Device for detecting infection from peritoneal dialysis

Abstract

The present disclosure generally relates to a device (200) for detecting an infection in a patient (102) undergoing peritoneal dialysis. The device (200) comprises a housing module (202) removably coupleable to a fluid element (204) configured to receive dialysate effluent (130) from the patient (102), a set of lighting elements (206) disposed on the housing module (202) and configured to emit light into the fluid element (204), a set of optical sensors (208) disposed on the housing module (202) and configured to measure optical properties of the light interacting with the dialysate effluent (130) in the fluid element (204), and a control module configured to measure turbidity of the dialysate effluent (130) based on the optical properties, the dialysate turbidity being indicative of an infection in the patient (102) if the dialysate turbidity and the patient's (102) historical dialysate turbidity satisfy a set of predetermined conditions.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This disclosure claims the benefit of Singapore Patent Application No. 10202083858V, filed April 15, 2021, which is incorporated by reference in its entirety.

[0002] The present disclosure relates generally to a device for detecting infection from peritoneal dialysis. More specifically, the present disclosure describes various embodiments of a device for detecting infection, such as peritonitis, in a patient undergoing peritoneal dialysis. [Background technology]

[0003] Millions of people around the world suffer from kidney-related problems, for example, chronic kidney disease (CKD) and end-stage renal disease (ESRD), and require dialysis or transplants to sustain their lives. There are two types of dialysis: hemodialysis and peritoneal dialysis. In hemodialysis, blood is pumped from the patient's body into a dialyzer, which filters the blood and returns the filtered blood to the body. In peritoneal dialysis, the peritoneum in the patient's abdomen acts as a natural filtering membrane. Dialysis provides a means of survival in cases of kidney failure, but with significant changes in quality of life. Performing dialysis at home rather than in a clinical facility can improve the quality of life of patients by allowing them to schedule dialysis around their own activities, normalizing their daily lives to some extent. However, home dialysis does have its challenges. Patients or their caregivers need to learn how to perform home dialysis themselves, and the operation steps can be very cumbersome, especially in the case of peritoneal dialysis.

[0004] FIG. 1 shows a typical peritoneal dialysis machine 100 used at home by a patient 102. The patient 102 has a transfer set 104 that includes a catheter that is inserted into the patient's abdomen. To begin peritoneal dialysis, the patient 102 connects the transfer set 102 to a common tube or line or patient line 106 that leads to a tube connector 108. The transfer set 104 has a valve 105 for opening and closing the catheter, which must normally be closed to prevent infection. A fresh bag 110 containing fresh dialysate or dialysis solution is connected to the tube connector 108 via a supply tube or fill line 112. The fill line 112 has a valve 114 for opening and closing the fill line 112 at the appropriate stage during peritoneal dialysis. A drain bag 116 is connected to the tube connector 108 via a drain tube or line 118. The drain line 118 has a valve 120 for opening and closing the drain line 118 at the appropriate stage during peritoneal dialysis.

[0005] During peritoneal dialysis, fresh dialysate from the fresh bag 110 flows into the abdomen, and the peritoneum transfers waste and excess fluid from the blood into the fresh dialysate. The fresh dialysate contains sugars, e.g., glucose / dextrose, which act as the main osmotic agent that allows fluid to be removed or filtered through the peritoneum into the peritoneal cavity. The used dialysate is later drained from the body as dialysis waste, which contains waste and excess fluid. The dialysis waste is collected in the drain bag 116 and discarded. The device 100 may be configured to perform fluid exchange by gravity. Alternatively, the device 100 may include a machine or pump 122 to perform the fluid exchange, e.g., while the patient 102 is sleeping.

[0006] The device 100 allows the patient 102 to receive peritoneal dialysis treatment at home or while active without significantly compromising their quality of life. However, the patient 102 must be careful when handling the device 100 to avoid contamination. For example, the patient 102 may not properly connect the transfer set 104 to the common line 106 due to insufficient training or other reasons, risking contamination by touching the tip of the transfer set 104 and / or the common line 106 with their hands. Such contamination may cause the patient 102 to become infected, such as, for example, peritonitis.

