System and method for analyzing used dialysate

Abstract

An apparatus for analyzing used dialysate includes at least one first surface configured to receive a dialysate drainage bag in a first predetermined position and at least one second surface configured to receive a dialysate analysis device in a second predetermined position, such that when the dialysate drainage bag is in the first predetermined position and the dialysate analysis device is in the second predetermined position, a light sensor of the dialysate analysis device is positioned to sense light transmitted through the dialysate drainage bag.

Description

Background Technology

[0001] Peritoneal dialysis is a renal replacement therapy for patients with kidney disease. Techniques used for peritoneal dialysis include continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). CAPD is performed continuously, and used dialysate is drained into a drainage bag, which is then discarded and replaced. APD uses a circulation machine to deliver and drain dialysate and is typically performed when the patient is at rest (e.g., while sleeping). In APD, used dialysate can be drained into a bag, a sink, or other location.

[0002] Because peritoneal dialysis uses the peritoneum, it is a risk factor for peritonitis. For example, peritoneal dialysis can accidentally introduce bacteria into the abdomen. According to some statistics, a peritonitis incident occurs approximately once every 24 to 48 patients per month. Peritonitis is a leading cause of death and treatment failure in peritoneal dialysis patients. Rapid diagnosis and treatment are crucial for treatment success.

[0003] Due to the risks associated with peritonitis, monitoring the symptoms and indicators of peritonitis in peritoneal dialysis patients is important. Indicators of peritonitis include, for example, an increased white blood cell (WBC) count and differentiation. Used dialysis fluid (e.g., in the drainage bag) can provide indicators of peritonitis. These indicators can even be visually apparent as peritonitis progresses. For example, used dialysis fluid may appear cloudy. Turbidity can be assessed using various manual techniques, such as placing a newspaper under the drainage bag and assessing whether the characters are difficult to read. When used dialysis fluid appears cloudy, patients should be encouraged to undergo another drainage and bring the recently drained drainage bag to the clinic for testing. In some cases, patients can send a photo of the used dialysis fluid to their clinician for a subjective assessment based on its appearance. However, relying on this technique means that peritonitis may not be detected until later in the infection, especially for patients with visual impairments, making it even more difficult for them to subjectively assess the “turbidity” of the used dialysis fluid. It is estimated that more than 60% of peritoneal dialysis patients have visual impairments.

[0004] As a passive measure, antibiotics can be administered to patients before clinicians have the opportunity to properly test the used dialysis fluid. While the patient is on antibiotics, the clinician sends the used dialysis fluid to the laboratory for white blood cell count and bacterial testing. Based on the laboratory results, the clinician may continue, discontinue, or modify the patient's antibiotic treatment. Therefore, the traditional method of monitoring peritonitis is passive, inefficient, and may delay appropriate drug treatment. Furthermore, in cases of false positives, the traditional method may lead to unnecessary and / or partial antibiotic treatment.

[0005] One or more methods described herein can be combined with the findings and techniques described in (a) "Particle Sizing with a Smartphone" (2014) by Carlson, D. and Van Brackle, C. and / or (b) "Blood Cell Counting and Classification by Nonflowing Laser Light Scattering Method" by Yang, Ye et al., Advanced Photonic Sensors and Applications, Vol. 3897, International Society for Optics and Photonics, 1999.

[0006] Prior to the filing of this application, the methods described in this section were not necessarily conceived and / or practiced. Therefore, unless otherwise stated, the methods described in this section should not be construed as prior art. Summary of the Invention

[0007] One or more embodiments allow for earlier diagnosis of peritonitis than conventional methods. The systems and methods described herein allow for bedside (e.g., at-home) analysis of used dialysis fluid by detecting peritonitis-related indicators such as white blood cell count, differentiation, and / or bacteria. The techniques described herein can detect such indicators even when the patient is not experiencing or aware of related symptoms (e.g., abdominal pain). Early diagnosis allows for faster treatment of peritonitis while avoiding inappropriate treatment in cases of false positives. The techniques described herein allow patients to monitor peritonitis using objective measurements, rather than relying on subjective observations such as “turbidity.” For example, one or more embodiments provide a device that helps ensure consistent measurement conditions across multiple uses. Furthermore, the techniques described herein can be combined with other medical monitoring and diagnostic techniques to provide a versatile tool for monitoring peritoneal dialysis patients. Additionally, one or more embodiments can be used to analyze used dialysis fluid during and / or after antibiotic treatment to predict or assess treatment effectiveness. One or more embodiments utilize smartphones, tablets, or other computing devices already owned by the patient, thereby reducing the costs that might otherwise be associated with the techniques described herein. Compared to traditional techniques that require contacting a clinician's office and potentially sending used dialysate to a laboratory for analysis, the technique described herein can be performed in seconds (e.g., approximately 30-40 seconds).

[0008] In general, in one aspect, an apparatus includes at least one first surface configured to receive a dialysate drainage bag at a first predetermined position. The apparatus also includes at least one second surface configured to receive a dialysate analysis device at a second predetermined position, such that when the dialysate drainage bag is in the first predetermined position and the dialysate analysis device is in the second predetermined position, a photosensitive sensor of the dialysate analysis device is positioned to sense light passing through the dialysate drainage bag. The apparatus may further include a light-emitting device configured to emit light that travels through the dialysate drainage bag to the photosensitive sensor of the dialysate analysis device. The light-emitting device may also be configured to operate in response to an instruction sent by the dialysate analysis device. The apparatus may further include a scale configured to measure the weight of the dialysate drainage bag when the dialysate drainage bag is in the first predetermined position. The apparatus may also be configured to transmit the weight of the dialysate drainage bag to the dialysate analysis device. The apparatus may further include a wireless device configured to communicate with the dialysate analysis device. The dialysate analysis device may be a smartphone. The first surface and the second surface may be vertical surfaces of the molded body of the device.

[0009] In another aspect, a system includes a light-transmitting chamber removably arranged along a dialysate drainage tube and configured to receive a used portion of dialysate flowing through the drainage tube. The system also includes a light-sensing device operatively coupled to the light-transmitting chamber and configured to measure the transmittance of the used dialysate portion within the light-transmitting chamber. The system further includes one or more non-transitory computer-readable media storing instructions that, when executed by one or more processors, cause the dialysate analysis device to measure the turbidity of the used dialysate portion, at least based on the transmittance. The instructions, when executed by one or more processors, can also cause the dialysate analysis device to assess the used dialysate portion, at least based on the turbidity, to determine the presence of peritonitis. The photosensitive device may include a light source configured to emit near-infrared light that passes through a used portion of dialysate in a light-transmitting chamber. The photosensitive device may also be configured to measure the transmittance of the near-infrared light passing through the used portion of dialysate in the light-transmitting chamber, and the instructions, when executed by one or more processors, may also enable the dialysate analysis device to determine the glucose concentration in the used portion of dialysate based at least on the transmittance of the near-infrared light. The photosensitive device may include a clamping mechanism comprising a light source and a photosensor. When the clamping mechanism is operatively coupled to the light-transmitting chamber, the light source and photosensor may contact opposing surfaces of the light-transmitting chamber. The photosensitive device may also be configured to wirelessly transmit data to the dialysate analysis device. The light-transmitting chamber may be a disposable, single-use chamber.

[0010] In another aspect, a system includes a light-transmitting chamber removably arranged along a dialysate drainage tube and configured to receive a used portion of dialysate flowing through the drainage tube. The system also includes a light-sensing device operatively coupled to the light-transmitting chamber. The light-sensing device includes a light source and a light sensor, the light source configured to emit near-infrared light that passes through the used portion of dialysate in the light-transmitting chamber, and the light sensor configured to measure the transmittance of the near-infrared light passing through the used portion of dialysate in the light-transmitting chamber. The system also includes one or more non-transitory computer-readable media storing instructions that, when executed by one or more processors, cause the dialysate analysis device to determine the glucose concentration in the used portion of dialysate based at least on the transmittance of the near-infrared light. The instructions, when executed by one or more processors, may also cause the dialysate analysis device to measure the turbidity of the used portion of dialysate based at least on the transmittance of the used portion of dialysate passing through the light-transmitting chamber. When executed by one or more processors, the instructions can also cause the dialysate analysis device to assess the used dialysate portion, at least based on the turbidity, to determine whether peritonitis is present. The photosensitive device may include a clamping mechanism comprising a light source and a light sensor. When the clamping mechanism is operatively coupled to the light transmission chamber, the light source and light sensor may contact the opposing surface of the light transmission chamber. The photosensitive device may also be configured to wirelessly transmit data to the dialysate analysis device. The light transmission chamber may be a disposable, single-use chamber.

