Luer connector) can include a connection port (13) connected to a dialysate solution and a connection port (14) connected to an indwelling catheter. The connection port (14) for the catheter can be included in the closure (26). Between the connectors (13, 14) there is a fluid conduit (34) (e.g., a tube) that passes through a sensor network, which may include a plurality of non-fluid contact sensors (43) (e.g., light scattering / absorption sensors), fluid contact sensors (11) without moving parts (e.g., conductivity, impedance, and pressure sensors), and fluid contact sensors (1) with moving parts (e.g., Hall effect flow sensors). The gyroscope / accelerometer motion sensor (23) may be in a fixed position and separate from the fluid conduit of the fluid conduit (34). The sensors (1, 43, 11, 23) are connected to a printed circuit board (PCB). A control device (e.g., a microcontroller, firmware, memory storage module, wireless transmission module) (20) is also connected to the PCB. The control device (20) may be connected to each sensor via the PCB to power the sensor and output data from each sensor to the control device (20). For local power, a battery (32) may be connected to the PCB and the charging / communication port (22). A USB port (33) or other suitable port may be connected to an external power source and / or used as a wired communication channel. The control device (20) can be connected to the battery (32) and the charging port (22) via the PCB. The microcontroller, the memory storage module and the wireless transmission module are Figure 3 It is shown as being connected to a chipset, but can be a separate component connected via a PCB.

[0188] Figure 4An alternative configuration of a patient monitoring device is shown. A housing or enclosure (26) contains at least a portion of the patient monitoring device components. The connector includes a first connector (13) connected to a dialysate solution and a second connector (14) connected to a catheter. The second connector can be enclosed in the enclosure (26). Between the connectors (13, 14), a fluid conduit (34) can be connected to one or more non-fluid contact sensors (43) (e.g., light scattering / absorption sensors and optical cell counter sensors) and fluid contact sensors (11) without moving parts (e.g., conductivity sensors, impedance sensors, pressure sensors, pH sensors, temperature sensors). A gyroscope / accelerometer motion sensor (23) separated from the fluid conduit (34) can also be provided. A color sensor (24) can be placed directly above the skin surface through the catheter outlet portion, and / or a skin temperature sensor (25) can be placed directly on the skin surface. The sensors (43, 11) adjacent to the fluid conduit (34) are connected to a printed circuit board (PCB). The sensors (24, 25) sensing the skin surface are connected to the PCB via wires (35, 36) (e.g., flexible circuits). A control device (e.g., a microcontroller, firmware, a memory storage module, a wireless transmission module) (18) is also connected to the PCB. The control device (18) can be connected to each sensor via the PCB to power the sensor and output data from each sensor to the control device (18). For a local power supply, a battery (32) is connected to the PCB and a charging and / or communication port (33). For example, a USB port (33) can also be used as a connection to an external power source or a wired communication channel to access data. The control device (18) can be connected to the battery and charging port via the PCB. The microcontroller, the memory storage module, and the wireless transmission module are connected to the PCB. Figure 4 It is shown connected to a chipset, but can be a separate component connected via a PCB.

[0189] Disposable-Durable Parts Interface

[0190] exist Figure 3 and 4 In the variant shown, the sensor network is integrated with the rest of the hardware system and is embedded in a PCB that includes a battery (32), a control device (18), a charging port (33), connectors (13, 14) and a closure (26). Figure 5In another variation shown, a group of permanent or semi-permanent sensors (1, 43) are connected to the first closure half (26a). Another group of disposable sensors (11) (e.g., enzyme-based electrochemical sensors, test indicator strips) can be connected to the second closure half (26b), which also includes an adhesive layer (30) in contact with the patient. In this variation, the second closure half (26b) and the parts connected thereto can be referred to as cartridges. The replacement cycle of the adhesive layer can be consistent with the replacement cycle of the sensor, so that the cartridge can be replaced together. The two halves (26a, 26b) of the assembly can be detachably connected, for example, via snap-fit ​​fittings and / or electrical connectors. Different cartridges can include different configurations, such as different sensor packages. In some variations, the cartridge can include a closed housing so that the parts in contact with the fluid are sterile until the cartridge is properly loaded into the durable component interface (e.g., the first half (26a)).

[0191] exist Figure 3 , Figure 4 and Figure 5 In each of the variations depicted in the drawings, one or more components of the patient monitoring device (e.g., battery, memory, sensor, fluid conduit) may be removable to facilitate one or more of replacement, cleaning, data transfer, and charging. In some variations, redundant components may be provided, such as redundant batteries of the same or different capacity that serve as a "backup" power source in the event that the main battery has been depleted.

[0192] In some variations, the patient monitoring device can be two or more independent components that can be attached to each other to provide complete functionality. For example, a cartridge-based device can include a disposable cartridge that is configured to be removably attached to a durable component interface (e.g., a permanent closure / housing) of a patient monitoring device. The cartridge can include a set of fluid-contacting components (e.g., a fluid conduit, a fluid-contacting sensor), and the durable component interface can include a set of non-fluid-contacting components (e.g., a non-fluid-contacting sensor, a control device, a battery, a transmitter). In some of these variations, the fluid-contacting components can be removed and replaced as needed. For example, due to one or more of the time-varying regulatory requirements, biofouling, use, wear, degradation, and other changes, the fluid-contacting components of the patient monitoring device may need to be replaced. Similarly, if the patient only needs to use the device for a short period of time, replacing the fluid-contacting components allows multiple patients to safely use the device by replacing the fluid-contacting components. In some variations, the disposable cartridge can include two or more parts that can be removably attached to form a disposable component.

[0193] Additionally or alternatively, equipment, fluids and / or media such as ethylene oxide (EtO), autoclaves, solvent soaks, detergent soaks, etc. can be used to clean and disinfect one or more of the durable parts and cartridges of the patient monitoring device at predetermined intervals. For example, the cartridge can be configured to be cleaned, disinfected and reused at predetermined intervals instead of being processed. For example, the cartridge can be replaced or sterilized using an autoclave each time an infection is detected or every 28 days. In addition, between these replacement or sterilization steps, the cartridge can be cleaned with a fluid (e.g., acid, alcohol rinse) every day or week. In some variations, the durable parts can include a set of fluid-contacting parts and non-fluid-contacting parts. For example, the first and second connectors can be attached to the durable parts and can be connected to a fluid conduit of the cartridge that can receive a fluid.

[0194] Fluid conduit

[0195] Figures 16A-16C One variation of a fluid conduit connected to a printed circuit board is shown, which may include a set of sensors configured to determine one or more characteristics of a fluid flowing through the fluid conduit. Fig.16A A fluid conduit (34) (eg, constructed using molded PVC) is shown defining one or more apertures (70) covered by one or more corresponding sealing elements (49) (eg, silicone o-rings, adhesive, glue). Fig. 16B A printed circuit board (PCB) interface (1600) is shown, which includes a surface mounted device (SMD) sensor (2a) and a printed circuit board (PCB) mounting connector (2b). Fig. 16C In the embodiment of the present invention, a group of fluid contact sensors (44) are arranged in a corresponding group of holes (70). The SMD sensors (2a) can be sealed in the holes (70) via sealing gaskets (49) and compression fit with screws (45). The sensor terminals (2c) can be connected to the printed circuit board mounting connectors (2b). The SMD sensors (2a) can be non-contact sensors, for example.

[0196] Fig.16D shows a top cross-sectional view of a patient monitoring device such as a light scattering / absorption measurement system (1610), Fig.16EA side cross-sectional view thereof is shown. The system (1610) may include a spectral sensor comprising a group of light emitters (71) and light sensors (73). The group of light emitters (71) may be configured to transmit light into a fluid conduit (34). In some variations, a lens or filter (72a) may be disposed between the light emitters (71) and the fluid conduit (34). The group of light sensors (73b, 73a) may be oriented at respective predetermined light absorption angles and scattering angles relative to the group of light emitters (71). In some variations, a lens or filter (72b) may be disposed between the group of light sensors (73b, 73a) and the fluid conduit (34). As further described herein, the spectral sensor does not need to contact the fluid flowing through the fluid conduit (34), and the fluid conduit (34) may be substantially optically transparent (or nearly transparent, having a high total transmittance for the wavelength used in the measurement) so that the spectral sensor can measure the contents of the fluid conduit (34). In some variations, the fluid conduit (34) may define a set of apertures configured to retain a corresponding set of fluid contact sensors while maintaining a fluid seal (eg, with a sealing gasket (40)).

[0197] In some variations, the fluid conduit can have a circular cross-sectional shape. The fluid conduit can define a lumen (e.g., a lumen having a circular or square cross-section) in a rigid or semi-rigid material. In other variations, the fluid conduit can have any suitable shape. For example, Fig.17 A fluid conduit (15) of square cross-section is shown in a structure (71) (e.g., a housing) having holes configured to hold a set of fluid contact sensors (44) and holes for a light scattering / absorption sensor emitter (2b) and holes for a light scattering / absorption sensor detector (2a). The emitter (2b) and detector (2a) are shown oriented at 90 degrees to each other around the fluid conduit. Additionally or alternatively, the sensors can be molded directly into the structure (71) to ensure a fluid-tight seal. In some variations, an adhesive can be used to hold the set of sensors (2, 44) in the holes to ensure a fluid-tight seal. In some variations, a transparent layer can be provided between the sensor and the lumen. For example, a glass interface / section can be arranged between the sensor (2, 44) and the fluid in the fluid conduit (15). In some variations, the structure (71) can be constructed by one or more of, for example, injection molding, machining, ultrasonic welding, and 3D printing techniques.

[0198] In the systems and devices described herein including multiple sensors, the upstream sensor can be configured to change the properties of particles in the fluid conduit, thereby affecting the measurements performed by the downstream sensor. For example, a chemiresistor sensor can react chemically to particles, which may change, for example, the light scattering / absorption of the fluid in the fluid conduit. In another example, an optical sensor may include a light emitter that emits light in the ultraviolet wavelength range, which can kill cells and / or pathogens, thereby affecting the downstream optical measurements of cells and / or pathogens. Conductivity measurements by applying an electric current to the fluid may also damage cells or pathogens, thereby affecting the downstream optical measurements of cells and / or pathogens. In addition, conductivity measurements may also heat the fluid, which may change the temperature measurement downstream. In this way, in a sensor system with multiple sensors, the order of the sensors may be important. In particular, sensors that may react with the fluid and / or particles in the fluid conduit should generally be placed downstream so that their effects do not affect the measurements performed by the sensors in the system.

[0199] In some variations, for example in Fig.26 , 29 In the examples of and 30, where the fluid flow conduit passes through the patient monitoring device in one direction, one or more one-way valves (61) can be used to ensure that the fluid flow is restricted to the intended direction. When flowing in the direction opposite to the intended direction, the one-way valve (e.g., Qosina part number 80107 (Ronkonkoma, NY)) automatically seals. The check valve can be permanently installed on the patient monitoring device or can be used as a separate accessory. In addition to the Luer actuated valve, a check valve can also be used.

[0200] The sensor network can be configured to measure fluid flow into or out of a conduit. There are many configurations of sensors and fluid conduits. Figure 2 and 3 In one variation shown, there are one or more sensors in a single fluid conduit.

[0201] In another variation, Fig.26 As shown, the fluid conduit is bifurcated between the sensor fluid conduit and the infusion fluid conduit. When the fluid is infused from the tube set, the one-way valve (61a) at the junction (62) of the tube set prevents the fluid from entering the sensor fluid conduit (65). The infusion fluid all passes through the infusion fluid conduit (63) and then enters the catheter through the catheter junction (64). When the fluid is discharged from the catheter, the one-way valve (61b) at the junction (64) to the catheter prevents the drainage fluid from entering the infusion fluid conduit (63). The drainage fluid all passes through the drainage fluid conduit (65) and then enters the drainage line through the tube set junction (62). By isolating the infusion fluid conduit, the risk of infusing entrained pathogens into the patient is lower.

[0202] exist Fig. 27 and 28 In another variation shown, there are multiple parallel fluid conduits, wherein different sensors (1, 2) are located on different fluid conduits. For example, for multiple optically based sensors, it may be necessary to isolate the sensors to minimize interference between the sensors. Between each fluid conduit, there may be electrical and / or optical shielding materials to isolate the sensors. Each fluid conduit may also have a unique cross-sectional area. In the case of a sensor based on a chemiresistor mechanism, a longer fluid retention time is required, and the cross-sectional area of ​​the measuring channel may be smaller (e.g., a diameter of about 100 to 500 μm) to reduce the flow rate by reducing the lumen and causing an increase in back pressure. Fig. 27 and 28 A fluid conduit (15) is shown split into three fluid conduits (66, 67, 68), wherein sensors (1, 2) monitor each fluid conduit. After flowing through the three fluid conduits, the fluid reconverges into a fluid conduit (69) connected to the conduit. Fig. 27 The direction of fluid flow is shown, wherein the arrows show the infusion of fluid into the catheter, Fig.28 Fluid flow directions are shown, with arrows illustrating fluid exiting the conduit.

[0203] exist Fig.29 and 30 In another variation shown, a one-way valve (61) may be used so that only the infused or exiting solution is measured by sensors in one or more fluid conduits. Fig.29 and 30 A fluid conduit (15) is shown, which is divided into three fluid conduits (66, 67, 68), each of which is monitored by a sensor (1, 2). The fluid conduits are reunited into a fluid conduit (69) connected to the conduit. A one-way valve (61) is provided between the fluid conduit (15) and the fluid conduit (69). Fig.29 Depicted are the directions of fluid flow, with arrows showing the infusion of fluid into the catheter. Fig.30 The direction of fluid flow is depicted, with arrows showing fluid exiting the catheter. During the infusion state, the one-way valve (61) prevents fluid from flowing into the fluid conduit (68), but when fluid exits the catheter, the one-way valve allows fluid to flow into the fluid conduit (68). An example of this mode of operation is during the use of an active sensor that may react with the fluid (e.g., an enzyme-based electrochemical sensor) that produces byproducts from the enzymatic reaction, the system can prevent this byproduct from entering the patient's body and will only be activated when the fluid leaves the patient's body.

[0204] In another variation, the device is in contact only with the drainage fluid. Fig.31This is depicted in the most basic configuration.The drainage line is attached to a main conduit (15) which passes through the patient monitoring sensors (1, 2) and exits to a waste container.

[0205] In another variation of the device connected to the drainage line, Fig.32 A fluid conduit is depicted. The drainage line is attached to the main drainage conduit (15), and a valve (72) diverts the flow to one or more sensing channels (73), while the remaining fluid continues to flow through the waste channel (65). After the fluid flows through the sensing channels, the sensing fluid channels can be reconnected to the main drainage conduit (65). Alternatively, after the fluid flows through the sensing channels, the sensing fluid channels can drain directly to a waste container.

[0206] Cartridge

[0207] 6 and 7 illustrate examples of patient monitoring devices including a cartridge loading mechanism. Fig. 6A and Figure 6B A top view and a front view of a durable component of a patient monitoring device without a loaded cartridge are depicted. A recess (e.g., track) (37) is provided, which is configured to couple with a cartridge (not shown). In some variations, a switch (38) may be disposed in or near the recess (37).

[0208] Figure 6C and 6D A top view and a side view of a patient monitoring device loaded with a disposable cartridge (40) are shown. Loading the cartridge (40) into the recess (37) may activate a switch (38) configured to transmit an installation signal. Fig.6D As shown, a locking mechanism, such as a set of spring-loaded flanges (39), may be configured to push toward the cartridge (40) and hold it in place. Figure 6C As shown, a set of fluid contact sensors (44) can be advanced toward the cartridge (40) during loading, thereby allowing the sensors (44) to contact the fluid flowing through the fluid conduit of the cartridge (40). In some variations, a visual indicator (41) can be provided to indicate the status of the cartridge. For example, the indicator (41) can be red when the cartridge is not loaded (e.g., switched to OFF) or is not loaded correctly, and can be green when the cartridge is loaded correctly (e.g., switched to ON).

[0209] As another example, Fig. 7AA top view and a front view of a patient monitoring device without a loaded cartridge (40) are depicted. A durable component defining a recess (e.g., a track) (37) may include an electrical connector (42) configured to couple to the cartridge (40). In some variations, the cartridge (40) may include a printed circuit board and a connector (45) configured to mate with the electrical connector (42) of the durable component. A non-fluid contact sensor (43) is located in a reusable module, while a fluid contact sensor (44) is located in a disposable cartridge. In this example, all fluid contact components, including the sensors, are part of the disposable cartridge (40).

[0210] The components may be fitted together by a number of mechanisms. For example, the components may be held together by a set of latches, a set of magnets and magnetic counterparts, screws with threaded holes, nuts that hold the parts together by pressure, combinations thereof, and the like. Additionally or alternatively, one or more components may be twisted into each other and sealed like a Luer lock, or locked into each other by a shaft lock, frame lock, bushing lock, or lock-back mechanism that may be released by pushing a lock, a separate button, or other securing device. The interfaces listed above are inclusive examples, and other interfaces may be used to secure the components together for use.

[0211] The parts can be released from each other by pressing a button on the locking structure, but other mechanical and / or electrical devices can be used instead. One method of releasing the disposable part from the durable part is through a user interface on a patient monitoring device or on a stand-alone mobile phone, tablet computer, or browser-based user interface. Due to automatic prompts, prompts from health care providers, or through their own agency, patients can choose to replace disposable cartridges. After the operation, the cartridge will be released or unlocked and can be removed from the durable part of the device. Alternatively, the equipment manufacturer, health care provider, or employees of a third-party service can be prompted to replace the disposable part. The employee may have a special key, which may be physical or electronic, to unlock the device and release the durable part. In this way, the patient will not have any interaction with the inside of the device. A combination of patient and health care provider permissions can also be used to facilitate the replacement of cartridges. An example is that a health care provider prompts the patient to replace the disposable part, and sends a verification code to the patient through their personal data on the only application of the device, and then enters the verification code into the device physically or digitally, thereby unlocking it. In some variations, the disposable part can be automatically unlocked under predetermined standards such as regulatory requirements, time, use, wear, biofouling, etc.