[0007] Peritonitis may be detected by visually observing the cloudiness or turbidity of the dialysis effluent in the drain bag 116 as well as observing any symptoms associated with abdominal pain. However, the observation of cloudiness in the dialysis effluent is very subjective, and slight changes in cloudiness may not be easily noticed by the naked eye. Also, different patients 102 may have different acuity in this task. Early peritonitis may cause mild cloudiness that is not noticed by the patient 102, leading to delays in diagnosis and treatment. Thus, the quality of checks is inconsistent among patients 102, some peritonitis cases are missed, and some non-peritonitis cases become false positives. Also, some patients 102 with peritonitis may not show symptoms in the early stages, and symptoms such as mild abdominal pain are erroneously attributed to other factors, leading to delays in diagnosis and treatment. It may take only a few days for cloudiness to become evident and / or symptoms to become severe. But this also means that the peritonitis has progressed to a more advanced stage, which can be difficult to treat and result in a higher mortality rate.

[0008] Therefore, there is a need to provide an improved device for detecting infection from peritoneal dialysis to overcome or mitigate at least one of the problems and / or drawbacks discussed above. Summary of the Invention

[0009] According to a first aspect of the present disclosure, there is a device for detecting infection in a patient undergoing peritoneal dialysis. The device includes: a housing module removably connectable to a fluid element configured to receive dialysis effluent from a patient; a set of lighting elements disposed on the housing module and configured to emit light into the fluidic element; a set of optical sensors disposed on the housing module and configured to measure optical characteristics of light interacted with the dialysis effluent in the fluid element; a control module configured to measure the turbidity of the dialysis effluent based on the optical properties; Equipped with The dialysate turbidity is indicative of an infection in a patient if the dialysate turbidity and the patient's historical dialysate turbidity meet a set of predetermined conditions.

[0010] According to a second aspect of the present disclosure, there is a device for detecting infection in a patient undergoing peritoneal dialysis. The device includes: a housing module removably connectable to a fluid element configured to receive dialysis effluent from a patient; a color sensor configured to measure color information of a reagent test element disposed within the fluidic element that has reacted with the dialysis waste fluid within the fluidic element; a control module configured to detect infection based on color information representative of enzyme activity in the dialysis effluent indicative of infection in a patient; Equipped with.

[0011] According to a third aspect of the present disclosure, there is a device for detecting infection in a patient undergoing peritoneal dialysis. The device includes: a housing module removably connectable to a fluid element configured to receive dialysis effluent from a patient; a set of lighting elements disposed on the housing module and configured to emit light into the fluidic element; disposed on the housing module, Measuring optical properties of light interacting with the dialysis waste fluid in the fluid element; Measure the color information of the reagent test element disposed in the fluid element that reacts with the dialysis waste fluid in the fluid element. a set of optical sensors configured for: and determining a turbidity of the dialysate effluent based on the optical characteristics, the dialysate turbidity being indicative of an infection in the patient if the dialysate turbidity and the patient's past dialysate turbidity meet a set of predetermined conditions; Detecting infection based on color information representing enzyme activity in dialysis wastewater, which indicates infection A control module configured for Equipped with.

[0012] According to a fourth aspect of the present disclosure, there is a computerized method for detecting an infection in a patient undergoing peritoneal dialysis, the method comprising: Measuring the color information of the reagent test element reacted with the dialysis waste fluid from the patient; Extracting RGB color data from the color information; detecting an infection based on RGB color data, the RGB color data representing an enzyme activity in the dialysis effluent indicative of an infection in the patient; Equipped with.