[0011] In another aspect, a method includes: a light sensor sensing light emitted through a drainage bag containing used peritoneal dialysis fluid; a dialysis fluid analysis device determining an estimated proportion of white blood cells in the used peritoneal dialysis fluid based at least on the light emitted through the drainage bag; and the dialysis fluid analysis device determining the risk of peritonitis based at least on the estimated proportion of white blood cells in the used peritoneal dialysis fluid. The method may further include: aligning a light sensor with the drainage bag using a device configured to indicate a desired position of the light sensor relative to the drainage bag before sensing the light emitted through the drainage bag. The method may further include determining the weight of the drainage bag. Determining the risk of peritonitis may also be based on the weight of the drainage bag. The method may further include calibrating the dialysis fluid analysis device to obtain a reference light reading. Determining the estimated proportion of white blood cells in the used peritoneal dialysis fluid may include determining the difference between the reference light reading and the light emitted through the drainage bag. The method may further include: the dialysis fluid analysis device determining an estimated proportion of polymorphonuclear cells in the used peritoneal dialysis fluid. Determining the risk of peritonitis may also be based on the estimated proportion of polymorphonuclear cells in the used peritoneal dialysis fluid. Determining the estimated proportion of polymorphonuclear cells in used peritoneal dialysis fluid may include analyzing one or more of the following: (a) data corresponding to light scattering through the used peritoneal dialysis fluid using a dialysis fluid analysis device and (b) images from a lateral flow test or dry chemical strip.

[0012] This overview section may not include one or more embodiments described in this specification and / or listed in the claims. Attached Figure Description

[0013] At least one embodiment is described below with reference to the accompanying drawings, which are not necessarily drawn to scale. The purpose of including the drawings is to provide illustration and further understanding of the aspects and embodiments, and the drawings are incorporated in and form part of this specification, but are not intended to limit the scope of this disclosure. In the drawings, each identical or substantially identical component shown in the various figures is designated by the same reference numerals. For clarity, some components may not be labeled in every figure. In the drawings:

[0014] Figure 1A-1B This is a block diagram of an example of a system according to one embodiment;

[0015] Figure 2A This is a perspective view of an example of a device according to one embodiment;

[0016] Figure 2B According to one embodiment, it is without a lamp compartment. Figure 2A A top view of the equipment;

[0017] Figure 2C According to one embodiment, a lamp housing Figure 2AA top view of the equipment;

[0018] Figure 2D According to one embodiment, it is used for Figure 2A A perspective view of an instance of the device's light compartment;

[0019] Figure 2E According to one embodiment, it is used for Figure 2D A perspective view of an example of the cover of a lamp compartment;

[0020] Figure 2F According to one embodiment Figure 2D A top view of the lamp holder;

[0021] Figure 2G According to one embodiment, it is used for Figure 2D A top view of the electrical component layout of the lamp compartment;

[0022] Figure 2H According to one embodiment Figure 2A Another perspective view of the device;

[0023] Figure 2I According to one embodiment Figure 2A A bottom view of the equipment;

[0024] Figure 3A This is a perspective view of another instance of a device according to one embodiment;

[0025] Figure 3B According to one embodiment Figure 3A A top view of the equipment;

[0026] Figure 4 This is a flowchart illustrating an example of an operation for analyzing used dialysis fluid in a drainage bag, according to one embodiment.

[0027] Figures 5A-5D This is an illustration of an example of a graphical user interface according to one embodiment;

[0028] Figure 6A This is a schematic diagram of an example of a light-transmitting chamber according to one embodiment;

[0029] Figure 6B This is a schematic diagram of an example of a light sensing device according to one embodiment;

[0030] Figure 7 This is a flowchart illustrating an example of an operation for analyzing used dialysis fluid in a drainage tube, according to one embodiment.

[0031] Figures 8A-8E This is a schematic diagram of another example of a graphical user interface according to one embodiment;

[0032] Figure 9 This is a block diagram of an example of a computer system according to one embodiment;

[0033] Figure 10 This is a block diagram of an example of an interconnected health system according to one embodiment; and

[0034] Figure 11 The graph shows test results demonstrating the correlation between relative luminescence and leukocyte concentration. Detailed Implementation

[0035] The following table of contents is provided for the convenience of the reader and is not intended to limit the scope of this disclosure.

[0036] 1. System Configuration

[0037] 2. Analyze the used dialysis fluid in the drainage bag.

[0038] 3.1. Equipment

[0039] 3.2. Methods

[0040] 3.3. User Interface

[0041] 3. Analyze the used dialysis fluid in the drainage tube.

[0042] 3.1. Equipment

[0043] 3.2. Methods

[0044] 4. User interface for patient tracking

[0045] 5. Others; Extensions

[0046] 6. Computing equipment

[0047] 7. Computer Networks

[0048] 8. Connected Health System

[0049] 1. System Configuration

[0050] In general, one or more embodiments include a bedside (POC) system configured to analyze used peritoneal dialysis fluid. Figure 1A-1B This is a block diagram of an example of a system according to one embodiment. The system may include, for example, a system with... Figure 1A-1B The examples shown may contain more or fewer components. The components shown in these examples may be local or remote. The components shown in these examples may be implemented using software and / or hardware. Each component may be distributed across multiple applications and / or machines. Multiple components may be combined into one application and / or machine. Operations described with respect to one component may be performed by another component.

[0051] like Figure 1A As shown, one example of system 100 includes a light source 102 configured to emit light 104 through used dialysate 106. For example, the used dialysate 106 may be located in a drainage bag or drainage tube. The light source 102 may be ambient light (e.g., sunlight and / or one or more general-purpose lamps) in the environment in which system 100 is located. Alternatively, the light source 102 may be a dedicated light source for analyzing used dialysate. For example, the light source 102 may include one or more light-emitting diodes (LEDs) and / or lasers housed in a device, such as one of the exemplary devices described herein. Compared to relying on ambient light, a dedicated light source 102 can provide a more consistent light emission direction, intensity, and / or wavelength, thereby improving the quality and consistency of light readings used in used dialysate analysis.

[0052] In one embodiment, light source 102 is configured to emit light of a single wavelength, which passes through used dialysate 106. Alternatively, light source 102 may be configured to emit light of multiple wavelengths. Light source 102 may be configured to emit light of approximately 1300 nm, approximately 810 nm, and / or approximately 660 nm wavelengths. The emitted light of approximately 1300 nm wavelength can be used for calibration, for example, by emitting light through water or clean dialysate (not shown). The emitted light of approximately 810 nm wavelength can be used to detect hemoglobin in used dialysate 106. The emitted light of approximately 660 nm wavelength can be used to detect leukocytes in used dialysate 106. One or more other wavelengths may be used. In one embodiment, light source 102 is configured to emit near-infrared light, which can be used to detect glucose concentration in dialysate, as further detailed below.

[0053] In one embodiment, the light sensor 108 is configured to sense light transmitted through the used dialysate 106. Specifically, the light sensor 108 is configured to sense the transmittance of the used dialysate 106. The light sensor 108 may be located generally opposite the light source 102, with the used dialysate 106 located between them. Some embodiments can perform better (i.e., obtain more reliable light measurements) if the system 100 is placed in a darker environment (e.g., a dark room) and / or if the light sensor 108 is placed within a housing that substantially blocks light from sources other than the light source 102.

[0054] In one embodiment, the dialysate analysis device 110 is configured to analyze used dialysate 106 using data from the light sensor 108. The dialysate analysis device 110 may be a multi-purpose computing device, such as a smartphone, tablet, laptop, desktop computer, or other type of multi-purpose device. For example, the dialysate analysis device 110 may be configured to execute an installable application that includes instructions for analyzing used dialysate 106 based on data from the light sensor 108. Alternatively, the dialysate analysis device 110 may be a dedicated medical device configured to analyze used dialysate 106. For example, the dialysate analysis device 110 may be part of a peritoneal dialysis (PD) circulation machine and / or other types of dialysis devices.

[0055] In one embodiment, the light sensor 108 is part of the dialysate analysis device 110, such as Figure 1A As shown. For example, the light sensor 108 may be a camera or other type of light-sensing component that is part of a smartphone, tablet, or dedicated medical device. Alternatively, the light sensor 108 may be physically separate from the dialysate analysis device 110. For example, the light sensor 108 may be coupled to or near a clean section of the drainage tube or to or near a chamber arranged along the drainage tube (e.g., in...). Figure 6B As part of the device shown in the example, the physically separate optical sensor 108 can be configured to transmit via cable (e.g., a Universal Serial Bus (USB) cable, an Apple Lightning cable, an Ethernet cable, and / or another type of cable) and / or via one or more wireless transmission protocols (e.g., ...). The dialysate analyzer 110 communicates with the dialysate analyzer 110 via Wi-Fi or other means. For example, if the dialysate analyzer 110 includes a light-sensing component (such as a smartphone camera) but does not include an application programming interface (API) that allows full access to data from the light-sensing component, then a physically separate light sensor 108 may be helpful.

[0056] In one embodiment, the dialysate analysis device 110 includes one or more additional hardware components configured to collect dialysis-related data and / or communicatively coupled to said additional hardware components. For example, the dialysate analysis device 110 may include a microscope (not shown) or be communicatively coupled to a microscope. The microscope may be a camera, a camera magnification accessory, or part of a physically separate microscope assembly. For example, a smartphone accessory may be used to magnify a smartphone camera to approximately 400x or other suitable magnification. The dialysate analysis device 110 may use images from the microscope to aid in the detection and analysis of Gram-stained bacteria in used dialysate 106.

[0057] As another example, the dialysate analysis device 110 may include a proximity sensor (not shown) or be communicatively coupled to a proximity sensor. The dialysate analysis device 110 may use the proximity sensor to help detect the proximity of the dialysate analysis device 110 relative to a certain device (e.g., Figure 2A The exemplary device 200 shown in the figure) and / or relative to a specific part of the device (e.g. Figure 2A The device placement area 206 shown is used for placement. The proximity sensor can be based on a radio frequency identification (RFID) chip, The transmitter and / or other components of the device are used to detect approach to a specific location.