[0212] In some variations, one or more of the cartridge and durable component may be disabled under predetermined conditions. For example, if one or more sensors lose calibration due to bacterial fouling, low battery, or a predetermined time interval, one or more of the cartridge and durable component may receive a signal to disable patient monitoring.

[0213] Sterility

[0214] Any cartridge described herein can be configured to maintain the sterility of its fluid channel between manufacturing and installation. In some variations, the end of the fluid channel of the cartridge can be sealed with a film to maintain the sterility of the fluid channel. The film can be composed of silicon, hydrogel, polyvinyl alcohol (PVA), a combination thereof, etc. In some of these variations, a fluid conduit can be inserted into the lumen of a connection port (e.g., a tube connector), wherein the connection port is configured to be fluidically connected to a dialysate solution or an indwelling catheter. In these variations, the film can remain intact until the fluid flows through the connection port for contact. For example, the fluid flowing through the connection port can contact and then dissolve the film (e.g., a PVA film), thereby connecting the fluid conduit fluid to the connection port. Additionally or alternatively, the film seal can be destroyed by applying enough external force (e.g., squeezing the fluid channel) to the end of the fluid conduit. In other variations, one end of the connection port can be inserted into the lumen of a fluid channel sealed by a group of films, thereby piercing the film seal, and the fluid conduit fluid is connected to the connection port.

[0215] In some variations of disposable cartridges, the fluid channel material may be constructed of a material with known fouling characteristics that is factored into the sensor readings affected by fluid channel clarity to calibrate the sensor readings. Manufacturer calibration may form the initial calibration and then test cycles may be used to observe how fouling develops over time for a particular individual. Thereafter, typical fouling dynamics may be known and accounted for. The device may record metrics such as the total time the material in contact with the fluid has been in the device and the total fluid that has been in contact to refine fouling corrections and determine how often disposable components should be replaced.

[0216] In one variation, materials with high antifouling properties (e.g., polysiloxanes coated with polyethylene glycol (PEG) and polysiloxanes coated with hydrogels, polyurethanes coated with zwitterions (phosphorylcholine, sulfotrimethylammonium betaine), polyvinyl chloride (PVC) coated with polyethylene oxide, and amphiphilic polysiloxanes) can be used to maintain consistent optical clarity during use. Antifouling materials can be incorporated into one or more fluid-contacting components of a patient monitoring device (e.g., fluid channels, connector tubes, sensor interfaces). For example, a sensor can include a fluid flow sensor that includes a Hall effect sensor and a rotating turbine that at least partially includes an antifouling material. The antifouling material can reduce clogging and resistance of the rotating turbine.

[0217] Sensor Infection Prevention

[0218] All components of the fluid connected to the catheter are designed to avoid or reduce potential infection transmission. For example, the sensor surface in contact with the infusion fluid and any accessories or connectors can be configured or selected to minimize the space or surface area in which bacteria or biofilms can accumulate. For example, the flow sensor can be constructed or selected to utilize ultrasonic or optical measurements without moving parts, as opposed to Hall effect sensors that have rotating or other movable sensor elements in contact with the infusion fluid. However, Hall effect sensors can be used that include antimicrobial surface treatments (e.g., silver coatings) and have all fluid flow cavities without any static fluid. Hall effect sensors can also be used in situations where fluid is only discharged from the catheter and never enters the patient's body.

[0219] The sensor material can be selected so that the contact surface is corrosion resistant and biocompatible. In one example, borosilicate glass can be the interface between the dialysate and the infrared sensor. The hardware system includes materials that can be sterilized by common aseptic methods such as steam sterilization, chemical soaking (e.g., isopropyl alcohol), ultraviolet (UV) germicidal radiation, electron beam, or gamma radiation. In one use case, during a prescribed maintenance period, the patient sterilizes the hardware sensor system using a commercially available home steam sterilization unit or chemical sterilization in the docking system described herein.

[0220] In other variations, the fluid conduit can be constructed of materials that are susceptible to bacterial and / or other biofouling / contamination to promote a reduction in light received by the light scattering / absorption sensor. This can facilitate one or more of cleaning, disinfecting, and replacing the fluid conduit at predetermined intervals. In some of these variations, one or more portions of a patient monitoring device that include biofouling susceptible materials can be replaced when a patient infection is detected. This can allow the system to "reset" and monitor the progression of a patient infection or detect a new infection. Contamination / fouling materials include high surface energy materials, polycarbonate, nylon, polyethylene terephthalate (PET).

[0221] Materials can also be designed to be cleaned frequently. Materials with high hardness and solvent resistance, such as quartz, borosilicate, or sapphire glass, can be used for abrasive and / or solvent cleaning. Other materials with high lubricity and solvent resistance, such as fluoropolymers (FEP, PTFE), can be used to clean by flushing with solvents and / or light abrasion.

[0222] Housing and mounting for patient monitoring equipment

[0223] The patient monitoring device described herein may include a housing (e.g., closure) that can be varied based on application and patient needs. For example, the closure of the patient monitoring device may be flexible, rigid, or both, and include components having different flexibility and / or rigidity. For example, a closure for a patient monitoring device worn by a patient may include one or more components that are flexible in nature to accommodate movement of the contact skin area, improve the patient's comfort, and reduce stress on the adhesive. These components of the closure may be made of flexible materials such as polysiloxane, thermoplastic polyurethane (TPU), etc. (e.g., injection molding, machining, 3D printing). The closure may also include a rigid base material overmolded with one or more flexible materials, such as polycarbonate and acrylonitrile-butadiene-styrene (ABS). The housing may include a mounting structure configured to be attached to a structure such as a drainage container or a patient.

[0224] In some variations, the closure described herein can be coupled to the patient in a variety of ways. In one example, the closure is attached to the patient's skin via an adhesive. The double-sided adhesive layer can include a specific adhesive that engages with the closure, and a different adhesive that engages with the patient's skin. In one example, the closure can include a polysiloxane wall, or include a polysiloxane outer layer. The adhesive can be a polysiloxane adhesive, such as the Silastic medical adhesive of Dow Corning (Midland, Michigan). Various adhesives can be used on the skin surface side, including hydrocolloid adhesives, which can fully seal the skin surface for 2-4 weeks. The adhesive can be replaceable and can be carried out in a time period that matches the maintenance cycle of battery charging, cartridge replacement, cleaning / disinfection cycle, patient infection detection, combinations thereof, etc.

[0225] Such as the above and Figure 3 Closures such as the closures shown may include one or more components and openings. To protect internal hardware components under various environmental conditions, the closure design may include seals (e.g., silicone gaskets) between components that provide a watertight seal / watertight seal. To reduce optical noise from optical-based sensors (e.g., spectral sensors, light scattering / absorption sensors, color sensors), the closure design may also include a light-shielding structure, such as an opaque colorant added to the original closure material, or a reflective paint on the outer surface, sub-section, or the entire closure. To allow a user to detect air or liquid leaking into a fluid conduit, the section of the closure surrounding the fluid conduit line may be optically transparent or translucent.

[0226] exist Figure 3 , Figure 4 and Figure 5In the illustrated variation, the closure may close off a port (14) (e.g., a connector) connected to the catheter except at the catheter exit site where it leaves the patient's skin, which may provide protection from infection at the catheter exit site. Typically, the port (14) may be connected to the closure via a tube, but in other examples, the port (14) may be integrated into the wall of the closure. The patient monitoring device may alternatively have two port ends extending from the closure, e.g., at Fig.18 In the described variation. Fig.18 An alternative variation of the patient monitoring device form factor is depicted in which the closure has two exposed ports for fluid conduits on the exterior of the closure body. One port (58) is connected to a conduit (not shown) and the other port (60) is connected to an infusion / drainage fluid tubing port (not shown).

[0227] exist Fig.14 In another variation described, the patient monitoring device is arranged to replace a conventional transfer set for quick connection of a tubing set for peritoneal dialysis treatment. Thus, the patient monitoring device described herein may be referred to as a "smart" transfer set.

[0228] In another variation, the patient monitoring device described herein can be arranged to replace a conventional drain line for draining fluid to a disposal container. In some of these variations, the patient monitoring device can include a section of tubing connected to a CCPD or CAPD. The tubing can be used for one or more drainage cycles. Therefore, the patient monitoring device described herein can be referred to herein as a "smart" drain line.

[0229] exist Fig. 20A In another variation described, the patient monitoring device (301) can be clamped onto a sensor portion of a fluid conduit (34) (e.g., a tube set, a connector tube). In some variations, one or more portions of the fluid conduit (34) can include a sensor portion (302) and a tube connector (34). In particular, the patient monitoring device (301) can be configured to be clamped onto the sensor portion (302) to measure one or more properties of the fluid without direct fluid contact. For example, the patient monitoring device (301) can include one or more sensors configured to measure one or more parameters, such as fluid light scattering / absorption, fluid temperature (via infrared sensing), and fluid pressure (via expansion of the sensing area material). In some variations, the sensor portion (302) can include an optical grade polysiloxane (NusilMED-6033) having a thin wall (i.e., 0.020 inches) that can be molded together with the fluid conduit (34).

[0230] In some variations, a patient monitoring device may be clipped onto a conventional tubing set and configured to pierce a fluid conduit such that the patient monitoring device may be in direct contact with fluid in the fluid conduit. Fig.21A A variation is shown in which a set of punch holes (303) may be cut into the sensor portion (302) of the channel (34) for the fluid conduit (34). Fig. 21B As shown, the patient monitoring device (301) may include a set of protruding sensors (304) that may be configured to align with the punched holes (303). Fig. 21C As shown, the protruding sensor (304) can also be configured to penetrate the punch hole (303) when the patient monitoring device (301) is clamped on the sensor portion (302) of the fluid conduit (34) with a predetermined force. In this way, a set of sensors (304) of the patient monitoring device (301) can directly contact the fluid in the fluid conduit (34) while maintaining a fluid seal.

[0231] In some variations, two of the protruding sensors (304) may include electrodes configured to measure fluid conductivity, and the third sensor may include a pressure sensor. In other variations, one or more sensors (304) may include a temperature sensor. In some variations, the sensor portion (302) may not include a set of engraved punch holes. In some variations, the set of protruding sensors (304) may include a set of protrusions configured to penetrate the wall of the sensor portion (302). For example, the set of protrusions may include a set of sharp needle-like ends. In some variations, the sensor portion (302) may be made of a rigid material such as PVC or nylon, which can be easily pierced using the protrusions.

[0232] In another variation, the patient monitoring device may be configured to be worn in a pocket with a separate strap, drawstring loop, or temporarily secured in place with tape. Fig. 22 An alternative form factor for a patient monitoring device is depicted, wherein the housing (26) is cylindrical, with Fig.18 The variant shown has a reduced footprint in comparison and has two connection ports (13, 14) on the outside of the closure.

[0233] exist Fig.23A and 23BIn another variation described in a cutaway perspective view of , the patient monitoring device (2300) may include a housing (400) having a mounting clip (401) designed to be attached to a drainage container such as a toilet, a drain pan, a trash can, a trash bag, a bathtub, etc. A tube set drainage line (402) may be connected to an inlet connector (403). After the fluid passes through the patient monitoring device (2300), the fluid may be discharged through the drainage line (402), which may have a connection point (405) to the mounting clip (401). In other variations, the patient monitoring device (2300) may be coupled to the drainage container by any suitable means, such as by a hook, a strap, an adhesive, a clamp, a magnetic attachment, a combination thereof, etc. In some of these variations, a user may connect a drainage tube from an existing circulation device to the device inlet connector (403) by any of a barbed, luer, compression, or similar fitting. The fluid conduit (34) can extend through a set of sensors (2a) and through the housing (400), through a tube section connected to a mounting clip (401), to drain the fluid into a drainage container such as a toilet, drain pan, trash can, trash bag, bathtub, etc.

[0234] Fig.24A and 24B A variation of a patient monitoring device (2300) attached to the side of a toilet (2400) is depicted. A standard Luer-type connector (regular or large bore) can be used as an interface for the patient monitoring device flow line to the existing Luer-type connectors of most catheters, as well as the Luer-type connectors of the connector tubing for most infusion drug solutions or drainage bags. In another example, a barb fitting can be used. However, in other examples, a different or proprietary connector interface can be used.

[0235] In a variation, one may use Fig.25A and 25B The threaded connector shown is used as a universal connector to connect to drainage lines of various manufacturers. For example, the first connector (407) can include threads (409) configured to mate with the inner diameter of the drainage line end (408) of the second connector (410) by being screwed onto the drainage line to achieve a leak-free assembly. The size of the first connector (407) can be determined as follows: Fig.25A The predetermined inner diameter of the tube shown, or by Fig.25B The tapered design shown scales to multiple tube sizes.The first connections (407) may be coupled to inlet / outlet connections of a patient monitoring device.

[0236] In some variations, one or more fluid conduit connectors of a patient monitoring device may include a Luer-activated valve. The valve may be opened to allow fluid flow when an indwelling catheter or connector tube is connected, and may be closed to seal liquid and air when the indwelling catheter or connector tube is disconnected. A Luer-activated valve (e.g., Qosina part number 80114 (Ronkonkoma, New York)) is bidirectionally self-sealing when not connected, and is activated when the rod of a male Luer lock is connected to allow fluid to flow in either direction. The valve may be permanently attached to a patient monitoring device, or used as a stand-alone accessory, which allows for removal during system sterilization and easy replacement during maintenance cycles.

[0237] Test indicator strip

[0238] In some variations, the disposable cartridge of the patient monitoring device may include a set of test indicator strips. The test indicator strips may be disposable or have a limited number of uses, wherein the system monitors the number of uses before indicating replacement or sending a replacement signal. In some variations of test strips that only provide positive reactions, the test strips may be used until a positive reaction is obtained or until the nonspecific binding of particles to receptors reaches a predetermined nonspecific binding threshold (e.g., 30% of receptors). For example, the nonspecific structural threshold may correspond to a predetermined volume of drainage fluid flowing through the set of test strips. Assuming that no positive reaction occurs, the set of test strips may be used continuously until, for example, a fluid flow sensor detects a predetermined volume of drainage fluid. In some variations, a control device (e.g., a processor) of the system may analyze the fluid flow generated by the fluid flow sensor to generate a signal indicating that the set of test strips should be replaced. As described in more detail herein, an optical reader may be used to read the set of test strips.

[0239] In some variations, the test indicator strip can detect specific solutes that will indicate complications (e.g., leukocyte esterase for general infection, pH for urinary tract infection, hemoglobin for bleeding). The test strip can be based on methods such as immunoassays (e.g., ELISA) or enzymatic assays. The test strip can be used in conjunction with other sensors in the device. For example, the sensor can indicate when the fluid flow begins and will activate the test strip, thereby coordinating the time for subsequent analysis of the test strip. For example, when the pressure sensor and / or flow sensor detects that the fluid flow through the fluid conduit corresponds to the fluid flow through the test strip, the control device can start the test strip timer, which is configured to indicate the time when the test strip is ready for analysis. The test strip can be optically analyzed by one or more optical readers (e.g., color sensors for colorimetric determination) connected to the fluid conduit and the test strip, and the user can observe the test strip through an optically transparent area (e.g., a sensing window) in the fluid conduit.

[0240] Fig. 8A and 8C A variation of the device is depicted in which a disposable test strip is used to assess the presence and / or concentration of a particular solute. In some variations, a set of test strips contained in a removable sensor can be removably attached to a disposable cartridge that includes a fluid conduit. The test strip (46) is secured to the cartridge (47) and is in direct contact with the fluid being analyzed. For example, the cartridge (47) can be removably attached to a cartridge having a fluid conduit (48). For clarity, the test strips are not shown in FIG. Fig. 8A Only the fluid conduit (48) of the disposable cartridge is shown. Fig. 8A As shown, the cartridge (47) can be inserted through a sealing gasket (49) disposed in the wall of the fluid conduit (48), which allows the cartridge (47) to be replaced at a different frequency than the fluid conduit (48) and the corresponding disposable cartridge. Figure 8B A durable component is shown coupled to a fluid conduit (48) of a disposable component. Figure 8B As shown, when the cartridge (47) is not attached to the fluid conduit (48), the indicator light (134) can indicate the attachment status of the cartridge (47) (e.g., red corresponds to an unattached cartridge status, and green corresponds to an attached cartridge status). The recess (135) can be configured to accommodate the test strip module (47). Figure 8C As shown, when the cartridge (47) is attached to the fluid conduit (48), the indicator light (134) can indicate the attached cartridge status (e.g., a green light), wherein the set of test strips (46) is inserted into the fluid conduit (48) through the sealing gasket (49).

[0241] In another variation, Fig.68A -D The disposable fluid conduit (6830) described above can integrate the test strip into the lumen. Therefore, the test strip will become part of the disposable component, which can be easily replaced.

[0242] Some test indicator strips have specific exposure times, and in some variations, a set of test strips may be exposed to only a portion of the test fluid volume and analyzed at a specific time after exposure to the fluid. For example, Siemens' Multistix 10SG reagent strips may optionally read glucose and bilirubin tests at approximately 30 seconds after exposure, ketone tests at approximately 40 seconds after exposure, specific gravity tests at approximately 45 seconds after exposure, pH tests, protein tests, urobilinogen tests, blood tests, and nitrite tests at approximately 60 seconds after exposure, and white blood cell tests at approximately 2 minutes after exposure. The exposure step, delay / incubation step, and reading step may be performed by the device, the user, or a combination of the two. For example, an audible alert (e.g., a beep, sound / noise) may be output to the user when one or more test strips are ready for visual analysis.