[0013] Thus, disclosed herein is a device for detecting infection from peritoneal dialysis in accordance with the present disclosure. Various features, aspects, and advantages of the present disclosure will become more apparent from the detailed description of embodiments thereof given below, by way of non-limiting examples only, in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a diagram of a peritoneal dialysis device. [Figure 2A] FIG. 1 is a diagram of a device for detecting infection based on the turbidity of dialysis effluent. [Figure 2B] FIG. 1 is a diagram of a device for detecting infection based on the turbidity of dialysis effluent. [Figure 3A] FIG. 2C is a diagram of the device of FIGS. 2A and 2B in use with a peritoneal dialysis machine. [Figure 3B] FIG. 2C is a diagram of the device of FIGS. 2A and 2B in use with a peritoneal dialysis machine. [Figure 4A] FIG. 2C is a diagram of the calibration of the device of FIGS. 2A and 2B. [Figure 4B] FIG. 2C is a diagram of the calibration of the device of FIGS. 2A and 2B. [Figure 4C] FIG. 2C is a diagram of the calibration of the device of FIGS. 2A and 2B. [Diagram 5] FIG. 1 is a diagram of a device for detecting infection based on color information of a reagent test. [Figure 6B] FIG. 6 is a diagram of the device of FIG. 5 in use with a peritoneal dialysis machine. [Figure 6B] FIG. 6 is a diagram of the device of FIG. 5 in use with a peritoneal dialysis machine. [Figure 7] FIG. 11 is a graph relating to enzyme activity in dialysis wastewater. [Figure 8A] FIG. 6 is a diagram of the device of FIGS. 2A, 2B, and 5 in use with a peritoneal dialysis machine. [Figure 8B] FIG. 6 is a diagram of the device of FIGS. 2A, 2B, and 5 in use with a peritoneal dialysis machine. [Figure 9] FIG. 1 is a diagram of a device for detecting infection based on turbidity of dialysis effluent and color information of reagent tests. [Figure 10A] FIG. 10 is a diagram of the device of FIG. 9 in use with a peritoneal dialysis machine. [Figure 10B] FIG. 10 is a diagram of the device of FIG. 9 in use with a peritoneal dialysis machine. [Figure 11A] FIG. 2 is another diagram of a device for detecting infection based on turbidity of dialysis effluent and color information of reagent tests. [Figure 11B] FIG. 2 is another diagram of a device for detecting infection based on turbidity of dialysis effluent and color information of reagent tests. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] For the sake of brevity and clarity, the description of the embodiments of the present disclosure will be directed to a device for detecting infection from peritoneal dialysis according to the drawings. Although aspects of the present disclosure will be described in relation to the embodiments provided herein, it will be understood that they are not intended to limit the present disclosure to these embodiments. On the contrary, the present disclosure is intended to encompass alternatives, modifications, and equivalents of the embodiments described herein that fall within the scope of the present disclosure as defined by the appended claims. Also, in the following detailed description, specific details are described to provide a thorough understanding of the present disclosure. However, a person of ordinary skill in the art, i.e., a person skilled in the art, will recognize that the present disclosure may be practiced without specific details and / or with multiple details resulting from the combination of aspects of a specific embodiment. In many instances, well-known systems, methods, procedures, and components will not be described in detail so as not to unnecessarily obscure aspects of the embodiments of the present disclosure.

[0016] In embodiments of the present disclosure, the depiction of a given element or discussion or use of a particular element number in a particular figure, or reference in the corresponding description, may encompass the same, equivalent, or similar element or element number identified in another figure or description associated therewith.

[0017] References to an "embodiment / example," "another embodiment / example," "some embodiments / examples," "some other embodiments / examples," etc. indicate that the embodiment / example(s) so described may include a particular feature, structure, characteristic, attribute, element, or limitation, but not all embodiments / examples necessarily include that particular feature, structure, characteristic, attribute, element, or limitation. Also, repeated use of the phrase "in an embodiment / example" or "in another embodiment / example" does not necessarily refer to the same embodiment / example.

[0018] The terms "comprise", "include", "have" and the like do not exclude the presence of features / elements / steps other than those listed in an embodiment. The description of certain features / elements / steps in different embodiments does not indicate that combinations of these features / elements / steps cannot be used in the embodiment.