[0058] As another example, the dialysate analysis device 110 may include a gyroscope (not shown) or be communicatively coupled to a gyroscope. The dialysate analysis device 110 may use the gyroscope to detect movement of the dialysate analysis device 110, and the movement data may be used to generate visual and / or audible commands that help the patient or other human operator guide the dialysate analysis device 110 to a specific location (e.g., Figure 2A The device placement area 206 shown.

[0059] In one embodiment, the dialysate analysis device 110 is configured to combine data from multiple components. For example, the dialysate analysis device 110 may combine data from a gyroscope and a proximity sensor to generate visual and / or audible commands that assist a patient or other operator in guiding the dialysate analysis device 110 to a specific location. One or more components of the dialysate analysis device 110, or one or more components communicatively coupled to the dialysate analysis device 110, can be used for a variety of purposes. For example, the dialysate analysis device 110 may be configured to use data from a camera (e.g., a camera that is part of or physically separate from the dialysate analysis device 110) for light sensing and to obtain images of a lateral flow test or dry chemical strip to be evaluated, as further detailed below.

[0060] In one embodiment, the dialysate analysis device 110 is configured to control the operation of one or more components described herein, such as controlling the operation of the light source 102 and / or the light sensor 108. For example, the dialysate analysis device 110 may be configured to send electrical signals to turn on the light source 102, turn off the light source 102, and / or change the operating parameters of the light source 102 (e.g., brightness, wavelength, etc.). As another example, the dialysate analysis device 110 may be configured to send electrical signals to instruct the light sensor 108 to start or stop sensing light. Application software executing in the dialysate analysis device 110 may determine whether and / or when to send electrical signals to control the operation of these components. For example, the application software may send electrical signals in response to user input (e.g., via user interface 111) to instruct the dialysate analysis device 110 to begin a process for analyzing the used dialysate 106.

[0061] In one embodiment, server 112 is located remotely from dialysate analysis apparatus 110 (e.g., in a separate device and / or data center communicatively coupled to dialysate analysis apparatus 110 via one or more network connections). Server 112 may be configured to perform one or more operations described herein to analyze used dialysate 106 and / or perform other dialysis-related analytical functions (e.g., analyzing data from cameras, microscopes, proximity sensors, gyroscopes, and / or other types of data, or combinations thereof). Dialysate analysis apparatus 110 may be configured to transmit data to server 112 for analysis and receive analysis results from server 112. One or more operations performed by dialysate analysis apparatus 110 as described herein may also be performed by server 112.

[0062] In one embodiment, the dialysate analysis device 110 includes a user interface 111, or is communicatively coupled to the user interface 111. The user interface 111 refers to hardware and / or software configured to facilitate communication between a user and the dialysate analysis device 110. The user interface 111 presents user interface elements and receives input through these elements. The user interface 111 can be a graphical user interface (GUI), a command-line interface (CLI), a touch interface, a voice command interface, and / or any other type of interface or a combination thereof. Examples of user interface elements include checkboxes, radio buttons, drop-down lists, list boxes, buttons, toggle keys, text fields, date and time pickers, command lines, sliders, pages, and forms. Different components of the user interface 111 can be specified using different languages. The behavior of user interface elements can be specified using dynamic programming languages ​​such as JavaScript. The content of user interface elements can be specified using markup languages ​​such as Hypertext Markup Language (HTML), Extensible Markup Language (XML), or XML User Interface Language (XUL). The layout of user interface elements can be specified using stylesheet languages ​​such as Cascading Style Sheets (CSS). Alternatively, various aspects of the user interface 111 may be specified in one or more other languages, such as Java, Python, Perl, C, C++ and / or any other language, or a combination thereof.

[0063] In one embodiment, the user interface 111 is configured to provide audible and / or visual cues, as described below. Audible and / or visual cues can be particularly helpful, for example, when the patient is visually impaired and has difficulty locating the drainage bag and / or dialysate analysis device 110 for effective dialysate analysis by other means. It should be noted that, using conventional “turbidity” methods, it is especially unlikely that visually impaired patients will be able to detect peritonitis in its early stages.

[0064] In one embodiment, the dialysate analysis device 110 and / or server 112 are configured to store data in one or more data repositories 113. A data repository 113 is any type of storage unit and / or device used for storing data (e.g., a file system, database, table collection, or any other storage mechanism). A data repository 113 may include multiple different storage units and / or devices. These multiple different storage units and / or devices may or may not be of the same type, or may or may not be located in the same physical location. Furthermore, the data repository 113 may be implemented or executed on the same computing system as one or more other components of system 100. Alternatively, the data repository 113 may be implemented or executed on a separate computing system from one or more other components of system 100. The data repository 113 may be logically integrated with one or more other components of system 100. Alternatively, the data repository 113 may be communicatively coupled to one or more other components of system 100 via a direct connection or via a network. Alternatively, information may be implemented and / or distributed across any component of system 100.

[0065] In one embodiment, system 100 is located in the patient's home to provide home-based bedside analysis of used dialysis fluid. Alternatively, system 100 may be located in a clinical setting, such as a dialysis center or hospital.

[0066] In one embodiment, one or more components of system 100 are implemented on one or more digital devices. The term "digital device" generally refers to any hardware device that includes a processor. A digital device can refer to a physical device that executes an application or a virtual machine. Examples of digital devices include computers, tablets, laptops, desktops, netbooks, servers, network servers, network policy servers, proxy servers, general-purpose machines, function-specific hardware devices, hardware routers, hardware switches, hardware firewalls, hardware network address translation (NAT) systems, hardware load balancers, mainframes, televisions, content receivers, set-top boxes, printers, mobile handheld terminals, smartphones, personal digital assistants ("PDAs"), wireless receivers and / or transmitters, base stations, communication management equipment, routers, switches, controllers, access points, and / or client devices.

[0067] Figure 1B Another example of system 101 according to one embodiment is shown. For example... Figure 1BAs shown, dialysis is performed using clean dialysate 114. Used dialysate is drained through drainage tube 116 to drainage bag 120. In other embodiments, used dialysate may be discharged to a fixed outlet (e.g., toilet, sink, or other outlet). As the used dialysate is discharged, the light-transmitting chamber 118 is configured to receive at least a portion of the used dialysate. A light source 102 is configured to emit light that passes through the light-transmitting chamber 118, and a light sensor 108 is configured to sense the light emitted through the light-transmitting chamber 118. The light sensor 108 is configured to transmit data to the dialysate analysis apparatus 110. Referring below... Figure 6A This illustrates an example of a light-transmitting chamber 118. The light source 102 and the light sensor 108 can be light-sensing devices (e.g., Figure 6B Part of the exemplary light sensing device 605 shown.

[0068] 2. Analyze the used dialysis fluid in the drainage bag.

[0069] 2.1 Equipment

[0070] In one embodiment, a device is provided that facilitates the placement of a light sensor relative to the used dialysate in a drainage bag. Specifically, the device helps ensure that the light sensor and the drainage bag are positioned relative to each other in a configuration that helps ensure accurate and consistent light readings. In the examples below, it is assumed that the light sensor is part of a dialysate analysis device (e.g., a smartphone or tablet). In other examples (not shown), the light sensor may be physically separate from the dialysate analysis device, and the reference to "device" or "dialysis fluid analysis device" below may refer only to the light sensor.

[0071] Figure 2A This is a perspective view of an example of a device 200 according to one embodiment. In this example, device 200 includes a bag tray 202 configured to receive at least a portion of a dialysis drainage bag (not shown). Embodiments that facilitate the positioning of a light sensor relative to the drainage bag can be used in any dialysis situation where used dialysis fluid is drained into the bag rather than discharged into a sink or other location. The bag tray 202 helps ensure consistent positioning of the drainage bag during analysis of the used dialysis fluid. The device placement area 206 is defined by one or more surfaces of device 200 that indicate the intended positioning of the dialysis fluid analysis device (in this example, three surfaces defining a rectangular area). For example, as... Figure 2A As shown, the device placement area 206 helps ensure that the dialysate analyzer is placed below the corner of the drainage bag. Furthermore, the device placement area 206 helps ensure the dialysate analyzer is consistently positioned relative to the light source. For example, as... Figure 2AAs shown, the device placement area 206 helps ensure that the dialysate analysis device is located below the lamp compartment 204, which houses one or more light sources, as further detailed below. The size of the device placement area 206 allows it to accommodate a specific type of dialysate analysis device (e.g., specialized medical equipment). Alternatively, the size of the device placement area 206 allows it to accommodate multiple types of dialysate analysis devices (e.g., smartphones and / or tablets, whose sizes may vary depending on brand and model).

[0072] Figure 2B According to one embodiment, it is without a lamp compartment. Figure 2A A top view of device 200. Specifically, Figure 2B The placement of the dialysis fluid drainage bag 208 on the bag tray 202 is shown. Furthermore, Figure 2B The placement of the dialysate analyzer 210 (in this example, a smartphone with a light-sensing camera) is shown. In this example, the device placement area 206 helps ensure that the dialysate analyzer 210 is positioned below the corner of the dialysate drainage bag 208. Figure 2B An example of a device placement area 206 large enough to accommodate multiple types of devices is also shown.