[0243] Luminescence or color change are two possible readouts of the test strip, which can be measured by the user or by an optical instrument (e.g., Siemens' Clinitek Status+Analyzer). Alternatively, the optical test strip reader can be integrated into the patient monitoring device (e.g., durable component, disposable cartridge), or as a stand-alone, removable optical sensor.

[0244] Exposure and reading of test strips using the systems and devices described herein can provide system monitoring and provide more sensitive and consistent analysis of test strips (e.g., optical read results and non-optical read results (e.g., chemical byproducts)) than patient-provided analysis. Test indicator strips may not be used for every fluid test, but only when there is suspicion of complications indicated by another sensor. For example, if the light scatter / absorption data indicates that the light scatter / absorption level has reached a peak, one or more test indicator strips can be used to detect the presence of white blood cells or blood to determine the specific source of the light scatter / absorption. For example, exposure can occur automatically using a patient monitoring device, or by the patient himself by inserting a test strip into the solution as the solution leaves the drainage line.

[0245] A set of test strips can be provided in a cartridge (e.g., a test strip module) that can be removably attached to one or more of a patient monitoring device and / or a disposable component. In some variations, the cartridge can be removably attached to a disposable component (e.g., a cartridge), and the disposable component can be removably attached to a durable component of a patient monitoring device. In some variations, the device can automatically replace the test strips in a loaded cartridge, thereby reducing the need for replacement and intervention of the patient monitoring device by the patient. Figures 9A-9D One variation of a cartridge (900) is shown that includes a set of test strips (46). Fig.9A In the embodiment of the present invention, a first subset of test strips can be arranged in a first position (902) where the test strips are stored and ready to be exposed to a fluid flow. A second subset of test strips can be arranged in a second position (904) where one or more test strips can be pushed into and out of the cartridge (900). The cartridge (900) can define one or more openings (e.g., test strip slits) configured to push the second subset of test strips out of the cartridge (900). For example, the test strips (46) can be inserted into the cartridge (900) by contacting the cartridge (900) with the test strips. Fig. 8A and 8CThe test strips (46) are ejected from the cartridge (900) in a manner similar to that shown in the figure, and pass through one or more gaskets in the wall of the fluid conduit (not shown), and subsequently contact the fluid flowing in the fluid conduit. In some variations, the group of test strips (46) in the second position (904) can be exposed to half or less of the width of the fluid conduit to reduce the effect of laminar flow of the group of test strips (46) on the fluid conduit.

[0246] After the set of test strips in the second position (902) has been used, the set of test strips (46) in the second position (902) may be retracted into the cartridge (900), such as Fig. 9B The entire set of test strips (46) can then be moved toward the third position (906) ( Fig.9D )Advance Fig. 9C ), thereby aligning an unused set of test strips (46) with the second position (904). Fig.9D All test strips (46) are shown to have been used and advanced to the third position (906) and are ready for replacement. In some variations, the cartridge (900) may include one or more springs (not shown) configured to push a second subset (900) of test strips into and out of the cartridge (900). In addition, the group of test strips (46) may be coupled to a movable track in the cartridge (900). The track (not shown) may be coupled to a chain and gears configured to incrementally / progressively advance the test strip group (46) toward the third position (906). In some variations, one or more of the springs and tracks may be coupled to a control device for a motor and a durable component of the patient monitoring device.

[0247] In some variations, a test strip reader (if a durable component or a disposable component) can be located near the fluid conduit to read a test strip held in the second position (904). In some variations, the test strip reader can be disposed between an outer surface of the fluid conduit and a surface of the cartridge (900) so that the test strip reader can read the test strip (46) when the test strip (46) is retracted into the cartridge (900). In other variations, the test strip reader can be disposed in the cartridge (900) and configured to read a test strip (46) in a retracted cartridge (900) in a third position (906).

[0248] In some variations, one or more test strips can be directly integrated into a disposable fluid line or drainage container. For example, one or more test strips can be arranged along the inner wall of a connector tube (e.g., fluid line, drainage line) and a drainage container. Peritoneal dialysis can include a disposable drainage line and a container, which can be replaced at predetermined intervals (e.g., after each replacement cycle, every day). A test strip reader can be coupled to (e.g., clamped to) a connector tube and / or a drainage container, and configured to read a test strip. The fluid flowing through the connector tube and / or the drainage container may contact a test indicator strip and be read by a test strip reader. When the test strip reader is removed, the connector tube and / or the drainage container can be discarded after use. The connector tube and / or the drainage container can include a material with high optical transparency, such as polysiloxane, PVC, polyurethane, and nylon, which can be molded or otherwise formed. In some variations, the test strips can be connected to the inner wall of the connector tube and / or the drainage container using one or more of adhesives, injection molding processes, ultrasonic bonding, laser bonding, etc. In some other variations, a group of test strips can be arranged in a separate conduit (e.g., a fluid conduit and / or a container) connected to the connector tube and / or the drainage container. The conduit can be connected to one or more of the patient monitoring device, the connector tube, and the drainage container. The fluid flow entering the conduit can be controlled. For example, the conduit can be connected to one or more of a valve, a permeable membrane, and a soluble obstruction (e.g., polyvinyl alcohol). The valve can be controlled by a user and / or a patient monitoring device.

[0249] In one variation, Fig.12 An optical reader (52) is shown coupled to the inner wall of a drainage container (57). In this configuration, the container (57) and the reader (52) can be discarded together. In some variations, the optical reader (52) can be coupled to the inner wall or tube of the container (57) in the same manner as a test strip (e.g., adhesive, injection molding, ultrasonic bonding, laser bonding). In some variations, the optical reader (52) can include a battery, a processor, a memory, and a wireless transmitter, and can process and send sensor data in a manner similar to the patient monitoring device described herein. The optical reader (52) can form a wired connection to a patient monitoring device (not shown) for data communication and / or control.

[0250] In other variations, one or more test strips may be arranged in a self-contained test strip module that is connected to an inlet and / or outlet of a patient monitoring device and / or disposable tubing. A self-contained test strip module allows the test strips to be flexibly connected to various tubing sets from different manufacturers at different locations. Patient monitoring devices may also be replaced at a different frequency than other components of the system. Fig. 10AA variation is depicted in which a set of test strips (46) are attached to the internal fluid flow conduit of the test strip module (1000). The inlet connector (50) or the outlet connector (51) can be mated with the connector tube (1010). The connectors (50, 51) can be one or more of a barb type, a standard quick release type, a universal Luer type connector, and a conventional connector type. The system is Fig. 10B Assembled to the tube, Fig. 10C It is shown assembled with a clamp-on test strip reader (52).

[0251] Fig.11A and 11B Another variation of a clamp-type test strip reader having a test strip is shown. Fig. 11B is a perspective view of a patient monitoring device (301), such as a test strip reader, which may include one or more sensors configured to read a set of test strips (302) sandwiched therebetween. Fig.11A A sensor portion (302) of a fluid conduit (34) (e.g., a drainage tube) is shown. For example, the sensor portion (302) may include a set of test strips aligned with an optically transparent window for allowing a clamp-on optical reader (301) to measure the set of test strips. The patient monitoring device (301) may be configured to be clamped onto the sensor portion (302) to read the color of the set of test strips (302).

[0252] Sensors for infection detection

[0253] Indwelling patient catheters are susceptible to infectious complications. In the case of peritoneal dialysis patients, indwelling catheters are used to infuse and drain dialysate solutions, and peritonitis is a common complication. In the example of peritoneal dialysis patients, infection detection can be monitored with at least one patient infection detector (e.g., one or more sensors) configured to measure suitable parameters including, but not limited to, patient core body temperature, patient skin temperature, draining dialysate pH, draining dialysate light scattering / absorption, draining dialysate leukocyte count or activity, draining dialysate lactate content, and skin discoloration at the catheter exit site (e.g., due to a rash), etc.

[0254] Clinically, one sign of infection is a fever. Body temperature is usually between 36.1 and 37.2°C. Temperatures above this range indicate a fever. For temperature monitoring, infrared sensors, thermocouples, or thermistors can be used to monitor the skin surface, or in the case of peritoneal dialysis patients, sensors can directly measure the drain dialysate solution as soon as it leaves the body.

[0255] A thermistor is typically a two-terminal semiconductor device made from a semiconductor material whose resistance varies non-linearly with temperature. Fig.33 A circuit design for a thermistor is depicted in which power (74) is provided by a microcontroller to a sensor (75) positioned so that the sensing surface is in direct contact with a fluid conduit (15) for optimal heat transfer, and the sensor outputs a voltage (76) to the microcontroller. In a thermistor, a change in temperature results in a change in resistance, which results in a change in voltage output.

[0256] When thermistors are used in peritoneal dialysis patients, the thermistor sensor can be positioned to measure the dialysate drainage fluid flow catheter just leaving the catheter / body, which will allow reading of the draining dialysate solution flowing directly out of the body. After being indwelling in the abdomen for a long time, the temperature of the drained dialysate should be equal to body temperature. However, depending on the distance between the thermistor location and the body, which is primarily determined by the length of the indwelling catheter extending outside the body, temperature compensation may be required to account for the loss or increase of heat. For example, a stand-alone ambient temperature sensor and a fluid flow meter can be used in conjunction with a fluid temperature sensor. By measuring the flow rate and ambient temperature, heat loss can be estimated with reasonable accuracy. As an alternative to compensating the thermistor value based on heat loss in the tube and using the temperature value in absolute terms, a relative temperature change of the measured temperature of the draining dialysate measured over time can be used.

[0257] In another approach, the thermistor can also be placed directly against the skin to measure the skin surface temperature to monitor patients using various catheter types. In this use case, the thermistor can be supported by a fixed closure to allow pressure to push the sensing surface against the skin to achieve optimal heat transfer. In addition to monitoring the onset of infection, temperature measurement can also provide feedback on the patient's response to infection treatment. For example, when an infection is detected, antibiotic treatment can be prescribed to the patient. The patient's body temperature changes can be monitored during treatment as a method of evaluating the effectiveness of antibiotic treatment.

[0258] Light scattering / absorption measurements of fluid exiting the catheter can also be used for infection detection. In the case of peritoneal dialysis patients, the fresh dialysate delivered to the patient is a clear solution prior to introduction into the body. After the dialysate solution is drained, a turbid dialysate solution can indicate an infection, particularly peritonitis. White blood cells (also known as leukocytes) concentrate in areas of infection and mix in the dialysate during peritoneal dialysis, resulting in a turbid draining dialysate solution. The system can utilize a spectral sensor (e.g., a light scattering / absorption sensor) to analyze the infused and draining dialysate solution as a method of detecting infection in a patient.

[0259] Light scattering / absorption sensors are used to quantitatively measure suspended particles in a fluid. This is done by measuring light scattering and / or light absorption caused by suspended solids in the fluid. In particular, light scattering / absorption measurements can be used to determine the particle composition of a fluid. As used herein, light scattering / absorption can mean light absorption or scattering at a specific wavelength or range, which can give different signals based on the substance.

[0260] Fig.34 An exemplary infrared light scattering / absorption sensor is depicted. A microcontroller provides power (74) to a light emitter (86) and a detector (84). The emitter (86) transmits light through a fluid interface (92) and a fluid conduit (15). The detector (84) detects the scattering of the transmitted light and outputs a corresponding voltage (80) to the microcontroller based on the amount of light detected. Fig.34 As shown, the emitters and detectors are oriented 180 degrees apart around the circumference of the fluid conduit (15), but the emitters and detectors may also be oriented at other forward scattering angles (>90 degrees), side scattering angles (90 degrees), or back scattering angles (<90 degrees). To increase the specificity of the detected particles, multiple emitter / detector systems may be used to use other light absorption and scattering patterns at different wavelengths and / or scattering angles based on the unique absorption and scattering patterns of different particle types (cellular and non-cellular).

[0261] The fluid conduits, light emitters, and detectors may have various configurations. Figures 78A-78D A change in orientation is depicted, wherein at least one detector (e.g., photosensor) (7802) is oriented along the longitudinal axis of the fluid conduit (7803). The light emitter (7801) can be oriented closer to the distal end (7805) of the fluid conduit (7803) ( Fig.78B ), or closer to the proximal end (7804) of the fluid conduit (7803) ( Fig.78A ). One or more detectors (7802) may be oriented radially around the fluid conduit (7803). To align the light emitter (7801) longitudinally with the fluid conduit (7803), the fluid conduit (7803) is shown bent 90 degrees, but other angles or embedded cavities may be used to position the light emitter (7801). Fig.78A and 78B A portion of a fluid conduit (7803) having a single bend is depicted, and Fig.78C and 78D A fluid conduit (7803) is depicted having bends on either side of the detector (7802). Fig.78C In the embodiment, a pair of light emitters (7801) are aligned along the longitudinal axis of the fluid conduit (7803) on either side of the detector (7802).

[0262] In some variations, the accuracy of the optical signal measurement can be improved by reducing the presence of air bubbles (micro and larger) that adhere to the surface of the fluid conduit during measurement. Some variations of the fluid conduit can include one or more hydrophilic materials configured to prevent air bubbles from adhering to the conduit surface, and a filter can be placed upstream of the optical sensor device. For example, the filter can be an air filter, such as a hydrophilic filter (Qosina, part number 28216).

[0263] Additionally or alternatively, a pressure differential in the fluid conduit can reduce the presence of bubbles. In some variations, the fluid conduit can have an uneven profile, wherein a transparent portion (e.g., an optical sensing region) has a reduced cross-sectional area, which creates a pressure differential configured to expel bubbles from the transparent portion. For example, Fig.77 A cross-sectional view of a fluid conduit (7700) having a transparent portion (7702) having a reduced cross-sectional area relative to other portions of the fluid conduit (7700) is depicted. In the reduced cross-sectional area, the fluid flow rate increases suddenly, which helps to eliminate bubbles adhering to the surface of the fluid conduit (7700) in the transparent portion (7702). Various profiles can be used to increase turbulence in the transparent portion (7702) to facilitate the elimination of bubbles. In some variations, the fluid conduit can be coupled to one or more of a vibrator and a solenoid that are configured to expel bubbles at predetermined intervals.

[0264] In some variations, external optical noise (e.g., from ambient light sources) is reduced and / or compensated by using one or more mechanisms described in detail herein to improve the accuracy of optical signal measurement. For example, during the measurement process, a closure (e.g., an opaque housing, cover, lid, baffle, door) can be used to shield the transparent area of ​​the fluid conduit (e.g., the optical sensing area) from the influence of external light. In some variations, a collimator located in front of the detector can be configured to reduce the detection of external optical noise (e.g., stray light). Additionally or alternatively, the fluid conduit can include one or more light absorbing portions (e.g., opaque portions, rings) at the proximal and / or distal ends of the transparent portion. The light absorbing portion is configured to reduce the conduction of light from a light source external to the patient monitoring device. In some variations, the optical sensor device can be configured to measure the amount of external light so that the optical property measurement and / or calculation can be modified to compensate for the measured external light. For example, the emitter of the optical sensor device can be configured to generate light in a pulsed manner. When the emitter is emitting pulsed light, the optical property can be measured by at least one detector, and when the emitter is not emitting light and is "in the dark", the amount of external light can be measured by at least one detector.

[0265] Fig.43A cross-sectional view of a primary light scattering / absorption system is depicted. A fluid flows through a fluid conduit (15) along with particles (81). A light source (82), a convex-planar lens (83), a light detector (84), and the fluid conduit are assembled in a fixture (85). The light source (82) emits light and the convex-planar lens (83) collimates the light waves. One detector (84) is oriented 180 degrees relative to the emitter (82) and receives the remaining light after the light passes through the conduit (15). Another convex-planar lens (83) is oriented 90 degrees relative to the emitter and receives side scattered light. The convex-planar lens collimates the received light before it reaches the light detector (84) oriented at a 90 degree position.

[0266] Other lens types (equiconvex, biconvex, converging meniscus, positive meniscus) can be used to focus light from the source or scattered light to the detector. The wavelengths of light can be propagated in phase or out of phase. For a wider frequency band of the light source, filters can be used to propagate discrete wavelengths.

[0267] In some variations, a scintillator may be used to improve the signal strength of the light detector (84). In some variations, the light detector (84) may have a larger surface area to capture more light. Fig.43 As shown, the light detector (84) is oriented perpendicular to the radial direction of the fluid conduit (15). Additionally or alternatively, the light detector (84) can be arranged at a certain angle (<90 degrees or >90 degrees) relative to the radial direction of the fluid conduit (15) to effectively increase the surface area in the light path, thereby receiving additional light and / or preventing light from being reflected back into the fluid conduit (15).

[0268] As an alternative or in addition to the light scattering / absorption system described, a spectroscopic system can be integrated to perform broadband wavelength absorbance analysis to determine specific components in the fluid. Fig.44 The forward optical system is depicted. A white light source (82) propagates a broadband wavelength to a monochromator (87). Discrete wavelengths are propagated through a fluid channel (15), components in the fluid (81) absorb different wavelengths in the spectrum, and a detector (84) measures the resulting light. The backward optical system can be similarly integrated.

[0269] When a light scattering / absorption sensor is used within a system, the material of the fluid interface surface can include a material with high optical transparency (e.g., one or more of acrylic resins, cyclic olefin copolymers), and a material combined with high thermal conductivity (e.g., Pyrex glass or glass-fiber nylon) or a material with high antifouling properties (e.g., polysiloxane coated with polyethylene glycol (PEG), polysiloxane coated with hydrogel, polyurethane coated with zwitterions (phosphorylcholine, sulfotrimethylammonium betaine), polyvinyl chloride (PVC) coated with polyethylene oxide, and amphiphilic polysiloxanes) to maintain consistent optical transparency during use.