[0019] As used herein, the words "a" and "an" are defined as one or more. The use of " / " in the figures or related text is understood to mean "and / or" unless otherwise specified. The term "set" is defined as a non-empty, finite organization of elements that mathematically exhibits a cardinality of at least one, according to known mathematical definitions (e.g., a set as defined herein may correspond to a unit set, a singlet set, or a single-element set, or a multi-element set). Terms such as "first," "second," and the like are used merely as labels or identifiers and are not intended to impose numerical requirements on the terms with which they are associated.

[0020] In some representative or exemplary embodiments of the present disclosure, and referring to FIGS. 2A and 2B, there is a device 200 for use with a peritoneal dialysis machine 100 to detect infection in a patient 102 undergoing peritoneal dialysis. The device 200 includes a housing module 202 removably coupleable to a fluid element 204 configured to receive dialysis effluent 130 from the patient 102. The fluid element 204 may have a variety of cross-sectional shapes, such as, for example, cylindrical. The device 200 includes a set of lighting elements 206 disposed on the housing module 202 and configured to emit light into the fluid element 204. The device 200 includes a set of optical sensors 208 disposed on the housing module 202 and configured to measure optical properties of light interacted with the dialysis effluent 130 in the fluid element 204. The device 200 includes a control module configured to measure the turbidity of the dialysis waste fluid 130 based on optical properties, and if the dialysate turbidity and the patient's 102's past dialysate turbidity meet a set of predetermined conditions, the dialysate turbidity indicates an infection, such as peritonitis, in the patient 102.

[0021] In some embodiments, the lighting element 206 includes one or more light emitting diodes (LEDs). For example, the LEDs may include white light LEDs. Alternatively, the LEDs may emit light at a particular wavelength or within a narrow wavelength range, such as 860 nm for infrared light.

[0022] In some embodiments, the optical sensor 208 includes a scattered light sensor 208a for measuring light scattered by the dialysis effluent 130. In some embodiments, the optical sensor 208 includes a transmitted light sensor 208b for measuring light transmitted through the dialysis effluent 130. In particular, the transmitted light sensor 208b and the illumination element 206 are disposed on the housing module 202 such that there is a fluid element 204 between them. In some embodiments, as shown in FIG. 2A, the optical sensor 208 includes both the scattered light sensor 208a and the transmitted light sensor 208b. For example, the scattered light sensor 208a and the transmitted light sensor 208b are located in different areas of the housing module 202 to measure the scattered light and the transmitted light, respectively. The type of the optical sensor 208 may be selected based on the type of the illumination element 206. For example, the scattered light sensor 208a and the transmitted light sensor 208b may use the same type of optical sensor or photodetector. The optical characteristic may include a relationship between the scattered light and the transmitted light.

[0023] If the patient 102 has peritonitis, bacteria, mycobacteria, fungi, and parasites in the peritoneum may induce the production of white blood cells, which are inflammatory markers of infection. White blood cells are typically 12-14 microns in size, and the accumulation of white blood cells in the dialysis effluent 130 leads to an increase in the cloudiness or turbidity of the dialysis effluent 130. As the turbidity increases, the white blood cells in the dialysis effluent 130 increase, scattering the light emitted by the lighting element 206 into the dialysis effluent 130. The scattered light sensor 208a receives a stronger light signal, and the transmitted light sensor 208b receives a weaker light signal. Each of the light signals detected by the scattered light sensor 208a and the transmitted light sensor 208b may be used individually to correlate with the turbidity of the dialysis effluent 130. Alternatively, both light signals may be used together to derive an optical ratio that may be correlated with the turbidity. Combining the light signals from the scattered light sensor 208a and the transmitted light sensor 208b may improve the sensitivity of the light measurement, provide better correlation with turbidity, and improve infection detection compared to the individual light signals. Combining the light signals also helps improve reliability, especially if the lighting element 206 degrades over time, e.g., by reducing brightness.