[0073] Figure 2C According to one embodiment, a lamp housing 204 is attached. Figure 2A A top view of device 200. (See image below.) Figure 2C As shown, lamp housing 204 is positioned above dialysate analysis apparatus 210, such that one or more light sources housed in lamp housing 204 emit light toward or approximately toward the photosensor in dialysate analysis apparatus 210. Lamp housing 204 may be a non-removable part of apparatus 200. Alternatively, lamp housing 204 may be removed from apparatus 200. For example, Figure 2D It is used for Figure 2A A perspective view of an example of a lamp compartment 204 of device 200, the lamp compartment 204 including an attachment interface 214 for attaching the lamp compartment 204 to a bag tray 202. The lamp compartment 204 includes a cavity 212 configured to accommodate electrical components, including but not limited to a light source. Figure 2E According to one embodiment, it is used for Figure 2D A perspective view of an example of the cover 216 of the lamp housing 204. In this example, the cover 216 is removable to provide access to electrical components housed in the lamp housing 204 (e.g., replacing LEDs and / or repairing other electrical components).

[0074] Figure 2F According to one embodiment Figure 2D A top view of lamp holder 204. Specifically, Figure 2FThis is a top view of the lamp compartment 204 after the cover 216 has been removed and no electrical components have been installed. (See image.) Figure 2F As shown, the lamp housing 204 includes one or more light apertures 218 through which one or more light sources emit light. In this example, the lamp housing 204 includes three light apertures 218. The light apertures 218 can be designed to accommodate light sources emitting light of different wavelengths (e.g., lasers and / or LEDs). For example, one light aperture 218 can accommodate a light source emitting light at a wavelength of approximately 1300 nanometers; another light aperture 218 can accommodate a light source emitting light at a wavelength of approximately 810 nanometers; and yet another light aperture 218 can accommodate a light source emitting light at a wavelength of approximately 660 nanometers. In other examples (not shown), more or fewer light sources can be used. One or more light apertures 218 can be located within the cavity 212, such that one or more electrical components, after installation, cover one or more of the light apertures 218.

[0075] Figure 2G According to one embodiment Figure 2D A top view of the electrical component layout of the lamp holder 204. In this example, the electrical components are powered by a power source 220 (e.g., a battery and / or an external power source, such as an AC adapter or USB cable). Figure 2G In the example shown, a 9-volt battery is used. In another example, the electrical components may include a rechargeable battery, allowing device 200 to be disconnected from an external power source when the rechargeable battery is fully charged. Circuit board 222 implements the logic in hardware and / or software to control the operation of the electronic components. Wireless module 224 (e.g.) (And / or a Wi-Fi module) is configured to communicate with the dialysate analyzer 210 to send and receive data. In this example, there are three light sources 226, one of which is blocked by the wireless module 224.

[0076] Figure 2H According to one embodiment Figure 2A Another perspective view of the device. (e.g.) Figure 2H As shown, the attachment interface 226 is configured to receive the light chamber 204, for example, via a connection to... Figure 2D The attached interface 214 of the lamp housing 204 shown is connected to receive the light.

[0077] In one embodiment, device 200 includes a scale configured to weigh dialysate drainage bag 208. For ease of discussion, the terms “weighing” and “weight” as used herein may refer to measuring the mass or weight of dialysate drainage bag 208, as these terms are defined in the art. For example, Figure 2I According to one embodiment Figure 2A A bottom view of device 200. (Example) Figure 2IAs shown, one or more force sensors 228 are arranged in or along the bag tray 202. The force sensors 228 are configured to sense the weight of the dialysate drainage bags 208. The force sensors 228 can be tare beforehand based on the known weight of the device 200 and / or empty dialysate drainage bags 208. Alternatively, tareing and / or other calibration of the force sensors 228 may be necessary when analyzing used dialysate. In some forms of peritoneal dialysis, weighing of the drainage bags may be required, and the device 200 can help meet this requirement. Furthermore, the weight of the drainage bags can be used to calibrate turbidity measurements. Specifically, heavier drainage bags can be assumed to be fuller and therefore physically deeper, while lighter drainage bags are assumed to be emptyer and therefore physically shallower. Turbidity calculations can be adjusted to account for the assumed depth of the drainage bags, which can be based, for example, on average depth measurements taken in a laboratory setting and integrated into the programming of the dialysate analysis device.

[0078] Figure 3A This is a perspective view of another example of the device 300 according to one embodiment. In this example, the device 300 does not include a lamp compartment, and the bag placement area 302 does not include a bag tray. The device 300 may be formed of transparent plastic to improve visibility and reduce shadows that could otherwise interfere with ambient light readings. Furthermore, the upper part of the device 300 may be positioned high enough, i.e., with sufficient openings above the drainage bag, to reduce shadows that might otherwise be projected onto the light sensor of the dialysate analyzer.

[0079] picture Figure 2A-2I As in the example, the device placement area 304 is defined by one or more surfaces of the device 300 (in this example, three surfaces defining a rectangular area), which indicate the intended positioning of the dialysate analysis device. Furthermore, the bag placement area 302 helps ensure consistent positioning of the drainage bag during analysis of used dialysate. For example, Figure 3B According to one embodiment Figure 3A A top view of device 300, which helps ensure the consistent positioning of dialysate drainage bag 306 relative to dialysate analysis device 308. Figure 2A-2I Compared to equipment 200, Figures 3A-3B Device 300 has fewer features but is more portable and / or less expensive. In one embodiment, the dialysate analysis device is configured to be compatible with two or more different types of devices, for example, through hardware switches and / or settings in a software application.

[0080] The examples above illustrate devices for ensuring consistent positioning of the dialysate drainage bag relative to the dialysate analysis device. Alternatively, the dialysate drainage bag itself can be designed to provide guidance for positioning the dialysate analysis device. For example, the drainage bag may include one or more lines, scales, and / or other markings indicating the intended location of the dialysate analysis device. The relative transparency of the drainage bag allows the patient or other operator to use the markings to position the dialysate analysis device in a relatively consistent location. According to this disclosure, many different types of devices and / or other guiding features are conceivable to help ensure consistent positioning of the dialysate drainage bag relative to the dialysate analysis device.

[0081] 2.2 Methods

[0082] Figure 4 This is a flowchart illustrating an example of an operation for analyzing used dialysis fluid in a drainage bag, according to one embodiment. Figure 4 One or more operations shown can be modified together, rearranged, or omitted. Therefore, Figure 4 The specific sequence of operations shown should not be construed as limiting the scope of one or more embodiments.

[0083] In one embodiment, a device including a scale for weighing used dialysate (e.g., Figure 2A-2I The exemplary device is used to analyze the used dialysate. The scale may need to be calibrated before use (operation 402). For example, calibrating the scale may include tare to omit the weight of the device and / or empty drainage bags. The scale can be calibrated based on a bag containing clean dialysate, comparing the weight of that bag to the weight of a drainage bag containing used dialysate.

[0084] In one embodiment, the dialysate analysis device is aligned with the equipment (operation 404). Specifically, the dialysate analysis device can be placed in a specific location indicated by the physical construction of the equipment (e.g., Figure 2A-2I The device placement area 206 of the exemplary device 200 shown, or Figures 3A-3B The device placement area 304 of the device 300 shown. Furthermore, audible and / or visual cues provided by the device and / or the dialysate analysis device can assist in aligning the dialysate analysis device with the device. For example, the dialysate analysis device can provide audible and / or visual cues based on data from a proximity sensor and / or gyroscope to assist patients or other operators in aligning the dialysate analysis device with the device. The audible and / or visual cues can be presented in a graphical user interface, such as... Figures 5A-5D The example graphical user interface shown is shown.

[0085] In one embodiment, the dialysate analysis device is calibrated (operation 406). Calibration of the dialysate analysis device may involve acquiring one or more optical readings using a light sensor when a drainage bag containing used dialysate is not present. Therefore, calibrating the dialysate analysis device can provide a reference optical reading for comparison with optical readings acquired when a drainage bag containing used dialysate is present. For example, the reference may be based on a historical average of the readings. Alternatively, the reference may be based on data (e.g., an average or median) of readings acquired from multiple non-peritoneal drainage bags in a laboratory setting and / or practice.

[0086] In one embodiment, the drainage bag containing used dialysate is aligned with the device (operation 408). Specifically, the drainage bag can be placed in a specific location indicated by the physical construction of the device (e.g., Figure 2A-2I The bag tray 202 of the exemplary device 200 shown, or Figures 3A-3B The device 300 shown has a bag placement area 302. Furthermore, audible and / or visual cues provided by the device and / or the dialysate analysis unit can assist in aligning the drainage bag with the device. For example, the dialysate analysis unit can be based on data from a scale (e.g., as shown in the diagram). Figure 2I Data from one or more force-sensitive resistors (228) shown provides audible and / or visual cues to assist the patient or other operator in aligning the drainage bag with the device. The audible and / or visual cues can be presented in a graphical user interface, such as... Figures 5A-5D The example graphical user interface shown is shown.

[0087] In one embodiment, light is emitted through the drainage bag (operation 410). The light emitted through the drainage bag can be ambient light from the environment (e.g., sunlight and / or one or more general-purpose lamps). Alternatively, a dedicated light source can emit light through the drainage bag (e.g., as shown in the image). Figure 2G The device 200 shown has one or more light sources 226. As described above, the dedicated light source can emit light in response to an electrical signal or other type of instruction sent by the dialysate analysis device.