[0270] Materials that are sensitive to bacterial contamination may also be used to amplify changes in light scattering / absorption levels. At the light absorption angle (180 degrees), increased light scattering / absorption associated with infection will generally reduce the light received by the detector. Bacterial contamination of the tube material may also reduce the amount of light received by the detector, thereby amplifying the signal. Alternatively, any biological contamination of the material that results in a reduction in light received by the detector of the light scattering / absorption system may be used to indicate one or more of replacement, cleaning, and maintenance of the fluid channel.

[0271] In complex fluids such as blood, urine, ascites, and peritoneal dialysis drainage, identifying particles that represent specific complications is challenging. Fig.35 As shown, different particle types (erythrocytes, chylomicrons, triglycerides, leukocytes) may have unique, distinguishable light absorption spectra. In some variations, the sensor may be sensitive to a wide range of wavelengths and configured to measure the entire absorption spectrum to identify the unique light absorption spectral characteristics of the particles present, but such a system may be relatively large and expensive in some cases. Measuring within certain selected wavelength ranges (e.g., infrared ranges) may enable the minimum differentiation of different particle types based on their light absorption behavior, making it difficult to distinguish different particle types (e.g., erythrocytes, chylomicrons, triglycerides, leukocytes) when measuring optical properties within the infrared range. Therefore, in some variations, optical measurements of a fluid within a specific wavelength range or frequency band may indicate the presence of any one or more of a plurality of particle types in the fluid, which may result in the inability to determine which particle type(s) are present in the fluid based on a given sensor signal. For example, an optical measurement result for a wavelength range may correspond to a cell concentration of erythrocytes or leukocytes or a combination of both.

[0272] In some variations, measurements can be made by at least one sensor at a set of different (e.g., discrete) wavelengths or wavelength ranges to distinguish particles present in the fluid and their characteristics. Multi-level light scattering / absorption measurements can be used. For example, based on the difference in absorption spectra between particle types, a first-level light scattering / absorption measurement can use a first wavelength range (e.g., an infrared wavelength range) to detect an overall increase in particle concentration in the fluid (the first wavelength or wavelength range can be a "non-specific" wavelength or wavelength range). In addition, a second-level light scattering / absorption measurement can be used to distinguish particle types, and the second-level light scattering / absorption measurement uses a second wavelength range (e.g., in the near-ultraviolet spectrum) that is different from the first-level measurement (the second wavelength or wavelength range can be a "specific" wavelength or wavelength range). Additional levels of various wavelength ranges can also be used to distinguish other specific particle types. For each level of light scattering / absorption measurement, one or more light emitters and one or more detectors can be used to measure the scattering or absorption of light. Additional detectors can be used to measure data from another scattering angle and can be used, for example, to improve signal strength. This group of detectors can also be used to verify the data generated from the main sensor to eliminate any erroneous data points. For example, photodetectors at about 90 degrees and about 180 degrees relative to a single emitter may be expected to have similar ratios. However, if the ratio deviates from a predetermined threshold, the deviation may be erroneous and may be filtered out. In some variations, both the emitter and detector may have narrow or broad wavelength emission / detection bands, with or without filters.

[0273] In some variations, sensor data from multiple stages may be analyzed to identify a particle type based at least in part on one or more correlation graphs of possible particle types. In some variations, a correlation graph may be generated empirically or theoretically for each measurement stage based on the concentration of each particle type. For example, Fig.36 A graph of an exemplary sensed output voltage versus leukocyte concentration for a light scatter / absorption sensor is shown. Fig.36For example, based on empirical data, the relationship between one or more sensors under controlled conditions and the changing white blood cell concentration in the measured fluid is shown. The relationship between the white blood cell concentration and the sensor signal can be characterized and / or accessed by a parametric equation, a lookup table, etc. As another example, another graph of the sensed output voltage versus the red blood cell concentration (or other suitable fluid characteristics) can be similarly generated, and a unique curve (e.g., having a corresponding relationship that can be characterized and / or accessed, for example, by a parametric equation, a lookup table, etc.) is displayed. Therefore, using the corresponding curves or correlation diagrams of white blood cells and red blood cells, the measured sensor signal (e.g., voltage) can be associated with the white blood cell concentration and / or the red blood cell concentration (or other fluid characteristics) in the measured fluid. Depending on the selected band and the absorbance of the particle type within the band, the correlation diagram may be unique for different particles. For example, for an optical sensor that does not distinguish between particles (e.g., the 850nm-870nm band), the concentration diagrams of red blood cells and white blood cells may be substantially the same. In contrast, for an optical sensor that distinguishes between particles (e.g., the 400nm-420nm band), the concentration diagrams of red blood cells and white blood cells may be significantly different.

[0274] Additionally or alternatively, based on correlation plots such as those described above, one or more ratios of sensor data associated with different levels (e.g., measurements in different wavelength bands) may be calculated and plotted against particle type concentration to yield additional correlation plots. Fig.37 is a correlation plot of sensor data measured from the first and second level sensor systems (e.g., voltage from the first level sensor system relative to (e.g., divided by) voltage from the second level sensor system) for different white blood cell concentrations. For red blood cells, a similar correlation plot can be created using sensor data measured from the first and second level sensor systems. Because WBC and RBC particle types have unique absorption characteristics within the second level band, this ratio may be different for each particle type.

[0275] Correlogram data generated at different levels (e.g., discrete wavelength ranges or bands) can allow for differentiation (e.g., identification) of particle types in a fluid. This can be useful when an optical measurement of a fluid within a particular wavelength range or band may indicate the presence of any one or more of a variety of particle types in the fluid, which may lead to ambiguity as to which particle type is present based on a given sensor signal. For example, an optical measurement for a wavelength range may correspond to a cell concentration of red blood cells, white blood cells, or a combination of both. Additionally, one particle type in a fluid may be more dominant (e.g., have a higher concentration) than other particle types.

[0276] Typically, an optical sensor can be configured to measure a fluid in two or more wavelength ranges. For different particle types, the measurements in different wavelength ranges can be plotted for known concentration relationships. A set of possible particle type concentrations can be estimated from these plots. The estimated concentrations can then be compared to each other to find substantially matching values. When the estimated concentration values ​​for a particle type match between the different plots, the particle type can be estimated. For example, the concentration of an unknown major particle type can be identified in a set of one or more known (or predetermined) correlation plots (e.g., concentration curves). The set of correlation plots can, for example, include correlation plots for a particular particle (e.g., conceptually similar to Fig.36 ) and one or more ratio-based correlation diagrams (e.g., similar to the correlation diagram shown in FIG. 1 , which relates (i) a signal at one wavelength to (ii) a specific particle type such as a leukocyte) and one or more ratio-based correlation diagrams (e.g., conceptually similar to Fig.37 , which correlates (i) ratios of signal data for multiple wavelengths to (ii) specific particle types, such as white blood cells). In general, using this set of correlation plots in a multi-stage process, sensor signals and ratios of sensor signals for measurements at different wavelengths can be correlated to specific particle types, as shown in the example below.

[0277] Example 1: A first stage (e.g., particle-insensitive) optical sensor may be configured to measure fluid between a wavelength band of about 850 nm to about 870 nm, and a second stage (e.g., particle-sensitive) optical sensor may be configured to measure fluid between a wavelength band of about 400 nm to about 420 nm. The sensor output voltage measured by the first stage optical sensor is 0.95 V. The output voltage measured by the second stage optical sensor is about 0.15 V.

[0278] Fig.38A and Fig.38B Depicted is the application of a correlogram to identify particle type and concentration from the two signals output from the primary and secondary optical sensors. Fig.38A is a superposition of a predetermined correlation graph of a sensor signal (e.g., an optical measurement at a wavelength within a first wavelength range or band (e.g., infrared)) and a predetermined correlation graph of a sensor signal and a red blood cell concentration (the curves are substantially the same for white blood cell and red blood cell concentrations). Specifically, the sensor signal is from a first optical sensor configured to measure fluid between about 850 nm and about 870 nm. In this example, the first optical sensor provides a signal output of about 0.95 V, which indicates that (based on the Fig.38A In the example above, the fluid being measured has an unknown concentration of particle type (leukocytes or red cells) at a concentration of approximately 23 cells / μL. To help determine whether the fluid concentration is 23 white cells / μL or 23 red cells / μL, a flow cytometer such as Fig.38B One or more of the ratio-based correlation plots shown are subjected to a second step of analysis.

[0279] Fig.38B is an overlay of ratio-based correlation plots of white blood cells (WBC) and red blood cells (RBC). Specifically, Fig.38B The WBC and RBC curves in correspond to a known concentration relationship of the ratio of the sensor output measured in a first wavelength range ("wavelength A") divided by the sensor output measured in a second wavelength range ("wavelength B") (measurements of the first stage relative to measurements of the second stage). In this example, the ratio of the first stage to the second stage (λA / λB) is calculated to be 0.95 / 0.15=6.33. The measured ratio of 6.33 intersects the WBC curve at 23 cells / μL and does not intersect the RBC curve at all. Therefore, Fig.38B The ratio-based correlation plots indicate that the measured cell concentration of 23 cells / μL is the concentration of white blood cells. In other words, since the estimated WBC concentration values ​​match on the different correlation plots, the light scattering / absorption measured by the first and second optical sensors is largely due to WBC particles and to a minimal extent due to RBC particles. Therefore, the measured WBC concentration values ​​can be used to determine patient infection, as described in more detail herein.

[0280] Example 2: In this example, the two stages of light scattering / absorption can be performed at wavelengths with different absorption characteristics for different particle types. The first stage (e.g., particle-insensitive) optical sensor can be configured to measure the fluid at a wavelength of about 260 nm (wavelength C), and the second stage (e.g., particle-discriminating) optical sensor can be configured to measure the fluid at another cell-specific wavelength (wavelength D). The sensor output voltage measured by the first stage optical sensor is about 0.950 V. The output voltage measured by the second stage optical sensor is about 0.194 V.

[0281] Similar to Example 1, you can use Fig.39A and 39B The first and second level sensor data are analyzed by the correlation diagrams for different particle types shown. Specifically, Fig.39A The sensor signal output measured at wavelength C for WBC and the sensor signal output measured at wavelength C for RBC are superimposed. In this example, the first stage optical sensor provides a signal output of approximately 0.950 V, which (based on the Fig.38A The value is related to the cell concentration in the PCR results (which showed that the WBC concentration of the measured fluid was about 44 cells / μL or the RBC concentration was about 23 cells / μL. Fig.39AIt is not clear whether the first order sensor signal should be correlated with this WBC concentration or this RBC concentration. Therefore, one or more ratio-based correlation diagrams (e.g. Fig.39B The second step of analysis was performed using the correlation diagram shown in Figure 2.

[0282] and Fig.38B similar, Fig.39B is an overlay of ratio-based correlation plots of white blood cells (WBC) and red blood cells (RBC). Specifically, Fig.39B The WBC and RBC curves in correspond to a known concentration relationship (first order measurement relative to second order measurement) of the ratio of the sensor output measured in a first wavelength range ("wavelength C") divided by the sensor output measured in a second wavelength range ("wavelength D"). In this example, the Wavelength C / Wavelength D ratio is calculated as 0.950V / 0.194V=4.9. This measured ratio of 4.9 is plotted on the known WBC ratio curve and RBC ratio curve. The ratio of 4.9 intersects the WBC curve at 44 cells / μL, but intersects the RBC curve at 44 cells / μL. Fig.39B The RBC curves shown do not intersect. Fig.39A and 39B Both indicate an estimated WBC concentration of 44 cells / μL, so the measured cell concentration can be determined to be primarily related to WBC (concentration of approximately 44 cells / μL).

[0283] In another method of distinguishing particle types, it is possible to distinguish between unevenly and evenly mixed particles. The light scattering / absorption sensor can be sampled at a high enough frequency (e.g., 50 Hz) to detect particles as they flow through the sensor. Fig.40A As shown, a homogeneous fluid will show lower variation in each measurement.

[0284] In the case of multiple discrete particles passing through, the light scattering / absorption sensor will obtain a spike in the measurement output as the particles pass through, and may obtain a correspondingly high data variation, such as Fig.41A shown.

[0285] The sensors described herein can also detect single strands (e.g., fibrin stringers). Fig.42B ) When passing through the light scattering / absorption sensor, the measured light scattering / absorption value will change greatly, such as Fig.42A As shown, after this, the signal should return to the measurement result corresponding to the body fluid light scattering / absorption. In some variations, the strip and non-uniform particles can be excluded in the subsequent data analysis. The light emitter can be a light emitting diode (LED) source or a laser. The light emitter can include additional optical devices such as convex-planar lenses to collimate the light source. The light source can also integrate a filter to narrow the wavelength band.

[0286] Integration of light scattering / absorbing light emitters and detectors in a housing should include light shielding via opaque enclosures around the light scattering / absorbing sensor emitters and detectors to exclude ambient light noise and optimize light scattering / absorbing sensor performance.

[0287] The output voltage value of the light scattering / absorption sensor can be converted into formalin turbidity units (FTU) for direct use or as a difference. Before the freshly infused dialysate solution enters the human body, its light scattering / absorption can be measured by a sensor and compared with the light scattering / absorption of the drainage dialysate solution leaving the human body to determine the difference or ratio of light scattering / absorption. For example, the light scattering / absorption level of the drainage dialysate can be monitored separately (usually in the range of 5-100FTU), or the unitless ratio of the light scattering / absorption of the drainage dialysate to the light scattering / absorption of the infused dialysate can be calculated. Alternatively, since light scattering / absorption is usually associated with an increased white blood cell concentration in an infection event, the light scattering / absorption value can be converted into a specific white blood cell count. In addition to monitoring the onset of infection, the light scattering / absorption measurement of the dialysate can also provide feedback on the patient's response to treatment. For example, when an infection is detected, antibiotic treatment is usually prescribed to the patient. Successful antibiotic treatment should gradually reduce the infection and the concentration of white blood cells present in the drainage fluid. Differences in light scattering / absorption of the dialysate can be monitored throughout treatment as a method of assessing the effectiveness of antibiotic therapy.

[0288] Light scattering / absorption measurements can also be used in conjunction with other data inputs. In one example, a light scattering / absorption system is used in conjunction with a flow sensor. The flow sensor determines the total volume of fluid drained. In the case of peritoneal dialysis, the flow sensor can also determine the dialysis dwell time. Particle concentration can vary based on the amount of fluid drained and / or the dwell cycle time. Therefore, it is important to normalize the light scattering / absorption measurements with the amount of fluid drained and / or the dwell cycle time.

[0289] Due to the onset of acidosis in patients, the pH value of the fluid leaving the catheter may change, which is a patient symptom related to infection. In one use case, the pH sensor can monitor acidosis in peritoneal dialysis patients. A variety of dialysate solutions for peritoneal dialysis have a neutral pH value of 7.0. A known reaction of the human body to infection (such as peritonitis) is acidosis, and its pH value is less than 7.0. The system can use a pH sensor as a method for detecting infection. The pH sensor measures the acidity or alkalinity of the solution by measuring the potential difference. Exemplary pH sensors that can be used include but are not limited to the EVAL-CN0326-PMDZ-ND (Norwood, Massachusetts) of Analog Devices and the PH-BTA (Beaverton, Oregon) of Vernier Software and Technology. The pH sensor connected to the dialysate flow conduit by fluid will monitor the dialysate pH value of fresh dialysate and draining dialysate. Calibration of the pH sensor can be achieved using fresh infusion dialysate of known pH value. The sensor analog output value can be converted directly to a pH value, or the relative difference between the pH sensor output of the fresh dialysate and the drain dialysate can be used. For example, a measurement of the drain dialysate produces an output of 3.2V from the pH sensor, which based on the linear calibration curve may correspond to a pH of 6.5, which may trigger an alarm due to the acidity of the drain dialysate solution. Alternatively, the infused dialysate produces an output of 3.5V, while the drain dialysate produces an output of 3.0V. Based on the sensor design where the output voltage is directly related to the pH value, it can be concluded that the drain dialysate is more acidic than the infused dialysate and an alarm will be triggered.

[0290] For peritoneal dialysis patients, ascitic fluid lactate levels exceeding 25 mg / dL can indicate active peritonitis. Lactate monitoring using an amperometric sensor, such as the Zimmer and Peacock model A-AD-GG-106-L (Royston, England), provides another method for early diagnosis of peritonitis. The lactate sensor functions by generating an electric current when an electrical potential is applied between three electrodes. Analysis of the electrical potential and the generated current determines whether lactate is present in the ascitic fluid. In this system, the electrodes of the lactate sensor can be immersed in or in direct fluid communication with a section of the dialysate flow conduit, such as Fig.45 and 46 Configuration shown.

[0291] The presence of high concentrations of leukocytes in the fluid leaving the catheter can indicate infection. Generally, higher concentrations of leukocytes may be associated with a higher degree of infection. A portion of these leukocytes diffuses into the dialysate, and a concentration exceeding about 100 cells / ml indicates peritonitis. Fresh dialysate solution is a glucose solution with a small amount of substrate, and there are no cells before entering the human body. Peritonitis patients will accumulate leukocytes in the peritoneum to resist infection, and the drainage dialysate solution from the human body will have a certain number of these leukocytes. Therefore, peritonitis can be detected with a cell counter sensor that can distinguish one or more types of leukocytes. Commercially available cell counters include the PHCC40050 (Burlington, Massachusetts) of Millipore Sigma. The method of combining flow sensing and cell counting can generate data in diagnosing peritonitis and other infections. In this system, a leukocyte counting microsensor can be fluidically connected to the fluid flow conduit of the drainage dialysate so that the sensing surface area is continuously in contact with the drainage dialysate solution. The cell counting sensor contains a microfabricated cell sensing area that enables differentiation by cell size and cell volume to determine cell type. White blood cells can be counted by the sensor. In combination, the flow sensor can provide data about the fluid volume measured by the cell counter to normalize the cell concentration per unit fluid volume.

[0292] In another method, cells can be counted by optical imaging and image data analysis to determine the number of white blood cells and / or other cells. A miniature camera (e.g., the commercially available Lumenier CP-520Pico-520TVL Nano Camera 1460 (Sarasota, Florida)) can be aimed at the optically transparent length of the dialysate flow conduit and capture high-magnification, high-resolution images. In this system, the camera can be combined with an optical zoom lens near the transparent length of the dialysate conduit, the camera includes a light source, and shields the camera section from external light that would affect the image taken. The image will be sent to a database server system and analyzed by a microprocessor. The size of white blood cells is different from other cell types and can be distinguished by image analysis with a microprocessor to calculate the total number in any provided image.

[0293] Additionally, surrogates known to be associated with leukocytes can be used to determine the presence or increased activity of leukocytes due to infection. One example is leukocyte esterase, which can be determined using test strips such as the Siemens Multistix 10SG. This test is based on the esterase activity of polymorphonuclear leukocytes. High esterase activity suggests infection through high activity or high concentrations of polymorphonuclear leukocytes. Another surrogate-based test to determine the onset of infection includes chemiluminescence that utilizes phagocytosis. Chemiluminescence links a luminescent signal to the phagocytic activity of the cells, which indicates a high concentration or phagocytic activity of certain types of leukocytes. Therefore, a high chemiluminescent signal can indicate increased activity or concentration of certain leukocytes.

[0294] Patients with infection may develop a rash near the catheter exit site, which will cause redness and other discoloration of the skin. A miniature camera can also be set up and aimed at the skin area near the catheter exit site to monitor the rash. In another method, an RGB color sensor such as the Texas Advanced Optoelectronic Solutions model TCS3472 (Plano, Texas) can be used to aim at the skin area near the catheter exit site to monitor the rash. In either method described, the shading results around the measurement location can be used in conjunction with the light source to optimize the accuracy of the sensor.

[0295] Pressure Sensing

[0296] Pressure sensing of indwelling catheters as fluid is injected into or leaves the catheter can provide useful information about potential catheter misalignment, leaks, or blockages while administering treatment. For example, pressure measurement during the infusion of a solution through a pump system can detect a sudden drop in pressure indicating a leak or a sudden rise in pressure indicating a blockage in a fluid catheter.

[0297] Catheter pressure sensing can also provide useful insights into monitoring a patient’s vital systems when treatment is not being administered. For example, with a central venous catheter, a catheter is placed in a patient’s vein with the tip near the right atrium of the heart. When the system is connected to a central venous catheter, pressure measurements can provide important patient information, including central venous pressure, heart rate, and respiratory rate.

[0298] Pressure sensors have a variety of operating mechanisms, including but not limited to piezoresistive, capacitive, electromagnetic, optical, resonant, thermal, ionization, and potentiometric. Commercially available pressure sensors include the Omega PX26-005GV fluid pressure sensor (Norwalk, Connecticut).

[0299] Fig.45The use of a pressure sensor is depicted. Voltage (76) is provided by the microcontroller and grounded, and the sensing surface of the sensor (75) is fluidly connected to the fluid conduit (15). The signal output from the sensor (80) is measured by the microcontroller.

[0300] In this system, if Figures 16A-16C As in the configuration described, the pressure sensor can be fluidly connected to the catheter via the patient monitoring device, wherein the pressure sensor can be placed as a sensor (44) in the fluid catheter. During the infusion and / or drainage cycle of the dialysate solution, pressure changes may indicate potential complications. For example, increased pressure during infusion or drainage indicates potential catheter blockage. During infusion, if the pressure suddenly drops, the system may detect a catheter or connector leak, or a patient abdominal hernia.

[0301] In the case of peritoneal dialysis patients, where a catheter is implanted in the peritoneal cavity, the system can monitor intraperitoneal pressure. There is a correlation between intraperitoneal pressure (IPP) and some known complications associated with peritoneal dialysis, including pleural effusion, abdominal wall hernia, and gastroesophageal reflux. In addition, pressure changes during the dialysate infusion cycle may indicate an indwelling catheter obstruction, dislocation, or leakage. Pressure sensors can be used to detect these complications.

[0302] During the dwell cycle, or after the dialysis cycle is complete, the dialysate tubing can be disconnected, in which case the sensor system is in Fig.13 In the described configuration, the sensor system remains attached to the indwelling dialysis tube. During the dialysate retention phase, if the pressure drops suddenly, the system may detect a leak in the catheter or connector or a patient's abdominal hernia. Between dialysis cycles, when there is no dialysate solution in the patient's body and the hardware sensor system is connected to the indwelling dialysis catheter, the measured pressure is directly related to the intraperitoneal pressure (IPP), which can be used for patient life system monitoring. IPP may be related to the respiratory cycle, blood pressure, and cardiac output. In one use case, the signal processing performed by the microprocessor or database server central processor in the patient monitoring device can separate the respiratory waveform from the pressure data. Since poor dialysis results in shortness of breath, IPP can display changes in the respiratory waveform, thereby triggering an alarm for potential reduced ultrafiltration effects. The respiratory cycle can therefore be used as another patient monitoring method.

[0303] Patient motion sensor

[0304] The patient's body movement and position are important indicators of the patient's health. The patient's overall health status can be used alone or in combination with other patient monitoring data. Accelerometers and / or gyroscopes with one or more axes can measure the patient's movement and position through the forces generated by the sensor's internal mass / mass, which is displaced by gravity during linear or rotational acceleration. Various accelerometers, such as NXP p / n MMA8453QT (Eindhoven, the Netherlands) and gyroscopes, such as InvenSense ITG-3200 (San Jose, California) can be used. In this system, the accelerometer and / or gyroscope can be embedded anywhere in the patient monitoring device by fixing the patient monitoring device to the patient's form factor. When the patient monitoring device is fixed to the patient, the patient's position and movement will be directly converted into measurements of the accelerometer and / or gyroscope.

[0305] Gyroscope data can be used to monitor patient position. Gyroscope data can be used to quantify the duration of time a patient is lying down. The total daily time a patient is not lying down can be monitored as an indicator of patient activity. Any significant deviation in duration can trigger an alarm.

[0306] In another use case, the combination of a gyroscope and an accelerometer can be used to detect a patient fall event. A patient fall related or unrelated to dialysis treatment may trigger an alarm.

[0307] Flow Differential Sensor

[0308] A flow sensor can track the flow rate and direction of a fluid or gas along a channel. In this system, the flow sensor can be fluidly connected to a conduit, where the cross-sectional area of ​​the conduit is constant over the length containing the flow sensor. The rate of infusion and exit of the fluid can be tracked by a flow meter. Given a fixed channel cross-sectional area, volume data can also be derived.

[0309] In the case of the use of flow sensors for peritoneal dialysis patient monitoring, the flow meter will operate throughout the infusion and drainage cycle. The total flow of the infusion and drainage solution can be quantified. The dialysate infusion volume (Vi) and the waste dialysate drainage volume (Vw) can be used to determine the Vw / Vi ratio. The Vw / Vi ratio mainly represents the permeability of the peritoneal membrane to water, but also represents other dialyzed solutes from ultrafiltration. The Vw / Vi ratio usually remains stable during the first 6 weeks of a patient's peritoneal dialysis treatment. Therefore, the Vw / Vi ratio can be used as an indicator to determine the effectiveness of dialysis.

[0310] Flow sensors can also be used to monitor patient compliance assurance. When the fluid is connected to the catheter, the flow sensor can use the flow directionality data to determine whether it is an infusion flow or a drainage flow. In the system, the flow meter can be connected to the time data. When the flow sensor detects a non-zero flow rate and the flow direction is along the infusion direction, the microprocessor can record the infusion start time. When the flow sensor detects a zero flow rate after the initial infusion, the microprocessor can record the retention start time. When the flow sensor detects a non-zero flow rate and the flow direction is along the drainage direction, the microprocessor can record the drainage start time. In this way, for each cycle of each treatment method, the infusion, retention and drainage times can be recorded to determine the patient's compliance with their prescribed therapy.

[0311] Flow sensors can also be used to detect catheter blockage. When the system is used for peritoneal dialysis, for some steps of the CAPD or even CCPD cycle, fluid flow is infused or drained by hydrostatic pressure difference. During dialysate infusion, the bracket keeps the dialysate at a height above the patient, which produces a relatively constant positive pressure gradient, and the dialysate flows into the patient. During dialysate drainage, the drainage tube is positioned at a height below the patient close to or on the floor, which produces a relatively negative pressure gradient, and the dialysate flows out of the patient. Because the pressure gradient during each cycle is quite consistent (depending on the position of the patient), the average fluid flow rate of each cycle should be quite consistent. However, a slowing of the fluid flow rate between cycles will indicate a blockage somewhere in the fluid flow line. An increase in fluid flow rate will indicate a potential system leak. In order to determine either condition, the average flow rate of each cycle can be measured and recorded, or the total duration of each cycle can be simply measured and recorded.

[0312] There are a variety of flow sensor mechanisms, including but not limited to mechanical flow meters, pressure-based flow meters, Doppler flow meters, optical flow meters, slotted flow meters, ultrasonic flow meters, and electromagnetic flow meters. For example, a compact ultrasonic flow meter, such as the Parker CFM1 flow meter (Parker Hannifin; Cleveland, Ohio) can be used. In another example, the flow sensor is a microfluidic chip with a microsensor. The sensor is capable of measuring the flow of liquid inside a cost-effective planar glass substrate. The digital microsensor chip provides all signal processing functions to achieve a fully calibrated, temperature compensated, and linearized digital output. In addition, the sensor also provides real-time detection of faults such as blockages, bubbles, or leaks. This can provide data on catheter leaks, line blockages, and even possible diagnosis of hernias in patients.

[0313] Solute measurement sensor

[0314] In the case of dialysis patients, analyte measurements of the solution indicate the effectiveness of the dialysis treatment. For example, salt, urea, and creatinine are key solutes that diffuse into the dialysate during peritoneal dialysis treatment. In order to monitor the effectiveness of the treatment, these analytes can be measured. In one approach, the salt content can be measured with an ion conductivity sensor. Fig.46 A mechanism for conductivity measurement is depicted. A square wave voltage input (88) is generated by a microcontroller and transmitted to a transmission electrode (89). The transmitted current is conducted through the dialysis catheter (15) by the fluid medium and is conducted to a second electrode (90). In this system, both conductivity electrodes are immersed in a section of the dialysate line and a constant separation distance is maintained between the electrodes to measure the conductivity of the dialysate solution. Additionally or alternatively, the patient monitoring device may include a non-fluid contacting annular conductivity sensor. The amplitude of the received voltage (91) is measured by the microcontroller and varies depending on the conductivity and presence or absence of the fluid in the fluid conduit. Since the salt content in the fluid affects the conductivity, the salinity of the dialysate can be measured by the conductivity mechanism described. The conductivity of the infusion and drainage dialysate solutions can be measured. Glucose concentration is inversely proportional to ionic conductivity and can monitor the adequacy of ultrafiltration when analyzed together with salt concentration as part of the overall fluid ionic conductivity measurement. The value of the drain dialysate solution conductivity can be monitored alone, or the relative difference between the infusion and drain dialysate solution conductivities can be monitored. Conductivity measurements vary with temperature, therefore, this measurement is combined with a temperature measurement and normalized to a reference temperature, typically 25 degrees Celsius. Ionic conductivity measurements can be used alone or in conjunction with fluid flow differentials (via flow sensors) to characterize analyte and fluid extraction from the ultrafiltration process.

[0315] Urea is a colorless crystalline compound that is the main nitrogen-containing decomposition product of mammalian protein metabolism and is excreted in urine. Since the kidneys help humans break down key toxins and nutrients in the body, patients with acute to chronic renal failure require dialysis. The success of dialysis treatment can be quantified by tracking urine clearance. The urea concentration in the patient should decrease, while the urea concentration in the dialysate should increase. Common techniques for measuring small solute clearance include urea clearance normalized with whole body water. Urea sensors measure the concentration of urea in fluid samples. Using electrochemical sensors, urea levels can be tracked with high specificity and resolution. Urea sensors are usually constructed by connecting a hydrophilic polymer membrane containing immobilized urease to a commercially available ammonia electrode, which in turn includes a pH glass electrode covered by an internal electrolyte and a gas-permeable hydrophobic membrane. Allowing the sensor to sense urea that should not be present in the inlet dialysate solution and compare it with the drainage dialysate solution leaving the peritoneum produces a powerful indicator for determining the effectiveness of dialysis. To best utilize this sensor, high specificity would require slowing down a small volume of dialysate solution through an indwelling catheter to obtain an optimal sensor reading of urea concentration. In this system, the urea sensor measurement surface would be fluidly connected to both the infusion dialysate solution and the drain dialysate solution.

[0316] Another technique for evaluating the effect of dialysis is peritoneal creatinine clearance (CCr). Creatinine clearance is used to evaluate the overall small solute clearance during dialysis. Enzyme-catalyzed polymer conversion with electrochemical impedance spectroscopy is used to determine creatinine in serum samples. Similar to the design of the urea sensor, urease is replaced by creatinine deiminase. Poly(methyl vinyl ether) / maleic anhydride is screen-printed onto a cross-digital screen-printed carbon electrode, and the electrode is covered on an absorbent pad containing the relevant enzyme. The presence of creatinine in the serum sample will result in rapid polymer conversion, which will result in a change in the capacitance of the electrode coated with the polymer, which depends on the analyte concentration. As a result, a creatinine sensor is produced. The same system can be used for urea or other serum detection. The sensor depends on the pH change of the catalytic reaction, so it can be used to measure pH values ​​and can also be used for infection detection. In this system, the creatinine sensor measurement surface connects the fluid to the infusion dialysate solution and the drainage dialysate solution.

[0317] The dialysis effect can also be monitored by the glucose concentration in the dialysate solution. The glucose in the dialysate solution is equivalent to the right-handed body, D-glucose (D-isomer, D-glucose). Common dialysate concentrations of glucose include 1.5%, 2.5% and 4.5% levels. During the PD cycle, the permeability of the peritoneum allows some glucose to diffuse into the patient's body. Therefore, the measurement of glucose concentration can be related to peritoneal permeability, which also represents the permeability of other solutes. In this system, the glucose sensor measurement surface will be retained in the fluid conduit connected to both the infusion dialysate solution and the drainage dialysate solution. The fluid conduit will also include a flow sensor. The combined flow rate data, fluid conduit cross-sectional area and glucose concentration measurement will allow the calculation of glucose concentration / dialysate volume. Since the concentrations of glucose and salt can affect the ionic conductivity of the fluid, a glucose monitor and an ionic conductivity sensor can be used in combination to calculate both the concentrations of glucose and salt.

[0318] In addition to monitoring the permeability of the peritoneal membrane to solutes, glucose measurement can also help prevent hyperglycemia or hypoglycemia during dialysis treatment. During dialysis, a portion of glucose is also absorbed into the peritoneal tissue, and a large number of dialysis patients also suffer from diabetes. Therefore, it is desirable to monitor the reduction of glucose content in the dialysate post-treatment.

[0319] There are many glucose monitoring technologies commonly used in diabetes management. An exemplary glucose measurement sensor that can be used includes the Zimmer & Peacock ZP Glucose sensor (Napa, California). In another sensor type, the combination of microdialysis and infrared spectroscopy provides a calibration-free assay for accurate and continuous glucose monitoring because the reference spectrum of the dialysate composition can be determined by inference. The sensor directly measures glucose concentration by amperometric detection of hydrogen peroxide.

[0320] In another variation, the solute measurement sensor can also be used to determine if the correct dialysate solution is being infused as a method of monitoring patient compliance. Dialysate solutions typically have different glucose concentrations. To monitor dialysate concentration, a glucose sensor can be used.

[0321] Plug-in system

[0322] In some variations, the docking system can be used in conjunction with a patient monitoring device. The docking system (e.g., a docking station) can perform a variety of functions, including cleaning, calibration, charging, data processing, and periodic data transfer. The docking system itself can be plugged into a socket power source (e.g., a wall outlet, power provided by a USB connection, etc.) and / or can have an internal battery that can be charged and used wirelessly. In some variations, the docking system can have a safe interlock structure so that it only has electronic functions when connected to a valid power source (e.g., plugged into a working socket power source, with a fully charged battery, etc.). In one variation, a patient monitoring device is used in conjunction with a docking system to regularly clean, charge, disinfect, and calibrate the device. Fig.47A depicts a docking station (94), Fig.47B A docking station (94) is depicted with a patient monitoring device (4710) mounted thereon. The docking station (94) may, for example, include two fluid port connections (95, 96) that are connected to the inlet and outlet of a fluid conduit of the patient monitoring device, respectively. Electrodes (97) on the docking station (94) may be configured to mate with electrical connections on the patient monitoring device (4710) for charging and / or data transfer. Cleaning and calibration fluids may fill a set of fluid cavities via fluid ports (99).

[0323] Figures 48A-48D Another variation of a docking station (4800) is shown that includes a set of fluid chambers (100, 101, 102) in fluid communication with a set of corresponding fill ports (103, 104, 105). In some variations, a fluid, such as a cleaning fluid, may be stored in one or more of the fluid chambers (100, 101, 102). For example, a first cleaning fluid may be pumped from a first fluid chamber (101) and a second cleaning fluid may be pumped from a second fluid chamber (102) into the docking fluid conduit (98). When a patient monitoring device (such as a Fig.47B ), a first pump (106a) connected to the first fluid chamber (100) can circulate the first fluid out of the first fluid chamber (100) and into the plugged fluid conduit (98). After circulating the first fluid through the patient monitoring device, a second pump (106b) connected to the second fluid chamber (101) can circulate the second fluid out of the second fluid chamber (101) and into the plugged fluid conduit (98). Finally, after circulating the second fluid through the patient monitoring device, a third pump (106c) connected to the third fluid chamber (102) can circulate the third fluid out of the third fluid chamber (102) and into the plugged fluid conduit (98).