[0088] In one embodiment, a light sensor senses light emitted through the drainage bag (operation 412). Specifically, the light sensor senses light emitted at one or more specific wavelengths of interest for analyzing used dialysate. As described above, the light sensor can sense light in response to an electrical signal or other type of instruction sent by the dialysate analysis device. The light sensor can sense light in a single read. Alternatively, the light sensor can read multiple readings. When evaluating the data received from the light sensor as described below, the dialysate analysis device can determine an average, median, or other statistical data based on the multiple readings. Furthermore, the dialysate analysis device can discard outliers that significantly deviate from the average, median, or other reference values. The light sensor can output a light reading (e.g., relative luminosity).

[0089] In one embodiment, the dialysate analysis device evaluates data received from a light sensor and / or one or more other sources (operation 414). The dialysate analysis device can evaluate many different types of data to determine various properties (or suspected / predicted properties) of the used dialysate. For example:

[0090] - Dialysis fluid analysis devices can measure the turbidity (i.e., loss of transparency) in used dialysate based on relative luminescence or changes in relative luminescence. Turbidity or relative luminescence can be correlated with white blood cell concentration. For example, Figure 11 A graph illustrating the correlation between relative luminescence and leukocyte concentration is shown. The decrease in transmittance through used dialysate relative to transmittance in unused dialysate (e.g., transmittance through clean air, water, or clean dialysate) can be correlated with leukocyte concentration. Therefore, a decrease in transmittance through used dialysate may indicate an increase in leukocytes. The technique described herein for measuring turbidity may be more objective and sensitive than traditional subjective techniques used to assess “turbidity.” Therefore, the technique described herein can detect clinically significant levels of turbidity at an earlier stage than traditional subjective methods. For example, the International Peritoneal Dialysis Society (IPSD) recommends that peritonitis be diagnosed when at least two of the following symptoms are present: (1) clinical features consistent with peritonitis (e.g., abdominal pain and / or cloudy dialysis effluent); (2) a white blood cell count in the dialysis effluent >100 / µL, with polymorphonuclear leukocytes >50%, after a stay of at least 2 hours; and (3) a positive dialysis effluent culture. In contrast, such as Figure 11 As shown, one or more embodiments can use the optical sensor described herein to detect white blood cell concentrations far below 100 / µL.

[0091] - Dialysis fluid analysis devices can use light scattering data to measure particle size and differentiate white blood cell types. Specifically, the light source can be a laser, and the light sensor can sense the scattering of the laser light through the used dialysate. The characteristics of the scattering can indicate particle size and / or be used to classify white blood cells. This method may require a dark environment to improve the light sensor's ability to detect scattering. Certain types of white blood cells and / or their ratios may indicate a higher likelihood of peritonitis. For example, if approximately half of the white blood cells in the used dialysate are granulocytes, then that ratio could be a strong indicator of peritonitis.

[0092] - The dialysate analyzer can use data from a camera (such as a camera in a smartphone or tablet) to evaluate lateral flow tests or dry chemistry strips. Specifically, based on the appearance of the strip captured by the camera, the dialysate analyzer can measure leukocyte esterase as a substitute for leukocyte concentration.

[0093] Gram staining solutions may have been mixed with used dialysate. Dialysis fluid analysis devices can use data from a microscope to examine used dialysate to identify stained bacteria.

[0094] - A dialysate analysis device can measure the glucose concentration in dialysate. Specifically, a light source can emit near-infrared light, which can be used to detect the glucose concentration in the dialysate. The glucose concentration can be used, for example, for pre- and post-treatment calibration. Specifically, the glucose (dextrose) concentration in fresh dialysate is known (e.g., 1.5%, 2.5%, 4.25%, or other known concentrations). The near-infrared signal of a known glucose concentration can be predetermined, for example, in a laboratory setting. The patient's dialysate prescription can be obtained through manual user input, by loading data from an electronic medical record, or from other sources. For example, the dialysate analysis device can analyze a photograph of a fresh dialysate bag label taken by a smartphone camera or other type of camera (e.g., performing text analysis, reading a barcode, reading a QR code, and / or performing other analyses, or a combination of these operations) to obtain information about the patient's dialysate prescription from the label. Therefore, the near-infrared signal of glucose in the patient's fresh dialysate is known before dialysis. The dialysate analysis device can obtain the near-infrared signal of glucose in used dialysate after dialysis. In one embodiment, changes in glucose levels in the dialysate and blood glucose levels obtained via a glucometer can help estimate peritoneal transport status. Since some patients have higher ultrafiltration volumes than others, turbidity can be normalized to the amount of dialysate used.

[0095] - The dialysate analysis device can evaluate a combination of data received from multiple sources. For example, if turbidity data indicates a white blood cell count greater than 100 / µL, and light scattering data and / or lateral flow analysis or dry chemistry strip data indicate that more than half of the white blood cells are polymorphonuclear cells, the combination of data may indicate peritonitis.

[0096] In one embodiment, the dialysate analysis device determines whether an alarm criterion is met (operation 416). An alarm criterion is a rule that, when met, indicates a condition that may require or benefit from human attention. For example, based on an assessment of one or more types of data as described above, an alarm criterion may indicate an increased risk or likelihood of a patient developing peritonitis. This increased risk or likelihood may be based on absolute values ​​(e.g., turbidity above a threshold amount, or a threshold ratio of granulocytes), trends (e.g., turbidity above a threshold ratio, or the ratio of a specific type of white blood cell), and / or other types of scales, or combinations thereof.

[0097] In one embodiment, the alarm criteria are a composite rule that integrates one or more factors (e.g., turbidity, particle size, ratio of particle types, leukocyte esterase, presence of bacteria and / or other factors, or combinations thereof) to calculate the risk or likelihood of a patient having peritonitis and / or other conditions. For example, additional factors may include: social / environmental factors such as smoking, residence at a distance from the peritoneal dialysis unit, and / or pets; medical factors such as obesity, depression, hypokalemia, hypoalbuminemia, lack of vitamin D supplementation, and / or invasive interventions (e.g., colonoscopy); dialysis-related factors such as prior hemodialysis, peritoneal dialysis against the patient's choice, training, bioincompatible fluids, and / or wet contamination; infection-related factors such as nasal Staphylococcus aureus carriage and / or previous exit site infection; and / or other factors; or combinations thereof. Further factors may include, for example, whether the patient has stopped peritoneal dialysis for a day, whether the used dialysis fluid came from the first drain of a dry day in an APD patient, and / or the duration of the stay. In some cases, one or more factors may indicate that the turbidity is caused by peritoneal fragments, and may suggest flushing rather than taking any measures to treat the infection.

[0098] In one embodiment, the risk or likelihood of a patient's specific condition can be calculated as a numerical score and compared to a threshold value. If alarm criteria are met, the dialysate analysis device generates an alarm (operation 418). This alarm may include a risk score, diagnosis, recommended course of action (e.g., antibiotic treatment or flushing), and / or other information related to peritoneal dialysis and / or other health problems. In some cases, recommended treatment may be advised by self-reported symptoms (e.g., symptoms collected via a graphical user interface as described below). If a test result is positive for a medical condition (e.g., peritonitis) and the self-reported symptoms are also positive for that condition, appropriate treatment (e.g., antibiotics) may be recommended. If a test result is negative and the symptoms are also negative, treatment is not recommended. If the test result and symptoms are inconsistent (i.e., one is positive for a condition and the other is negative), a clinical evaluation may be recommended. Generating alarms can help ensure early detection and treatment of peritonitis and / or one or more other conditions related to peritoneal dialysis. In some cases, generating an alarm can prompt the application of other techniques to confirm the validity of the alarm, such as by sending the dialysis drainage bag and / or some or all of the used dialysis fluid to the laboratory for further analysis.

[0099] 2.3 User Interface

[0100] In one embodiment, the dialysate analysis device includes a user interface (e.g., referred to above). Figure 1A The user interface 111 described herein provides audio and / or visual prompts to assist in analyzing used dialysate in the drainage bag. This user interface may present audio and / or visual prompts to assist in aligning the dialysate analyzer, aligning the drainage bag, calibrating the dialysate analyzer, tare the drainage bag, and / or perform one or more of the operations described herein. Furthermore, the user interface may present alarms based on alarm criteria.

[0101] Figures 5A-5D These are illustrations of an example of a graphical user interface according to one embodiment. These illustrations are for illustrative purposes only and should not be construed as limiting one or more embodiments. In this example, the graphical user interface is generated by a software application running on a smartphone.

[0102] Figure 5A An example of a graphical user interface (GUI) is shown, which presents prompts to help align the dialysate analyzer. In this example, the prompts include visual instructions to place the dialysate analyzer on a flat surface. Figure 5BAn example of a graphical user interface (GUI) is shown, which presents prompts to help calibrate a dialysate analyzer. In this example, the prompts include a visual instruction to leave the dialysate analyzer to avoid casting shadows when the analyzer acquires reference light readings. Figure 5C An example of a graphical user interface (GUI) is shown, which presents prompts to help align the drainage bag. In this example, the prompts include visual guidance indicating the placement of the drainage bag (i.e., above the area of ​​the dialysate analyzer including the light sensor). Furthermore, the prompts indicate, for example, whether the drainage bag has been detected in the correct position based on readings from a scale and / or the light sensor. Figure 5D An example of a graphical user interface is shown, which presents data collected and / or calculated when analyzing used dialysate in a drainage bag. In this example, the data includes measured ambient light illuminance, measured turbidity of the used dialysate, and the difference between two illuminance values.