[0324] In some variations, the circulating fluid may be pumped through the docking fluid conduit (98), the inlet (95), the patient monitoring device, the outlet (96) and into a separate compartment (e.g., a waste chamber) in the docking station (not shown) to avoid mixing with fresh fluid (e.g., cleaning fluid) stored in the fluid chambers. Additionally or alternatively, the circulating fluid may pass through a set of filters before returning to one or more fluid chambers (100, 101, 102). In some variations, the docking fluid conduit (98) may include one or more valves configured to divert the circulating fluid between any fluid chamber and the waste chamber. In some variations, the fluid stored in the docking station may be a calibration fluid.

[0325] The calibration fluid may include a fluid having predetermined light scattering / absorption, temperature, and conductivity properties. In addition, the calibration fluid may be pumped through the patient monitoring device at a predetermined flow rate. For example, an isotonic fluid such as a phosphate buffer solution may be heated to about 37.0°C in the calibration fluid chamber (102) and then pumped through the patient monitoring device at a constant flow rate of 200 ml / min via a third pump (106c). The phosphate buffer solution is optically transparent and has a known conductivity value of about 13,000 μS / cm. The patient monitoring device may calibrate its sensors based on the known properties of the calibration fluid. Therefore, in this example, when docked to the docking station, the patient monitoring device may calibrate its set of light scattering / absorption, temperature, conductivity, and flow rate sensors. In some variations, after the calibration fluid is pumped through the patient monitoring device, it may be pumped back into a separate compartment (e.g., a waste chamber) to avoid mixing with fresh, unpumped calibration fluid. In another variation, the calibration fluid may be pumped through a filter and mixed with the rest of the calibration fluid in the calibration fluid chamber (102).

[0326] In some variations, the fluid used for cleaning and calibration can be recirculated in a closed loop system. Fig.47A and 47B In the illustrated docking system, the inlet (95) and outlet (96) allow the fluid to be continuously recirculated for a predetermined time. In some variations, the fluid may be input and output from only one of the inlet (95) and outlet (96) in one or more cycles, thereby allowing a predetermined volume of fluid to clean the fluid conduit of the patient monitoring device in a reciprocating manner over a predetermined time. In some of these variations, the fluid may be a recirculating fluid. In some variations, the cleaning cycle may include a predetermined soak time.

[0327] In some variations, the cleaning fluid may include chemicals for removing scaling / fouling sources. For example, one or more of nitric acid and hydrochloric acid may be used as a cleaning fluid for removing proteins. Additionally or alternatively, an alkaline-based cleaning solution (e.g., III) to effectively remove fats and proteins. Subsequent cleaning with alcohol (e.g., ethanol, isopropanol) or acetone can be used to remove oil and water-based contaminants. Deionized water can also effectively remove water-based contaminants. The valve can be configured to allow air to flush and dry the docking station when the fluid cycle is complete.

[0328] In some variations, the docking system may further include a set of sensors configured to monitor fluid flow and confirm cleaning. For example, a set of optical sensors located in the fluid chambers (100, 101, 102) may measure the amount of fluid in each fluid chamber (100, 101, 102) and be used to indicate when the fluid needs to be replaced. The set of sensors of the docking station may also measure one or more of light scattering / absorption, temperature, conductivity, and / or flow rate of the fluid driven by the pump (106a, 106b, 106c).

[0329] For device calibration, a single procedure can calibrate all sensors in a device, or unique procedures can be used to calibrate individual or groups of sensors. Calibration can be performed at the user's option or remotely by a healthcare provider or device manufacturer. Calibration can also be performed automatically based on a set frequency each time the device is docked or when performance testing indicates that calibration is needed. During calibration, the device can be mechanically locked in the docking station until the calibration process is complete. Calibration results can be sent to a healthcare provider or device manufacturer for quality control and device performance monitoring.

[0330] The interface between the device and the docking station may vary and may include a magnetic lock, a lock (e.g., a shaft lock, a frame lock, a bushing lock, a lock back, a Luer lock), a plug, a screw, or a nut to hold the device in the docking station. The release structure may include a push-on fixture on the device, such as a button or a locking mechanism, but may alternatively include a variety of other physical or electronic variations.

[0331] Cleaning fluid pathways can increase component life by reducing or eliminating the presence of biofilm and other scaling / fouling mechanisms. Similarly, cleaning can be used to remove residual fluid from collected samples. The properties of the fluid pathway material can determine the cleaning mechanism of the docking station. For example, abrasive and / or solvent cleaning can be performed using materials with high hardness and solvent resistance such as quartz, borosilicate, or sapphire glass. Other materials with high lubricity and solvent resistance such as fluoropolymers (FEP, PTFE) can be used for cleaning by flushing with solvents and / or slight abrasion. Alternatively, or in combination with other cleaning agents, ultraviolet light can be used to disinfect the fluid pathways of the device.

[0332] In some variations, a docking station can be coupled to a patient monitoring device without being docked into the docking station. For example, an inlet of a docking station can be flexibly extended to connect to a patient monitoring device without removing or disassembling the patient monitoring device from its own connector (e.g., hooked to a toilet seat). Fig.48B A docking station (94) is shown including a flexible tube (108) configured to transmit fluid and electrical current. Fig.48C A detailed perspective view of the end of the flexible tube (108) is shown. The end of the flexible tube (108) may include a set of electrical connections (109a, 109b) (eg, electrical contacts) and a fluid lumen (110). Fig.48C A detailed side view of a tubing set connector (407) of a patient monitoring device is shown. The tubing set connector (407) may include a set of corresponding electrical connectors (408a, 408b). Fig.48D A perspective view of a flexible tube (108) is shown coupled to a tube set connector (407) such that the electrical connectors are in contact and fluid-tight. The set of electrical connectors may include additional electrical contact points. In some variations, the electrical connectors may be configured for charging and / or communication between the docking station and the patient monitoring device. Fig.48B In the described variation, the fluid pumped from the docking system into the patient monitoring device can leave the patient monitoring device and enter a drainage container such as a toilet. After the fluid cleaning step is completed, a valve in the docking station can be used to allow air to flush and dry the system.

[0333] To charge the patient monitoring device, the patient monitoring device can be placed on the docking station and the exposed electrodes on the docking station mate with the exposed connectors (45) on the patient monitoring device. Alternatively, wireless charging can be used. A charging cycle including a fast charge or a full charge can be implemented. In some variations, the docking station can include a battery charging port configured to charge a battery of the patient monitoring device. For example, a removable battery of the patient monitoring device can be plugged into the battery charging port to charge the battery while another battery is used in the patient monitoring device.

[0334] The docking station can also transfer data from the patient monitoring device. The data transfer can be a single data transfer method for the system, or a redundant data transfer method for transferring data from the patient monitoring device in the event of a communication failure on one or the other system. Thus, the data transfer to the database can be performed by the sensor device and / or the docking station. The sensor device can, for example, transfer data via a wireless cellular LTE module, but sometimes the connection may be limited. Alternatively, the docking station can transfer data wirelessly from a wired Ethernet connection or via a modem, which can be used when the LTE signal of the patient monitoring device is limited.

[0335] The docking sensor may also continuously store sensor data for each patient. Additionally or alternatively, the data may be stored in the cloud. For example, the data may be stored locally on an SD card or other storage device, and the patient may bring the SD card to the healthcare provider during frequent visits to the healthcare provider to monitor the data. In some variations, the docking system may authenticate the patient monitoring device connected thereto before performing one or more functions such as cleaning, calibration, data transfer, etc.

[0336] Sample collection

[0337] When certain threshold action limits are detected, the system may also prompt other actions. In one example, a sterile collection container can always be loaded in the device to collect a fluid sample, which can be sent to a laboratory for analysis. When potential complications are detected, the patient's fluid sample can be collected in a container. An example of a mechanism for collecting a sample is to pierce a tube through which a fluid flows by a sterile needle connected to a sample container to collect the sample. The needle can also be oriented in the opposite manner so that the needle pierces the lid of the collection container, thereby allowing the fluid to be collected while the lid is kept on the collection container. Alternatively, a pressure-based valve can apply positive or negative pressure to a fluid channel connected to a main line and a collection container to open the channel until enough sample fluid has been collected. In a variation shown in Figure 54, the channel to the sample collection container (110) remains closed due to the two walls of the channel contacting each other, thereby preventing the sample from flowing into the collection container. The walls can be made of a plastic material such as silicone, to which negative pressure (e.g., suction) can be applied in a vacuole (107) next to the channel, thereby opening the channel to collect fluid (108) until the pressure is stopped. As a final example, there may be a manually or automatically controlled valve that can divert flow to a sample collection container.

[0338] FIG55 shows a method for collecting a fluid sample. When the sensor detects that the fluid (108) has complications and a sample needs to be collected, a valve (109) in the fluid channel can be opened from a closed state in FIG55a to an open state in FIG55b, which allows the fluid to flow into a sample collection container (110). When a sufficient amount of sample is collected, as shown in FIG55c, the valve is closed. When the fluid is collected automatically, the system can determine when the sample collection container is full by weighing the container or using an optical device to determine when the liquid in the container reaches a threshold level.

[0339] The container may always be sealed, as in the case where a needle pierces the lid of the container to collect the sample. Otherwise, the container may be sealed by methods including, but not limited to, a nut that automatically tightens after sample collection, a cap that snaps into a locked position, or a cap that is press-fit onto the container. The container may also be sealed with a tamper-evident seal to ensure the fidelity of the sample prior to further testing and labeled with a patient or sample identifier and a timestamp. The container may also be labeled for shipping and ejected from the device or removed by the patient.

[0340] Therapeutic agents

[0341] In another example, the device stores and administers therapeutic agents. When the limit of motion of a potential complication (e.g., infection or catheter blockage) is detected, the device injects appropriate therapeutic agents (e.g., antibiotics) to treat the infection or thrombolysis to resolve the catheter blockage. Figures 57A-57C An example arrangement of therapeutic agents stored within the device is shown. First, Fig.57A As shown, the therapeutic agent (117) is locked in the device. When the sensor indicates a complication requiring a therapeutic agent, the fluid / body fluid sample is collected in a container for laboratory testing, and a notification (111) is issued when the collection is complete, thereby unlocking the compartment (118) holding the therapeutic agent, as shown. Fig.57B Then, Fig.57C It is shown that the patient can be approached for immediate use of the medication when a corresponding complication is detected.

[0342] Patient infection detection method

[0343] In one variation of the above device, the system can be used to monitor a patient for infection from drainage fluid that exits the catheter during each therapeutic drainage cycle. The patient first assembles the disposable half and the reusable half of the patient monitoring device, flushes the fluid conduits in the patient monitoring device with sterile saline solution, connects the patient monitoring device connector to the conduits, and applies adhesive to the skin. The patient activates the patient monitoring device by turning on the power of the patient monitoring device, then turns on the power of the tablet device, opens the user interface application on the tablet device, verifies LTE connectivity, logs into the user interface application on the tablet device to establish communication with the database server system, and establishes a Bluetooth connection between the user interface application on the tablet device and the patient monitoring device by entering a unique identification code for the patient monitoring device into the user interface. The database server system authenticates the patient login credentials and the patient monitoring device identification code, and sends the authentication certificate and an encryption key for use in the communication request to the user interface system. At power on, the patient monitoring device microprocessor initializes the operating system and firmware and cycles through the readings of each sensor - in-line fluid thermistor, light scattering / absorption sensor, flow sensor, pressure sensor, and pH sensor, skin surface color sensor, and accelerometer / gyroscope position sensor mounted on the PCB. The patient monitoring device confirms the sensor output signal and sends confirmation of the sensor operation to the database server through the user interface system. When the system is initialized, the system enters a calibration mode and notifies the user through the user interface system that the calibration mode is initiated.

[0344] During the calibration mode operation of the drainage infection detection system, the system first determines the baseline readings of the flow sensor, pressure sensor, and skin surface color sensor. The patient monitoring device records the readings from each of these sensors at a sampling rate of 5-100 Hz for a static duration of 30 seconds, which are encrypted, temporarily stored in the patient monitoring device's memory chip, and then transmitted to the database server system through the user interface system. Upon receiving the data, the database server system decrypts the data, sends a communication for successful data transmission, averages the data from each sensor, and uses the average to establish an associated baseline voltage value for each sensor. In the next step of the calibration mode, the user interface system instructs the patient to cough, stand, lie down, walk, sit down, and repeat the cycle. During this period, the accelerometer and gyroscope on the patient monitoring device record data at a sampling rate of 20 Hz, which are encrypted, temporarily stored in the patient monitoring device's memory chip, and then transmitted to the database server system through the user interface system. Upon receiving the data, the database server system decrypts the data, sends a communication for successful data transmission, and performs a correlation analysis between the accelerometer and gyroscope sensor data for each patient position state. The user interface system then instructs the patient to infuse 20 ml of sterile saline solution or other volume of fluid. During this time, the light scattering / absorption sensor and pH sensor of the patient monitoring device record data at 10 Hz or other sampling rate, which is encrypted, temporarily stored in the memory chip of the patient monitoring device, and then transmitted to the database server system through the user interface system. Upon receiving the data, the database server system decrypts the data, sends a communication for successful data transmission, averages the light scattering / absorption and pH sensor data, and uses the average to establish a baseline value associated with the reference solution. The user interface then indicates to the patient that the system setup is complete and the system begins monitoring the patient. After initialization, the system maintains a continuous Bluetooth connection between the user interface system of the patient monitoring device and the tablet device. When the battery of the patient monitoring device or the tablet device needs to be charged, a text message is sent to the patient mobile device and a push notification is sent to the tablet device. When the adhesive and disposable parts of the patient monitoring device are replaced every two months, a text message can also be sent to the patient mobile device and a push notification can be sent to the tablet device during the maintenance cycle. During the annual cycle, the reusable sensor monitor can also be replaced, at which time the entire user initialization and calibration cycle is repeated. Likewise, if the patient monitoring device battery and backup battery are completely drained, the entire initialization and calibration cycle will be repeated after the system is fully charged again.

[0345] During use of the monitoring system, the user may utilize the docking station for charging, cleaning, disinfection, and calibration. At predetermined intervals, such as each day after completing their peritoneal dialysis night cycle, the user (e.g., patient) may connect the patient monitoring device to the docking station. In some variations, the docking station may be placed in a fixed location, plugged into an electrical outlet, and / or operated on battery power. The user may place the patient monitoring device in a cradle of the docking station, such as Fig.47B As shown. In some variations, a user can connect both ends of a fluid conduit of a patient monitoring device to corresponding inlets and outlets on a docking station. When placed, the docking station can detect electrical contact with the patient monitoring device and begin charging the patient monitoring device and cleaning the fluid conduit using the fluid stored in the docking station. In some variations, the patient monitoring device can be recalibrated by the docking station while the cleaning fluid is pumped through the patient monitoring device. For example, a calibration fluid can be pumped through the patient monitoring device.

[0346] The patient monitoring device can also transmit data to the docking station through, for example, electrical contacts. In some variations, the docking system can connect to a home wireless network to transmit data that the patient monitoring device cannot transmit due to, for example, poor LTE wireless communication connectivity. A set of indicator lights arranged on the outer surface of the docking system and / or the device can indicate when the charging, cleaning, disinfection, calibration, and data cycles are complete.

[0347] During the monitoring operation of the drainage infection detection system, when no fluid is drained through the fluid conduit, the flow sensor samples at a frequency of 1 Hz in a continuous working cycle, the gyroscope and accelerometer sample at a frequency of 5 Hz in a continuous working cycle, the pressure sensor samples at a frequency of 20 Hz for 30 seconds every four hours, and the skin surface color sensor samples at a frequency of 5 Hz for 10 seconds every four hours, and the microprocessor operates in a low power mode, and none of the other sensors measures any data. During this low power operation, the data is temporarily stored on the memory chip of the patient monitoring device and is not transmitted. When the system enters the active measurement mode, the data will be fully transmitted.

[0348] During the monitoring operation of the drainage infection detection system, when draining fluid begins, the flow sensor detects fluid flow and the microprocessor activates the system into active measurement mode. The microcontroller controls all sensors to record measurements during active measurement mode at different duty cycles. The flow sensor measures fluid flow at a continuous duty cycle and increases to a sampling rate of 10 Hz. The thermistor measures fluid temperature at a frequency of 5 Hz in a 10-second period at the beginning of drainage and in 2 seconds at the end of drainage (when the fluid flow rate drops to zero). The light scattering / absorption sensor measures fluid light scattering / absorption at a frequency of 5 Hz in 30 seconds at the beginning of drainage and in 10 seconds at the end of drainage (when the fluid flow rate drops to zero). The pH sensor measures fluid pH at a frequency of 5 Hz in 5 seconds at the beginning of drainage and in 30 seconds at the end of drainage (when the fluid flow rate drops to zero). During the active measurement mode, the data is encrypted, temporarily stored on the memory chip of the patient monitoring device at a frequency of once every 5 minutes and at the end of the drainage cycle (when the fluid flow rate drops to zero), and then transmitted to the database server system through the user interface system. When the data is received, the database server system decrypts the data, processes the data, stores the data, and sends a communication for successful data transmission, and then the patient monitoring device deletes the sent data from the memory chip of the patient monitoring device.