[0103] In one embodiment, a user interface that provides such prompts helps ensure more accurate dialysate analysis and / or more consistent dialysate analysis over multiple uses, compared to not providing audible and / or visual prompts to patients or other operators.

[0104] 3. Analyze the used dialysis fluid in the drainage tube.

[0105] In one embodiment, a device is provided to facilitate the placement of a light sensor (e.g., in the transparent section of the drainage tube or in a light-transmitting chamber arranged along the drainage tube) relative to the used dialysate. Specifically, the device helps ensure that the light sensor is positioned relative to the transparent section of the drainage tube, the drainage tube observation chamber, or the light-transmitting chamber in a configuration that helps ensure accurate and consistent light readings. In the examples below, it is assumed that the light sensor is part of a device separate from the dialysate analysis apparatus. In other examples (not shown), the light sensor may be part of the dialysate analysis apparatus.

[0106] 3.1 Equipment

[0107] Figure 6AThis is a schematic diagram of an example of a light-transmitting chamber 602 according to one embodiment. The light-transmitting chamber 602 can be mounted along a drainage tube using a drainage tube attachment point 604. The drainage tube attachment point 604 is configured to attach to a corresponding attachment point (not shown) within the drainage tube itself. Conventional drainage tubes do not include such attachment points. Therefore, using the light-transmitting chamber 602 may require a non-conventional drainage tube configured to accommodate the light-transmitting chamber 602. To calibrate a photosensing device used with the light-transmitting chamber 602, the photosensing device can first be secured (e.g., clamped) to a calibration chamber or other light-transmitting component (not shown), which may, for example, be made of multilayer plastic or glass with known optical quality. Sensing light transmitted through the calibration chamber allows calibration to a baseline state before analyzing used dialysate using the light-transmitting chamber 602.

[0108] Figure 6B This is a schematic diagram of an example of a light sensing device 605 according to one embodiment. Specifically, Figure 6B The diagram shows a configuration for emitting light and detecting light transmitted through a light-transmitting chamber (e.g., Figure 6A An example of a light sensing device 605 for an exemplary light-transmitting chamber 602 is shown. The light sensing device 605 includes a light source 606 and a light sensor 608 disposed on opposite sides of a clamping mechanism (e.g., a clamp). The clamping mechanism is configured such that when the light sensing device 605 is clamped onto the light-transmitting chamber, light emitted by the light source 606 is directed or approximately directed to the light sensor 608. The light source 606 may be configured to emit light of a single wavelength or multiple wavelengths. The light sensor 608 may be configured to sense light of a single wavelength or multiple wavelengths. The light sensing device 605 is configured to transmit data from the light sensor 608 to a dialysate analysis apparatus via a communication interface 610, which in this example is a USB cable.

[0109] In one embodiment, the light-transmitting chamber 602 and / or the light-sensing device 605 are constructed in a manner similar to a device used to measure blood properties such as hematocrit, change in blood volume percentage, and / or oxygen saturation. For example, the light-transmitting chamber 602 may be constructed in a manner similar to the Crit-Line blood chamber manufactured by Fresenius Medical Care, which is typically used with the Crit-Line III monitor, also manufactured by Fresenius Medical Care. The light-transmitting chamber 602 may include structural modifications to the blood chamber construction, such as allowing the light-transmitting chamber 602 to be arranged along a drainage tube. The light-sensing device 605 may be a CLIC manufactured by Fresenius Medical Care. TM The device is designed to clamp onto the Crit-Line blood chamber. The Crit-Line blood chamber and CLiC... TMThe devices are designed to be compatible with each other. Specifically, the Crit-Line blood chamber has a flat outer surface that allows the CLIC to be inserted. TM The light source 606 and the light sensor 608 of the device are housed in a generally parallel and opposite position, such that light from the light source 606 passes through the blood chamber to the light sensor 608. Modifying and / or reusing existing devices commonly used for blood analysis can save costs for the company manufacturing the device, while extending the device's utility to the unconventional dialysate analysis techniques described herein.

[0110] In one embodiment, the light-transmitting chamber 602 is a removable and disposable single-use or multiple-use chamber. Alternatively, the light-transmitting chamber 602 may be attached to a drainage tube and / or designed for multiple uses before disposal.

[0111] Although referenced in the above text Figures 6A-6B Some examples have been described, but the light sensing device can also take other forms. For example, the light sensing device may include a housing (e.g., a cubic housing) configured to be attached to or otherwise arranged along a drainage tube (e.g., above a drainage tube observation chamber, a light-transmitting chamber, or a transparent section of the drainage tube). One or more light sources and one or more light sensors may be arranged within the housing. The housing helps to avoid light pollution from light sources other than those contained within the housing.

[0112] 3.2 Methods

[0113] Figure 7 This is a flowchart illustrating an example of an operation for analyzing used dialysis fluid in a drainage tube, according to one embodiment. Figure 7 One or more operations shown can be modified together, rearranged, or omitted. Therefore, Figure 7 The specific sequence of operations shown should not be construed as limiting the scope of one or more embodiments.

[0114] In one embodiment, a light sensing device (e.g.) Figure 6B The exemplary photosensing device 605 shown is arranged along the drainage tube. The photosensing device can be arranged, for example, in the transparent section or light-transmitting chamber of the drainage tube (e.g., Figure 6A The exemplary light-transmitting chamber 602 shown. The light-sensing device is arranged such that when light is emitted through the used dialysate drained through the drainage tube (emitted by a light source that is part of the light-sensing device or from another light source), the light sensor in the light-sensing device can sense the emitted light.

[0115] In one embodiment, light is emitted through the used dialysate (operation 704). Specifically, the light is emitted through the transparent section of the drainage tube where the light sensing device is located, the observation chamber of the drainage tube, or the light-transmitting chamber. The light emitted through the used dialysate can be ambient light from the environment (e.g., sunlight and / or one or more general-purpose lamps). Alternatively, a dedicated light source can emit light through the used dialysate (e.g., as shown in the image). Figure 6B The light sensing device 605 shown may include one or more light sources 606. As described above, the dedicated light source may emit light in response to an electrical signal or other type of instruction sent by the dialysate analysis device.

[0116] In one embodiment, a light sensor in the light sensing device senses light emitted through the used dialysate (operation 706). Specifically, the light sensor senses light emitted at one or more specific wavelengths for analyzing the used dialysate. As described above, the light sensor can sense light in response to an electrical signal or other type of instruction sent by the dialysate analysis device. The light sensor can sense light in a single read. Alternatively, the light sensor can read multiple readings. When evaluating the data received from the light sensor as described below, the dialysate analysis device can determine an average, median, or other statistical data based on the multiple readings. Furthermore, the dialysate analysis device can discard outliers that significantly deviate from the average, median, or other benchmark values.

[0117] In one embodiment, the dialysate analyzer evaluates data received from a light sensor and / or one or more other sources (operation 708). The dialysate analyzer may determine whether alarm criteria are met (operation 710). If the alarm criteria are met, the dialysate analyzer may generate an alarm (operation 712). Evaluating data, determining whether alarm criteria are met, and generating an alarm can be referenced as described above. Figure 4 The process will be carried out on the site described.

[0118] 4. User interface for patient tracking

[0119] In one embodiment, the dialysate analysis device includes hardware and / or software for tracking a patient's medical history, which may include a history of measurements and / or calculations of any type described herein. The medical history may also include self-reported data such as symptoms, urine output, etc. The patient's medical history can be uploaded and saved to the patient's electronic health record. The dialysate analysis device can be configured to use a user interface (e.g., as referred to above) Figure 1A The user interface 111 presents information about patient tracking. Alternatively, the dialysate analyzer may be configured to present a user interface to receive user input that may aid in patient tracking and / or diagnosis. Figures 8A-8EThese are schematic diagrams illustrating one example of a graphical user interface for patient tracking according to one embodiment. These illustrations are for illustrative purposes only and should not be construed as limiting one or more embodiments. In this example, the graphical user interface is generated by a software application running on a smartphone.

[0120] Figure 8A An example of a graphical user interface presenting a patient's risk score quantifies the patient's risk or likelihood of peritonitis is shown. The risk score can be calculated as described above. In this example, the risk score is a numerical value. Figure 8B An example of a graphical user interface (GUI) is shown, which presents user interface controls that allow patients to indicate any symptoms they may be experiencing (e.g., peritonitis-related symptoms). The dialysis fluid analysis device can store a history of these symptoms. Alternatively, certain symptoms may trigger alerts indicating a risk of peritonitis. As described above, symptoms can be compared with test results to determine recommended course of action (e.g., treatment or clinical follow-up). Figure 8C An example of a graphical user interface showing the history of turbidity in used dialysis fluid is illustrated. This history can help patients or other operators identify trends indicating improvement or deterioration in their health. For instance, if the drainage bag does not become clean within a threshold timeframe following treatment (e.g., 5 days after starting antibiotic therapy), further clinical attention may be required. As another example, a trend of decreasing white blood cell counts may indicate successful treatment. If the trend is not as expected (e.g., white blood cells do not decrease as rapidly as anticipated), treatment can be adjusted while it continues (e.g., by adjusting the type and / or dosage of antibiotics). Similarly, Figure 8D An example of a graphical user interface (GUI) presenting user interface controls and trends is shown, which allows the patient to input the weight of the excretion and the amount of urine. Figure 8E An example of a graphical user interface presenting a gamified interface is shown, where patients or other human operators earn "points" (in this case, stars) as rewards for completing certain challenges and / or goals. For example, stars are earned each time a dialysis fluid analyzer is used to analyze used dialysis fluid, helping to encourage continuous health monitoring. Figure 8E As shown, gamification features can include social components where users are compared to one or more friends / contacts participating in the same challenges and / or goals. Generally, gamification may be associated with improved treatment adherence.