[0349] In the variation of the test strip used with the system and device described herein, the action of being started by the patient, automatically or a combination of the two may occur. For example, the test strip can be placed in a default inactive position (e.g., recessed in the test strip cartridge). However, when draining the patient's body fluid, the patient can set the test strip in an active position in the fluid channel (e.g., by pressing a button to advance the test strip from its recessed inactive state to its active state in the fluid channel) to start measuring. In some of these variations, when the test strip is used in combination with other sensors, one or more sensors (e.g., pressure sensors) can monitor one or more characteristics of the fluid in the fluid channel. When the fluid in the channel is identified, the test strip can be automatically advanced from the inactive position (e.g., recessed in the test strip cartridge) to the active position to measure the characteristics of the fluid. When the fluid is identified, a notification can be sent to the patient's mobile device, which can require the patient to confirm that the fluid is flowing through the device before the test strip is pushed into the fluid conduit, thereby limiting the possibility of erroneous measurement when the fluid has not yet reached a stable state or a state that needs to be measured.

[0350] During the monitoring operation of the drainage infection detection system, the patient receives a push notification from the user interface system for additional data entry. At the end of each day, the user interface asks the patient to enter their overall sense of health level 1-5 (5 = very good, 4 = good, 3 = moderate, 2 = uncomfortable, 1 = very poor) and the pain level around the catheter exit site 0-3 (0 = no pain, 2 = mild pain, 3 = moderate pain, 4 = severe pain). After the data is entered, the data will be transmitted to the database server system, which processes the data to monitor the patient infection by calculating the average patient level over time and identifying deviations from the patient average, either when any health level is 1, or when any pain level is 3 or 4.

[0351] During monitoring operation of the drainage infection detection system, pressure data is processed by the database server processor to monitor the patient's vital information (e.g., respiratory rate, heart rate). Accelerometer / gyroscope position sensor data is processed by the database server processor to monitor the patient's activity, determine an indication of the total number of steps the patient walks per day, and the total number of minutes the patient lies down per day. Skin surface color sensor data located near the catheter exit site is processed by the database server processor to monitor the onset of rash by the deviation of the skin redness level from the baseline measurement. Fluid flow sensor data is processed by the database server processor to monitor the patient's fluid drainage volume on a daily or per cycle basis by integrating the flow rate-time graph and multiplying by the fluid conduit cross-sectional area of ​​the fluid flow sensor section. Temperature sensor data is processed by the database server processor to monitor patient fever by calculating the deviation of temperature from a moving average. Fluid light scattering / absorption sensor data is processed by the database server processor to monitor the onset of infection by calculating the deviation of light scattering / absorption from the baseline measurement. Fluid pH sensor data is processed by the database server processor to monitor the onset of infection by calculating the deviation of pH from the baseline measurement.

[0352] During the monitoring operation of the drainage infection detection system, the health care provider enters patient data into the user interface system. The health care provider enters laboratory results from the patient's blood test, urine test, and vital system measurements taken during the clinic visit. The health care provider also enters observation records of the clinic visit, enters yes in the check box after the infection is diagnosed, and attaches the pathogen name and diagnosis date, and enters yes in the check box for other complications, and attaches the complication name and diagnosis date. After the data is entered, the data will be transmitted to the database server system. The laboratory tests, vital test data, and observation records are analyzed and stored. When the infection data or complication data is registered as "yes", the database server system performs a regression analysis on all patient data 4 weeks before the diagnosis date and 1 week after the diagnosis. The database server system also summarizes the occurrence of infection for all patients and the patient data 4 weeks before the diagnosis date and 1 week after the diagnosis. The system regresses the aggregated data as a whole and also performs regression analysis separately for each specific infectious pathogen. The database server system also summarizes the occurrence of complications for all patients and the patient data 4 weeks before the diagnosis date and 1 week after the diagnosis. The system performs regression analysis on the aggregated data as a whole and also on each specific complication separately. This analysis determines if there is a statistically significant correlation between the monitored data and complications or infections, and the database server system uses these results to update the infection and complication detection algorithms.

[0353] During the monitoring operation of the drainage infection detection system, the processed data is presented to the patient and the health care provider on the user interface system. The user logs into the user interface system by transmitting the login credentials or biometric input to the database server system. The database server system authenticates the patient login credentials or biometric input and sends the authentication certificate and the encryption key used in the communication request to the user interface system. The graphical user interface presents the processed data in the form of a data chart over time, the highlighted data points that deviate from the average historical value (i.e., greater than two standard deviations compared to the average), the highlighted data points that deviate from the recognized physiological norms (i.e., in the case of a temperature exceeding 99°F), or the system diagnosis of infection or complications. For health care providers, a summary view of multiple patients is provided, and only those patients are highlighted when specific patients have data that deviates from the average historical value, data that deviates from the recognized physiological norms, or a system diagnosis of infection or complications.

[0354] During the monitoring operation of the drainage infection detection system, the database server system generates an infection alert to the patient and the health care provider directly or through a third-party service in the form of a text message, a push notification and / or an automated phone call. The database server system determines the alert level based on multiple factors. For the patient's sense of health and the pain at the catheter exit site, the database system calculates the moving average and standard deviation, and generates an alert when any single health level drops by two standard deviations compared to the average, when the pain level at any single catheter exit site exceeds two standard deviations compared to the average, or when any health level is 1, or when any pain level is 4. For temperature readings, the database system calculates the moving average and standard deviation, and generates an alert based on any temperature reading that exceeds one standard deviation from the average. For patient activity levels, the database system calculates the moving average and standard deviation, and generates an alert based on a drop of two standard deviations from the average for the number of steps or upright position time for two consecutive days. Patient activity levels and patient vital data based on pressure sensors are also used to calculate daily patient health scores based on a level of 1 or 2. When any patient activity level or patient vital data based on pressure sensors drops by more than one standard deviation compared to the patient average, the patient's health score is set to 1. Otherwise, the patient's score is 2. For fluid light scattering / absorption, pH, and skin surface redness deviation values, the database server system calculates a moving average and standard deviation. When the patient's health score is 1, an alarm is generated when the light scattering / absorption value of any fluid exceeds one standard deviation compared to the mean, or any pH value decreases by one standard deviation compared to the mean, or any skin surface color redness deviation value exceeds one standard deviation compared to the mean. When the patient's health score is 2, an alarm is generated when the light scattering / absorption value of any fluid exceeds two standard deviations compared to the mean, or any pH value decreases by two standard deviations compared to the mean, or any skin surface color redness deviation value exceeds two standard deviations compared to the mean. The system also generates alarms based on diagnoses detected by the system through an algorithm based on outcome regression analysis.

[0355] In another variation, the system monitors infection in a catheter system that infuses only fluids. In this case, the system monitors the patient using a thermistor mounted on the skin surface, a skin surface color sensor, and an accelerometer / gyroscope position sensor mounted on a PCB.

[0356] In another variation of using the device to monitor peritoneal dialysis, the system monitors infection in peritoneal dialysis patients, wherein dialysate is both infused into the patient and drained from the patient. In this case, the system includes the same sensors described above for the drainage catheter, such as an in-line fluid thermistor, a light scattering / absorption sensor, a flow sensor, a pressure sensor, and a pH sensor, a skin surface color sensor, and an accelerometer / gyroscope position sensor mounted on a PCB. However, in addition to measuring the waste dialysate solution during the drainage cycle, the system also measures the light scattering / absorption and pH of the fresh dialysate solution during the infusion cycle, rather than calibrating the light scattering / absorption sensor and the pH sensor. By measuring the light scattering / absorption and pH of the fresh and waste dialysate, the light scattering / absorption difference and the pH difference can be calculated for each cycle. This difference needs to be used in the case where the sensor value drifts over time due to degradation of the sensor mechanism or the optical quality of the interface between the sensor and the fluid medium. Additionally, the system can use flow measurements to monitor patient compliance with prescribed therapy and monitor flow differential, calculated as the ratio of fluid flow drained divided by fluid flow infused per cycle, which can be used to assess the effectiveness of dialysis.

[0357] Sensor Calibration Methods

[0358] Many sensor types require calibration. In particular, optical-based sensors are sensitive to changes in the optical quality of the material between the sensor and the test medium, including the optical sensor enclosure. Therefore, it is important to have a means to frequently calibrate the sensor to obtain optimal accuracy. Fig.13 In the described variation, fresh infusion solution and drain solution pass through the same fluid flow conduit and sensor network, providing the sensor with an opportunity to calibrate with fresh infusion solution each cycle, assuming the fresh infusion solution is optically constant.

[0359] Fig.49 Depicted is a process for calibrating an optical sensor. The flow sensor first provides a reading of the direction of flow to the microprocessor, indicating whether fresh or drain solution is passing through the sensor network. While fresh solution is being infused, the microprocessor enters a calibration mode in which the sensor output is reset to a constant, known value for the infused solution. While draining spent dialysate solution, the microprocessor enters a sensor measurement mode and records the output reading. A similar process can be used to calibrate a pH sensor when the pH of the fresh, infused solution is known.

[0360] In some variations, calibration of the optical sensor may be performed at one or more predetermined intervals, such as when the fluid conduit is replaced, when the fluid conduit is engaged with a durable component, when the device is started, when a clinical event is detected, and the like. For example, the fluid conduit (6830) may be disposable and frequently replaced. Typically, dimensional tolerances of disposable components as well as material differences, surface finish, cleanliness, and other manufacturing differences may vary. Therefore, recalibrating the fluid conduit (6830) at one or more predetermined intervals may improve the accuracy of the optical sensor measurements. In some variations, when the fluid conduit (6830) is engaged to the housing (6802), for example due to replacement of the fluid conduit (6830), a switch may be actuated to signal recalibration. Additionally or alternatively, the fluid conduit (6830) may include an identifier such as an RFID tag or a unique ID chip that is used to identify the fluid conduit (6830) as a replaced disposable component. In some variations, after a new fluid conduit (6830) has been verified and / or certified, the patient monitoring device may perform one or more optical measurements to establish a baseline for optical sensor calibration.

[0361] In some variations, calibration may be performed on a patient monitoring device that is connected only to a fluid drainage catheter. During servicing (i.e., docked in a docking station for charging, cleaning, and calibration), a calibration fluid having a set of predetermined (e.g., known) parameters may be passed through the device, wherein the optical sensor and / or pH sensor and / or conductivity sensor may be calibrated.

[0362] In other variations, calibration can also be performed with the active participation of the patient via a patient user interface. In one example, the accelerometer and gyroscope are calibrated when the hardware sensor system is attached to the patient. The user interface system of the application on the patient's tablet device can then prompt the patient to lie down, sit up, and stand up. As the patient repositions to each state, the sensors are calibrated accordingly.

[0363] It is also possible to use multiple sensor data simultaneously to accurately determine the monitoring indicators. For example, pH and conductivity measurements may be affected by temperature. By using a calibration function that indicates the relationship between conductivity and pH values ​​and temperature, the conductivity sensor and pH sensor values ​​can be converted into accurate outputs of fluid conductivity and pH using temperature input data.

[0364] Sensor measurement method

[0365] Sensors can measure in an absolute or relative manner. In the examples of temperature sensors, pressure sensors, and flow sensors, absolute measurements may be required to accurately determine patient temperature and the volume of fluid infused or drained. Alternatively, where the system measures light scattering / absorption, conductivity, or pH of drained fluid, values ​​relative to fresh infused fluid may be sufficient.

[0366] When measuring in an absolute manner, the accuracy of the sensor may be limited, and the design of such a sensor may result in an overly complex, large, and expensive system. Therefore, it is desirable to have a sensor that can measure in a relative manner. In the variant ( Fig.50 As shown in FIG. 1 ), fresh solution and waste solution pass through the same conduit and sensor network, and the relative difference between the sensor values ​​can be used. A light scattering / absorption sensor (in one example, an infrared emitter that uses light scattering detected by a detector) can compare the light scattering TUi from the fresh dialysate solution with the light scattering TUw of the waste dialysate solution to determine the light scattering / absorption ratio = TUw / TUi. The values ​​of TUw / TUi can then be monitored over time to establish a baseline value and determine baseline deviations that may indicate patient infection.

[0367] In another example, the conductivity of the dialysate solution may be measured by a pair of spaced electrodes, a constant current passed between the electrodes, and the output voltage measured. The difference Vw-Vi between the voltage Vi of the fresh dialysate solution and the voltage Vw of the spent dialysate solution may be measured and monitored over time to establish a baseline value and determine deviations from the baseline that may indicate a patient infection.

[0368] Integrated sensor network

[0369] Sensors can accumulate data alone for the purpose of indicating monitoring, or they can work in conjunction with other sensors. Fig.50 In the example shown, a firmware algorithm on the microcontroller determines the directional information provided from the flow sensor, which is used in conjunction with any other sensors to provide contextual information about whether the test fluid is incoming fresh solution or drain solution. Additionally, the flow rate information from the flow sensor can be used in conjunction with the cell count sensor to normalize the cell count data.

[0370] In another example, sensors can work together to limit power consumption. For example, flow sensors can run continuously to determine if there is any flow in or out of the system. When flow stops, the process can keep some or all other sensors in an off mode or in a powered off or reduced power state. When flow starts, the sensors can be turned on based on the flow status.

[0371] In another example, the sensors can work in conjunction to determine surrogate status. One method of catheter management involves flushing a small amount of heparin or other thrombolytic solution through the catheter between infusion cycles to avoid catheter clogging. An infusion of heparin through the sensor network can be interpreted as an infusion of dialysis solution without a step to detect infusion status. Fig.50 An exemplary process for detecting this condition using a flow sensor and a conductivity sensor is depicted. Heparin has a higher conductivity value, which is generally higher than a fresh infusion solution. When the flow sensor detects that the fluid is being infused, the conductivity can be measured. If the conductivity value is higher than the infused therapeutic solution, the step of detecting the infused replacement solution can be performed, and the measured flow can be excluded or marked as excluded from the flow indicator. When the conductivity value matches the infused therapeutic solution, the microprocessor can begin recording the flow.

[0372] The different sensors may also have some redundancy and correlation. For example, urea content, which may be measured as part of ultrafiltration effect, is correlated to pH, which may be measured as part of infection complication detection. Since a pH sensor may be used to monitor infection, it is important that the system includes redundant sensing mechanisms for ultrafiltration effect and infection detection, and that steps include identifying interactions. For example, in the event that the patient's ultrafiltration effect changes, the urea sensor will include a higher level of detected urea. During this time, the pH sensor will show a decrease in pH level even if the patient does not have an infection. Therefore, during this period, the firmware algorithm can exclude pH data for infection monitoring. In another example, in the event of a catheter obstruction, flow rate and pressure will have a high correlation.

[0373] Sensor hardware can also be used for multiple purposes. For example, leads used for thermocouple temperature measurements can also be combined with stand-alone leads for conductivity or impedance measurements. When the system measures temperature, current passes only between the thermocouple leads. When the system measures conductivity, current passes between the thermocouple leads and the stand-alone conductivity electrode.

[0374] Similarly, optical sensors can utilize image analysis to detect light scatter / absorption and cell count. In this example, light scatter / absorption can be measured from an optical image that is analyzed by a microprocessor on a patient monitoring device or a microprocessor in a database server system. The image can be analyzed for overall light scatter / absorption by color gradient, gray gradient, or other methods. The same image can also be analyzed to count individual cells.

[0375] Sensor data can also be used in combination to provide contextual data. For example, flow rate can be determined by using flow sensor measurements. Flow sensor data and timestamp data can be used to determine the total residence time of fluid replaced for a peritoneal dialysis patient. Flow rate and residence time can be used to normalize data generated by conductivity sensors, urea sensors, glucose sensors, and / or other sensors for analyte concentration. Similarly, flow rate and residence time can be used to normalize data generated by a fluid light scattering / absorption sensor or a cell counter.

[0376] Sensor sampling rate

[0377] Each sensor can operate at a variety of sampling frequencies and duty cycles. To conserve power usage for the entire system, it is desirable for each sensor to operate only when necessary. A primary sensor like a flow sensor may operate continuously, but at a lower duty cycle during periods when there is no fluid flow. Then, during periods when there is fluid flow, the flow sensor will operate at a higher duty cycle setting. The sampling rate will be optimized for sensor performance as needed. The sampling frequency of a flow sensor may only operate at 1Hz when there is no flow and increase to 10Hz when flow starts again.

[0378] Auxiliary sensors such as conductivity sensors or pH sensors may only measure the fluid for a few seconds during the beginning and end of dialysis infusion and drain cycles because solutions typically have uniform pH and conductivity so that a portion of the volume of solution drained or infused is representative of the total volume of the fluid.

[0379] The sampling rate of the sensor can also be used to identify inhomogeneous components. For example, a high sampling rate can be used to acquire inhomogeneous mixed particles (e.g., fibrin) that have very few signal peaks by fluid light scattering / absorption when compared to a homogeneous mixed particle (e.g., white blood cells) that has a constant signal.

[0380] Data processing and alarm generation

[0381] Thereafter, all sensor-based data, patient-entered data, and healthcare provider-entered data will be categorized as "patient data". The database server system receives, stores, and processes patient data, and then allows patient and healthcare provider software to retrieve information through secure protocols. In one variation, the database server determines patient-specific historical baseline metrics over a specified time period. As patient data is retrieved over time, the database identifies data points that deviate from the baseline metrics and signals an alert to the healthcare provider and / or patient.

[0382] In one example of this variation for patients on peritoneal dialysis therapy, the conductivity of the drain dialysate solution is measured by voltage and represents the amount of solutes diffused through ultrafiltration (UF). The conductivity is monitored during the patient's initial six-week UF stabilization period, and a baseline conductivity mean and standard deviation value is determined. In the following weeks, when the patient's conductivity value is above or below a predetermined number (e.g., two) standard deviations of the baseline mean, an alert is sent to the health care provider via a user interface software system GUI, an email message, a text on a desktop or mobile device, a push notification on a mobile device, or other communication methods. The alert can also be included in the patient's health care provider's electronic medical record (EMR) via, for example, an application programming interface.