[0121] 5. Others; Extensions

[0122] In one embodiment, the system includes one or more means configured to perform any of the operations described herein and / or recited in any of the claims, including one or more hardware processors.

[0123] In one embodiment, a non-transitory computer-readable storage medium stores instructions that, when executed by one or more hardware processors, cause the execution of any operation described herein and / or recited in any of the claims.

[0124] According to one embodiment, any combination of the features and functions described herein may be used. In the foregoing description, embodiments have been described with reference to numerous specific details, which may vary depending on the specific implementation. Therefore, the description and drawings should be considered exemplary rather than limiting. The scope of the invention, and the scope of the invention as desired by the applicant, is defined only by the written scope and equivalents of the claims arising from this application in the specific form that produces the claims (including any subsequent amendments).

[0125] 6. Computing equipment

[0126] In one embodiment, the techniques described herein are implemented by one or more dedicated computing devices (i.e., computing devices specifically configured to perform particular functions). The dedicated computing devices may be hardwired to execute these techniques and / or may include digital electronic devices, such as one or more application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), and / or network processing units (NPUs) permanently programmed to execute these techniques. Alternatively, the computing device may include one or more general-purpose hardware processors programmed to execute these techniques according to program instructions in firmware, memory, and / or other storage devices. Alternatively, the dedicated computing device may combine custom hardwired logic, ASICs, FPGAs, or NPUs with custom programming to implement these techniques. Dedicated computing devices may include desktop computer systems, portable computer systems, handheld devices, network devices, and / or any other devices that combine hardwired and / or program logic to implement the techniques.

[0127] For example, Figure 9 This is a block diagram of an example of a computer system 900 according to one embodiment. The computer system 900 includes a bus 902 or other communication mechanism for transmitting information, and a hardware processor 904 coupled to the bus 902 for processing information. The hardware processor 904 may be a general-purpose microprocessor.

[0128] Computer system 900 also includes main memory 902, such as random access memory (RAM) or other dynamic storage device, coupled to bus 902, for storing information and instructions to be executed by processor 904. Main memory 906 can also be used to store temporary variables or other intermediate information during instruction execution by processor 904. Such instructions, when stored in one or more non-transitory storage media accessible by processor 904, transform computer system 900 into a dedicated machine customized to perform the operations specified in the instructions.

[0129] The computer system 900 also includes a read-only memory (ROM) 908 or other static storage device coupled to a bus 902, which is used to store static information and instructions for the processor 904. Storage devices 910, such as magnetic disks or optical disks, are provided and coupled to the bus 902 for storing information and instructions.

[0130] Computer system 900 can be coupled to display 912 via bus 902, such as a liquid crystal display (LCD), plasma display, electronic ink display, cathode ray tube (CRT) monitor, or any other type of device for displaying information to a computer user. Input device 914, including alphanumeric keys and other keys, can be coupled to bus 902 for transmitting information and command selections to processor 904. Alternatively, computer system 900 can receive user input via cursor control device 916, such as a mouse, trackball, trackpad, or cursor arrow keys, for transmitting directional information and command selections to processor 904 and for controlling cursor movement on display 912. This input device typically has two degrees of freedom on two axes (a first axis (e.g., x) and a second axis (e.g., y)), allowing the device to specify a position in a plane. Alternatively, computer system 900 can include a touchscreen. Display 912 can be configured to receive user input via one or more pressure-sensitive sensors, multi-touch sensors, and / or gesture sensors. Alternatively, the computer system 900 may receive user input via a microphone, camera, and / or some other type of user input device (not shown).

[0131] Computer system 900 may implement the techniques described herein using custom hardwired logic, one or more ASICs or FPGAs, firmware, and / or program logic. This logic, combined with other components of computer system 900, enables computer system 900 to become a special-purpose machine, or to program computer system 900 as a special-purpose machine. According to one embodiment, computer system 900 executes the techniques described herein in response to processor 904 executing one or more sequences of one or more instructions contained in main memory 906. Such instructions may be read into main memory 906 from another storage medium (e.g., storage device 910). Execution of the sequence of instructions contained in main memory 906 causes processor 904 to perform the processing steps described herein. Alternatively or additionally, hardwired circuitry may be used in place of or in combination with software instructions.

[0132] As used herein, the term "storage medium" refers to one or more non-transitory media that store data and / or instructions that enable a machine to operate in a particular manner. Such storage media may include non-volatile media and / or volatile media. Non-volatile media include, for example, optical discs or magnetic disks, such as storage device 910. Volatile media include dynamic memory, such as main memory 906. Common forms of storage media include, for example, floppy disks, hard disks, solid-state drives, magnetic tapes or any other magnetic data storage media, CD-ROMs or any other optical data storage media, any physical media with a hole arrangement pattern, RAM, programmable read-only memory (PROM), erasable PROM (EPROM), FLASH-EPROM, non-volatile random access memory (NVRAM), any other memory chip or memory cartridge, content-addressable memory (CAM), and tri-state content-addressable memory (TCAM).

[0133] Storage media differ from transmission media, but can be used in conjunction with them. Transmission media participate in the information transfer between storage media. Examples of transmission media include coaxial cables, copper wires, and optical fibers, including wiring containing a bus 902. Transmission media can also take the form of sound waves or light waves, such as those generated during radio wave and infrared data communication.

[0134] Various forms of media may be involved when transferring one or more sequences of one or more instructions to processor 904 for execution. For example, the instructions may initially be carried on a disk or solid-state drive of a remote computer. The remote computer may load the instructions into its dynamic memory and send them over a network via a network interface controller (NIC) such as an Ethernet controller or a Wi-Fi controller. The native NIC of computer system 900 may receive data from the network and place the data on bus 902. Bus 902 transfers the data to main memory 906, from which processor 904 fetches and executes the instructions. Instructions received by main memory 906 may be stored on storage device 904 as needed, before or after execution by processor 910.

[0135] Computer system 900 also includes a communication interface 918 coupled to bus 902. Communication interface 918 provides bidirectional data communication coupled to network link 920, which connects to local network 922. For example, communication interface 918 may be an Integrated Services Digital Network (ISDN) network card, a wired modem, a satellite modem, or a modem to provide data communication connectivity to a corresponding type of telephone line. As another example, communication interface 918 may be a Local Area Network (LAN) card to provide data communication connectivity to a compatible LAN. Wireless links may also be implemented. In any such implementation, communication interface 918 transmits and receives electrical, electromagnetic, or optical signals carrying digital data streams representing various types of information.

[0136] Network link 920 typically provides data communication to other data devices via one or more networks. For example, network link 920 may provide a connection to host computer 924 or data devices operated by Internet Service Provider (ISP) 926 via local network 922. ISP 926, in turn, provides data communication services via a global packet data communication network (now commonly referred to as the "Internet" 928). Both local network 922 and Internet 928 use electrical, electromagnetic, or optical signals carrying digital data streams. Signals through various networks, signals on network link 920, and signals through communication interface 918 are exemplary forms of transmission media carrying digital data to and from computer system 900.

[0137] Computer system 900 can send messages and receive data, including program code, via a network, network link 920, and communication interface 918. In the example of the Internet, server 930 can transmit application request codes via the Internet 928, ISP 926, local network 922, and communication interface 918.

[0138] The received code can be executed by processor 904 when it is received, and / or stored in storage device 910 or other non-volatile memory for later execution.

[0139] 7. Computer Networks

[0140] In one embodiment, a computer network provides connectivity between a set of nodes running software utilizing the techniques described herein. These nodes may be local and / or remote relative to each other. The nodes are connected by a set of links. Examples of links include coaxial cable, unshielded twisted pair, copper cable, fiber optic cable, and virtual links.

[0141] A subset of nodes implements a computer network. Examples of such nodes include switches, routers, firewalls, and Network Address Translation (NAT). Another subset of nodes uses the computer network. Such nodes (also called "hosts") can execute client processes and / or server processes. Client processes request computing services (e.g., requesting the execution of a specific application and / or the retrieval of a specific dataset). Server processes respond by performing the requested services and / or returning the corresponding data.

[0142] A computer network can be a physical network, including physical nodes connected by physical links. A physical node is any digital device. A physical node can be a functionally specific hardware device. Examples of functionally specific hardware devices include hardware switches, hardware routers, hardware firewalls, and hardware NAT. Alternatively, a physical node can be any physical resource that provides computing power to perform tasks, such as a physical resource configured to run various virtual machines and / or applications performing corresponding functions. A physical link is the physical medium connecting two or more physical nodes. Examples of links include coaxial cable, unshielded twisted pair, copper cable, and fiber optic cable.