[0383] In another example, the database alerts the health care provider and / or patient when patient data changes abruptly within a specific monitoring period. For patients undergoing peritoneal dialysis treatment, intraperitoneal pressure may be measured during a dialysate dwell period or when flow is stopped between dialysis cycles. Temporary changes in pressure may be measured, for example, by calculating a moving average during a monitoring period, and any reading outside of three standard deviations (or other suitable predetermined threshold) may be detected and trigger an alarm.

[0384] In another example, the database alerts the health care provider and / or patient when the patient data has exceeded an absolute predetermined range. In one example of this variation, the skin surface temperature of a patient with a PICC line is monitored. Any temperature value outside the standard physiological range [97.7–99.5°F] (or other suitable range) may trigger an alarm to the health care provider and / or patient.

[0385] In another example, a health care provider enters a prescribed patient therapy into a user interface software system, and the data is sent and stored by a database server. A sensor network monitors the start infusion time, infusion volume, and in some cases, the start drainage time of the patient's therapy. When the total number of daily infusion / drainage cycles, infusion volume, infusion start time, dwell time, and other prescription parameters exceed the prescribed therapy, an alert is issued to the health care provider and / or the patient.

[0386] One or more data inputs can be used to determine statistical alarm limits to monitor the following: a) patient compliance with prescribed therapy, b) treatment effectiveness, c) complication detection, d) sensor calibration, e) equipment cleaning, and / or f) component replacement (e.g., cartridge replacement). In one example, for patients undergoing peritoneal dialysis, the dialysate ultrafiltration effect is monitored by the ratio of the dialysate infusion flow to the drainage flow, Vi / Vw, and the difference between the conductivity of the dialysate drainage solution and the conductivity of the fresh dialysate solution, Ci-Cw. An alarm can be triggered when either of the two parameters monitoring the dialysate ultrafiltration effect exceeds the statistical alarm limit, or when both parameters exceed the statistical alarm limit. When two parameters are used, the weighting of each parameter may be different. For example, the alarm limit for the flow ratio is based on one standard deviation of the baseline mean, while the conductivity difference is based on three standard deviations of the baseline mean.

[0387] In addition to the statistical limits of the data values, the alarm sensitivity can also be controlled by the number of times the data value deviates from the statistical limit. For example, a highly sensitive alarm will only require one data value deviating from the statistical limit to trigger the alarm. A low sensitivity system may require multiple data values ​​deviating from the statistical limit to trigger the alarm.

[0388] The alarm sensitivity can be based on a predetermined value, or customized by a health care provider. For example, a health care provider can customize the alarm sensitivity based on the patient's condition. In the case of a dialysis patient with the worst renal function (high flow differential) and poor overall health, the health care provider can conservatively set the statistical limit to one standard deviation and trigger an alarm when one data instance deviates from the statistical limit. In the case of a dialysis patient with moderate renal disease (low flow differential) and good overall health, the health care provider can set the statistical limit to three standard deviations and trigger an alarm when four data instances deviate from the statistical limit.

[0389] In an alternative variation, the database server system may analyze the patient information to determine the patient's overall health status as a patient profile, and adjust the alarm sensitivity accordingly. The patient alarm sensitivity may remain constant, or vary over time. For example, a patient's flow differential data may be low, and the patient has no recorded instances in his or her patient complication profile, so the database server adjusts the alarm's sensitivity level to a low setting. After a period of time, the patient's flow differential data increases to a high level, and the patient has two recorded instances of infection in his or her patient profile. Therefore, the database server adjusts the alarm's sensitivity level to high.

[0390] Alert Type

[0391] When an alarm is triggered, the alarm may simply present data and / or an assessment of the patient's condition. For example, a temperature anomaly may be displayed in an alarm as "Patient X's temperature is 101.1°F," or alternatively as "Patient X may have a fever."

[0392] Multiple data can be combined in an alert to monitor the following: a) patient compliance with prescribed therapy, b) dialysate ultrafiltration effectiveness, and c) complication detection. For example, a patient infection can be indicated by a patient with an elevated core temperature and a decreased dialysate pH. In this example, the alert can summarize the two inputs as "patient is at high risk for infection."

[0393] Alarms can also indicate severity levels by using different audio, vibration, or visual cues (such as color-coded pop-ups in the software GUI). Severity is determined by the monitoring category as well as the size of the statistical deviation. For example, a deviation in patient compliance (such as when a patient attends dialysis later than prescribed) will result in a low-severity alarm. Consecutive numbers of missed dialysis visits may result in higher-severity alarms. A high temperature exceeding 105°F and a four-standard-deviation drop in pH would warrant an extremely severe alarm.

[0394] In another variation, the server and / or device processor can be configured to determine the critical emergency of the patient's condition and trigger additional actions. In one example of a patient using a urinary catheter, the temperature sensor measures a skin surface temperature of 110°F and the accelerometer detects the patient's minimal movement over a 24-hour period. In addition to sending a high severity alert to a health care provider, the system also triggers a call to emergency personnel.

[0395] Alarms can be communicated within the user interface or via phone, text message, email, or stand-alone alarm hardware installed at the dialysis clinic. Depending on the severity of the alarm, one or more communication methods can be used. In addition, health care providers and / or patients can customize alarm communication preferences.

[0396] In some variations, the database server may limit functionality of the patient monitoring device if the user does not respond to an emergency alert (eg, an emergency alert to replace a cartridge / disposable component).

[0397] False positive / negative alarm avoidance

[0398] Typically, certified nurse practitioners are the primary health care providers and monitor approximately 15-20 peritoneal dialysis patients at any given time point. Due to their time constraints, it is desirable that the system limit false positive alarms, which waste the time of patients and health care providers. One of the main false positive drivers is non-leukocyte particles, which can increase the turbidity of the effluent caused by non-infection related reasons. For example, red blood cells, proteins, triglycerides, and fibrin are common false positive drivers associated with turbidity. However, as described herein, particle types can be distinguished based on optical measurements performed in different wavelength ranges and the ratios calculated therefrom to improve leukocyte concentration measurements.

[0399] One or more redundant sensors may also be used to avoid or reduce the frequency of false positive conditions. In the case of monitoring the effect of dialysate ultrafiltration, a conductivity sensor may be used in addition to a flow sensor that determines the flow difference. The flow difference primarily measures the diffusion of water during ultrafiltration, and conductivity primarily measures the diffusion of salt during ultrafiltration. In the case of changes in ultrafiltration due to changes in peritoneal permeability, the measured solute, water, and salt concentrations should be affected. Thus, the process may take into account changes in flow difference and conductivity before triggering an alarm. Fig.51 Depicts a logical flow utilizing flow differentials and conductivity changes, where both sensor systems need to demonstrate a change before an alarm is triggered.

[0400] False positives can also be avoided or reduced by unique sensors that monitor for false positive situations. For example, pressure monitoring for complications of a patient hernia or catheter obstruction can be supplemented by the use of an accelerometer. A patient hernia can result in, for example, rapid pressure changes. However, a patient's cough may similarly show rapid pressure changes. In this use case, an accelerometer integrated into the patient monitoring device can be used to detect a cough, which typically results in sudden movements of the abdomen and diaphragm. Thus, the accelerometer can filter the pressure sensor data to avoid false positives. Fig.52 Depicts the logic flow of pressure sensor data and accelerometer cough detection to filter data or trigger an alarm.

[0401] Another false positive situation may occur when the patient exercises. During exercise, intraperitoneal pressure may rise, respiratory cycle frequency increases, and pressure sensor data may indicate patient complications. Accelerometers and / or gyroscopes may be used in conjunction with pressure sensors to detect when a patient is exercising due to the detected continuous motion, and the pressure data may be filtered out during exercise.

[0402] In addition, the system can be configured to increase the sensitivity for detecting certain states to avoid or reduce the risk of missing patient infections, which may, for example, lead to long-term hospitalization or patient morbidity. Redundant sensors can also be used to avoid or reduce false negative states. Systems designed to avoid false negatives are particularly useful in cases where detectability is low. Different pathogens, different types of infections, and different patient physiological conditions result in different expressions of infection. Therefore, multiple sensors can be used for infection detection. In one example, a pH sensor can be used in combination with a light scattering / absorption sensor and a temperature sensor. During infection, a patient may not indicate infection through all three parameters, so changes in any sensor can trigger an alarm. Fig.53 An exemplary process for light scattering / absorption sensors, temperature sensors, and pH sensors is depicted, where any sensor can trigger an alarm. Fig.73 A variation of a GUI is depicted that is configured to set the sensitivity of an alarm level based on one or more parameters such as turbidity (7316), fluid flow (7318), ultrafiltration conductivity (7320), ultrafiltration flow rate (7322), etc. For example, a healthcare provider can manipulate a slider (7312) along a predetermined scale (7310) to adjust the sensitivity level (7314) of the alarm.

[0403] In addition, when a specific complication is detected, the user (e.g., patient, health care provider) can be prompted to answer several questions through a graphical user interface to reduce false positive conclusions. For example, an optical sensor can detect abnormal signals due to a new infection but also due to the patient's unnatural diet. The patient can be asked through the user interface or other communication medium whether there is any abnormal behavior that may cause the signal change (e.g., eating a lot of meat when usually adapted to a vegetarian diet). The alarm and subsequent patient's answer can be recorded in the historical data, but the health care provider may be alerted only when the patient states that there is no abnormal behavior.

[0404] Additionally, the data can be time resolved to screen for false positives. For example, if an infection is present, the infection will result in an elevated white blood cell concentration which will likely remain constant or increase over time. For each patient, a false positive alarm may be generated after one abnormal signal reading, but the indicator may drop to normal levels on the next reading. For each patient, the time resolved signal behavior of false positives can be understood. Increased ultrafiltration has also been associated with the development of peritonitis. An increase in ionic conductivity in parallel with an increase in light scattering / absorption readings is another indicative parameter for the onset of infection.

[0405] Sample collection method

[0406] The system can also prompt other actions when certain threshold action limits are detected. In one example, a sterile collection container can always be loaded in the device for fluid sample collection, which can be sent to a laboratory for analysis. When a potential complication is detected, the patient's fluid sample can be collected in a container. The container can also be labeled for shipping and ejected from the device or removed by the patient. The sample can then be placed directly in a mailbox for delivery to an analytical facility or automatically have a delivery service pick up the mail from the patient's home.

[0407] As part of the sample collection, an independent sample can be collected to be tested in the device using a test strip or another test method for identification of common pathogens. The test results can then be provided to a health care provider or an analytical laboratory to speed up the analysis process by providing initial data on the identity of the pathogen causing the complication. Therefore, the initial screening of the sample can be completed before arriving at the analytical device. In some variations, the optical sensor can measure one or more optical properties (e.g., image, color) of the test indicator strip, and the sensor signal is automatically transmitted to one or more of the memory, network, database, and service provider.

[0408] In another example, an alert can notify the device manufacturer, health care provider, analytical laboratory, delivery service, or third-party service to collect the sample. During the drainage process or in a previous drainage, a person may be sent to the patient and collect the sample directly. Additionally or alternatively, the test strips can be stored in the device and the dispatched person can use the device to test for common pathogens, or the results of the test strips used automatically can be read.

[0409] After the sample is collected, an alarm may be triggered to generate a cascade. Notifications (e.g., text, email, application notifications) may be sent to health care providers and analytical institutions to warn them of patient status and samples to be tested that are about to arrive. In one example, an alarm may be sent to the delivery service to take away the sample so that the patient does not need to put the sample in a mailbox. Alternatively, the patient can put the sample in a mailbox or another container outside so that the delivery service personnel can obtain the sample without coordinating with the patient and reducing the total transportation time of the sample. When the sample arrives at the testing agency, the result is known and reaches the key inspection procedure for the treatment of the patient's complications, a notification may be triggered subsequently.

[0410] The delivery service personnel may have unique access to the sample container to ensure test fidelity and patient safety. The device may contain a locked compartment that holds the sample and can be opened by the authorized delivery service personnel. The delivery service personnel can then replace the sample into the device with a new sample collection container.

[0411] Fig.56A series of possible notifications are shown. After the sample collection container (110) is filled and sealed for transport, a notification (111) is sent to the delivery service (112) to obtain the sample, a notification (111) is sent to the medical staff (113) to inform them, and a notification (111) is sent to the analytical laboratory (114) to inform them of the upcoming test. When the delivery service obtains the sample, the health care provider and the analytical facility are notified again. The health care provider is then notified when the delivery service drops the sample off at the analytical facility and when the test results are known (115). As treatment of complications continues, the health care provider is informed of the checkup procedures (116) as the patient's treatment progresses.

[0412] As part of the automated response cascade, a treatment regimen may be initiated immediately after sample collection. For example, for an infection, the treatment regimen may be a broad-spectrum antibiotic, for a catheter obstruction, the treatment regimen may be a thrombolytic. In either case, the therapeutic substance may be automatically injected into an infusion fluid line for delivery to the patient, or may be in a locked container accessible to the patient that may be unlocked remotely or automatically, or by an access code sent to the patient. For therapeutic substances that are not injected directly into the fluid (e.g., when there is only a drainage tube), the therapeutic substance may be administered orally, via a catheter, via a syringe, via a transdermal patch, etc. Fig.57A -C and Fig.58A -C depicts a treatment regimen initiated after sample collection but not as part of the autoresponse cascade.

[0413] In another example, when the action limit of a potential complication (e.g., infection or catheter blockage) is detected, the system can alert the pharmacy to deliver antibiotics to treat the infection, or deliver thrombolytics to address the catheter blockage. The health care provider may be notified by the alert and can send a remote prescription to the patient through the device application or user interface to initially use broad-spectrum antibiotics and then use more specific antibiotics when they get results from sample analysis or observe low or no efficacy. Remote prescriptions can be used in conjunction with test strips or other testing methods in the device for common pathogens to increase information for the health care provider to use when prescribing.

[0414] Therapeutic methods

[0415] Figures 58A-58C A variation of the method is depicted in which the therapeutic agent is injected directly into a fluid entering the patient's body. Fig.57A Similar, such as Fig.58A As shown, the injectable therapeutic agent (119) is initially prot...

Claims

1. A patient monitoring device comprising: a housing configured to removably engage a fluid conduit; at least one sensor configured to measure at least one property of a fluid flowing through the fluid conduit; and A controller configured to: generating patient data including a baseline range of the at least one characteristic during a first time period; and The patient state is monitored during a second time period based at least in part on the baseline range and the measured at least one characteristic.

2. The patient monitoring device according to claim 1, wherein: The at least one characteristic includes one or more of light scatter, absorbance, color, flow rate, conductivity, temperature, pH, lactate concentration, cell number, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration.

3. The patient monitoring device according to claim 1, wherein: The at least one characteristic comprises leukocyte esterase concentration.

4. The patient monitoring device according to claim 1, wherein: The housing includes a hinge and is configured to surround at least a portion of the fluid conduit.

5. The patient monitoring device according to claim 1, wherein: The fluid conduit includes a rigid curved end configured to removably attach the fluid conduit to a drainage container such that the housing is detachable from the drainage container.

6. The patient monitoring device according to claim 1, wherein: The at least one sensor is configured to be clipped onto a portion of the fluid conduit that is transparent to at least one of ultraviolet light, visible light, and infrared radiation.

7. The patient monitoring device according to claim 1, wherein: The at least one sensor is a fluid contact sensor.

8. The patient monitoring device of claim 1, further comprising a limited use sensor configured to removably engage one or both of the fluid conduit and the housing.

9. The patient monitoring device according to claim 8, wherein: The controller is configured to detect whether the limited use sensor has expired based at least in part on the measured flow rate.

10. The patient monitoring device according to claim 1, wherein: The fluid conduit is coupled to one or more of an indwelling catheter for peritoneal dialysis, a urinary catheter, a hydrocephalus shunt, a percutaneous abscess drainage catheter, an ascites drainage catheter, an insulin pump, a feeding tube, a central venous catheter, a tunneled catheter, and an implanted access port.

11. A method for monitoring an infection in a patient, comprising: measuring at least one characteristic of a bodily fluid of a patient during a first period of time; measuring the at least one characteristic of the patient's bodily fluid during a second time period after the first time period; generating patient data including a baseline range of the at least one characteristic during the first time period; and A patient state is monitored during the second time period based at least in part on the baseline range and the measured at least one characteristic.

12. The method according to claim 11, wherein: The at least one characteristic includes one or more of light scattering, light absorption, flow rate, conductivity, temperature, pH, lactate concentration, cell number, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration.

13. The method according to claim 11, wherein: The at least one characteristic comprises leukocyte esterase concentration.

14. The method according to claim 11, comprising: measuring a set of patient clinical events during said first time period and during said second time period after said first time period; evaluating a relationship between the set of patient clinical events and the at least one characteristic during the first time period; The patient state is monitored during the second time period based at least in part on the estimated relationship and the measured characteristic.

15. The method according to claim 11, further comprising: When the characteristic measured during the second time period deviates from the baseline range, an alert is output to a predetermined contact.

16. The method of claim 11, further comprising modifying alarm sensitivity based on one or more of a certain number of patient clinical events and a certain number of deviations from the baseline range.

17. The method according to claim 11, wherein: The patient status includes one or more of the patient's infection status, patient compliance with prescribed therapy, treatment effectiveness, device maintenance, sensor calibration, and sensor data.

18. The method according to claim 11, further comprising: In response to an alert corresponding to the patient being in a high risk condition, a communication channel is established between the patient and a health care professional.

Images