[0143] Computer networks can be overlay networks. An overlay network is a logical network implemented on top of another network (such as a physical network). Each node in the overlay network corresponds to a corresponding node in the underlying network. Therefore, each node in the overlay network is associated with an overlay address (used to address the overlay node) and an underlying address (used to address the underlying node that implements the overlay node). Overlay nodes can be digital devices and / or software processes (such as virtual machines, application instances, or threads). Links connecting overlay nodes can be implemented as tunnels through the underlying network. Overlay nodes at both ends of the tunnel can treat the underlying multi-hop path between them as a single logical link. Tunneling is performed through encapsulation and decapsulation.

[0144] In one embodiment, the client may be local and / or remote to the computer network. The client may access the computer network via other computer networks (e.g., a private network or the Internet). The client may transmit requests to the computer network using communication protocols such as Hypertext Transfer Protocol (HTTP). These requests are communicated through an interface, such as a client interface (e.g., a web browser), a program interface, or an application programming interface (API).

[0145] In one embodiment, a computer network provides connectivity between clients and network resources. Network resources include hardware and / or software configured to execute server processes. Examples of network resources include processors, data storage, virtual machines, containers, and / or software applications. Network resources can be shared among multiple clients. Clients independently request computing services from the computer network. Network resources are dynamically allocated to requesting and / or clients based on demand. The network resources allocated to each requesting and / or client can be increased or decreased, for example, based on (a) the computing services requested by a particular client, (b) the aggregated computing services requested by a particular tenant, and / or (c) the aggregated computing services requested by the computer network. Such a computer network may be referred to as a "cloud network".

[0146] In one embodiment, a service provider offers a cloud network to one or more end users. The cloud network can implement various service models, including but not limited to Software as a Service (SaaS), Platform as a Service (PaaS), and Infrastructure as a Service (IaaS). In SaaS, the service provider offers end users the ability to use the service provider's applications, which execute on network resources. In PaaS, the service provider offers end users the ability to deploy custom applications on network resources. Custom applications can be created using programming languages, libraries, services, and tools supported by the service provider. In IaaS, the service provider offers end users the ability to configure processing, storage, networking, and other basic computing resources provided by the network resources. Any application, including operating systems, can be deployed on network resources.

[0147] In one embodiment, a computer network can implement various deployment models, including but not limited to private cloud, public cloud, and hybrid cloud. In a private cloud, network resources are provided exclusively to a specific group of one or more entities (the term "entity" as used herein refers to a company, organization, individual, or other entity). The facilities for the network resources relative to the specific group of entities can be local and / or remote. In a public cloud, cloud resources are provisioned for multiple independent entities (also referred to as "tenants" or "customers"). In a hybrid cloud, the computer network includes both private and public clouds. The interface between the private and public clouds allows for the portability of data and applications. Data stored in the private cloud and data stored in the public cloud can be exchanged through this interface. Applications implemented in the private cloud and applications implemented in the public cloud may depend on each other. Calls from applications in the private cloud to applications in the public cloud (or vice versa) can be performed through this interface.

[0148] In one embodiment, the system supports multiple tenants. A tenant is a company, organization, enterprise, business unit, employee, or other entity that accesses shared computing resources (e.g., shared computing resources in a public cloud). One tenant can be distinguished from another (by business, tenant-specific practices, employees, and / or externally oriented identifiers). Clients corresponding to different tenants access the computer network and its network resources. Such a computer network may be referred to as a "multi-tenant computer network." Multiple tenants can use the same specific network resources at different times and / or at the same time. The network resources can be local and / or remote relative to the tenant's facilities. Different tenants may have different network requirements for the computer network. Examples of network requirements include processing speed, data storage capacity, security requirements, performance requirements, throughput requirements, latency requirements, resilience requirements, quality of service (QoS) requirements, tenant isolation, and / or consistency. The same computer network may need to meet the different network needs of different tenants.

[0149] In one embodiment, in a multi-tenant computer network, tenant isolation is implemented to ensure that applications and / or data from different tenants are not shared with each other. Various tenant isolation methods can be used. In one embodiment, each tenant is associated with a tenant identifier (ID). Applications implemented by the computer network are tagged with the tenant's ID. Alternatively, data structures and / or datasets stored by the computer network are tagged with the tenant's ID. A tenant is only allowed access to a specific application, data structure, and / or dataset if the tenant and the specific application, data structure, and / or dataset are associated with that tenant's ID. As an example, each database implemented by a multi-tenant computer network can be tagged with a tenant ID. Only the tenant associated with the corresponding tenant ID can access the data in that specific database. As another example, each data item in a database implemented by a multi-tenant computer network can be tagged with a tenant ID. Only the tenant associated with the corresponding tenant ID can access the data in that specific data item. However, the database can be shared by multiple tenants. Subscription lists can indicate which tenants are authorized to access which applications. For each application, a list of tenant IDs of tenants authorized to access that application is stored. A tenant is only allowed access to that specific application if their tenant ID is included in the subscription list corresponding to that specific application.

[0150] In one embodiment, network resources (e.g., digital devices, virtual machines, application instances, and threads) corresponding to different tenants are isolated to a tenant-specific overlay network maintained by a multi-tenant computer network. For example, packets from any source device in the tenant overlay network may only be sent to other devices in that tenant overlay network. Encapsulation tunneling can be used to prevent any transmission from a source device on one tenant overlay network to devices in other tenant overlay networks. Specifically, packets received from the source device are encapsulated in an outer packet. The outer packet is transmitted from a first encapsulation tunnel endpoint (communicating with the source device in the tenant overlay network) to a second encapsulation tunnel endpoint (communicating with the target device in the tenant overlay network). The second encapsulation tunnel endpoint decapsulates the outer packet to obtain the original packet sent by the source device. The original packet is transmitted from the second encapsulation tunnel endpoint to the target device in the same specific overlay network.

[0151] 8. Connected Health System

[0152] As described herein, systems 100 and 101 may be configured to be part of or communicate with the Connected Health (CH) system 1000. Figure 10This is a schematic diagram illustrating an example of an Interconnected Health (CH) system 1000, which may include a processing system 1005, a CH cloud service 1010, and a gateway (CH gateway) 1020, etc., that can be used in conjunction with the network aspects of the system described herein. The processing system 1005 may be a server- and / or cloud-based system that processes medical information, including prescription information generated at a clinic or hospital's Clinical Information System (CIS) 1004, in conjunction with the data transmission operations of the CH system 1000, including performing compatibility checks and / or formatting on this information. The CH system 1000 may include appropriate encryption and data security mechanisms. The CH cloud service 1010 may be a cloud-based application that acts as a communication conduit (e.g., facilitating data transmission) between components of the CH system 1000 via a connection to a network (e.g., the Internet). The gateway 1020 may be used as a communication device to facilitate communication between components of the CH system 1000. In various embodiments, gateway 1020 can communicate with dialysis machine 1002 (e.g., a PD cycler) and systems 100 / 101 via wireless connection 1001, such as Bluetooth, Wi-Fi, and / or other suitable types of local or short-range wireless connections. Gateway 1020 can also connect to CH cloud service 1010 via a secure network (e.g., the Internet). Gateway 1020 can be configured to send / receive data to / from CH cloud service 1010, and to send / receive data to / from dialysis machine 1002 and systems 100 / 101. Dialysis machine 1002 can poll CH cloud service 1010 for available files (e.g., via gateway 320), and dialysis machine 1002 and / or systems 100 / 101 can temporarily store available files for processing.

Claims

1. An apparatus for analyzing used dialysate, comprising: a bag tray defining at least one first surface configured to accommodate a dialysate drainage bag on top of the first surface; and a device placement area for accommodating a dialysate analysis device, the device placement area being defined by one or more surfaces of the apparatus that indicate an intended positioning of the dialysate analysis device, the device placement area ensuring that the dialysate analysis device is placed under a corner of the drainage bag, such that when the dialysate drainage bag is positioned on top of the first surface and the dialysate analysis device is placed in the device placement area, a light sensor of the dialysate analysis device is positioned under the dialysate drainage bag, the light sensor being configured to sense light passing through the dialysate drainage bag; and a light emitting device positioned above the dialysate analysis device and configured to emit light through the dialysate drainage bag towards the light sensor of the dialysate analysis device, the light emitting device being configured to operate in response to an instruction sent by the dialysate analysis device.

2. The apparatus of claim 1, further comprising a scale configured to measure a weight of the dialysate drainage bag when the dialysate drainage bag is placed on top of the dialysate analysis device.

3. The apparatus of claim 2, wherein the apparatus is further configured to communicate the weight of the dialysate drainage bag to the dialysate analysis device.

4. The apparatus of claim 1, further comprising a wireless device configured to communicate with the dialysate analysis device.

5. The apparatus of claim 1, wherein the dialysate analysis device is a smartphone.

6. The apparatus of claim 1, wherein, the light emitting device is configured to emit light of a first frequency during a calibration of the dialysate analysis device and to emit light of a second frequency during an analysis of dialysate in the dialysate drainage bag by the dialysate analysis device.

7. The apparatus of claim 6, wherein, the first frequency of light is different from the second frequency of light.

8. The apparatus of claim 6, wherein, during the analysis, the light emitting device is configured to emit light of a third frequency, the third frequency of light being different from the second frequency of light.

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