[0024] In some embodiments, the device 200 further includes a set of lenses 210 for collimating the light emitted from the illumination element 206 into the fluid element 204 and / or for focusing the light onto the optical sensor 208. The lenses 210 serve to improve the signal-to-noise ratio and sensitivity of the light measurement. For example, as shown in FIG. 2B, the lenses 210, which may include one or more focusing lenses, may be placed in front of the illumination element 206 to collimate the light emitted from the illumination element 206 into a parallel beam, which serves to minimize scattering of the light before it reaches the fluid element 204. Similarly, the lenses 210, e.g., focusing lenses, may be placed in front of the scattered light sensor 208a and / or the transmitted light sensor 208b to focus the light onto the respective optical sensor 208. In particular, the optical sensor 208 is located at the focal length of the lenses 210 so that the light can be effectively focused. The lenses 210 may be placed on a support 212 attached to the housing module 202, e.g., by using an optical adhesive that cures under ultraviolet light.

[0025] The fluid element 204 is a disposable part that is replaced after each use of the apparatus 100. The device 200 is reusable with the next disposable fluid element 204 for the next peritoneal dialysis treatment. The fluid element 204 may be pre-sterilized using a suitable method, such as, for example, gamma radiation, ethylene oxide, or electron beam, before being used for a peritoneal dialysis treatment. The fluid element 204 may be pre-attached as part of the disposable tubing used with the apparatus 100. The patient 102 must couple the device 200 to the fluid element 204 before starting a peritoneal dialysis treatment.

[0026] In one embodiment, as shown in Figure 3A, the fluid element 204 is part of or connected to the common line 106, and the patient 102 couples the device 200 to the common line 106. In one embodiment, as shown in Figure 3B, the fluid element 204 is part of or connected to the drain line 118, and the patient 102 couples the device 200 to the drain line 118.

[0027] The patient 102 can use the device 200 to measure the turbidity of the dialysis effluent 130 draining from the patient 102 along the common line 106 and the drain line 118 into the drain bag 116. In one example, the patient 102 can use the device 200 to measure the turbidity during an initial draining phase before starting a peritoneal dialysis treatment. The initial draining phase removes the dialysis effluent 130 from a previous indwelling session. In another example, the patient 102 can use the device 200 to measure the turbidity during a peritoneal dialysis treatment as the dialysis effluent 130 flows along the common line 106 and the drain line 118 into the drain bag 116. In another example, the patient 102 can use the device 200 to measure the turbidity during a final draining phase at the end of a peritoneal dialysis treatment. The final draining phase removes the last of the dialysis effluent 130 from the abdomen before the patient 102 fills the abdomen with fresh dialysate from the fresh bag 110.

[0028] Additionally, the device 200 can measure the turbidity of the dialysis effluent 130 in a dynamic state as it flows through the fluid element 204, for example at a flow rate of 100 ml / min. In this manner, the measurement of turbidity can be integrated into the workflow of a peritoneal dialysis treatment, with less intrusiveness for the patient 102 and reduced interruptions to treatment, as opposed to having to manually take samples of the dialysis effluent 130 for measurement.

[0029] The device 200 may be calibrated before the patient 102 may use it to measure turbidity and detect infection. It has been empirically found that the optical ratio (y) of the scattered light signal to the transmitted light signal is linearly correlated with the turbidity value (x) in the linear equation y=mx+c. Although the sensitivity of the device 200 may be expressed by a slope (m), the light intensity of the illumination element 206, the sensitivity of the optical sensor 208, and the baseline transparency of the transparent housing module 202 may vary slightly, and the baseline optical ratio in the absence of turbid liquid may not be the same for different devices 200.

[0030] Two exemplary devices 200 having the same design but different components, such as different housing modules 202, different lighting elements 206, different optical sensors 208, and different lenses 210, were used to determine the slope (m) representing the sensitivity of the device 200. A priming fluid with a known turbidity value (measured in Nephelometric Turbidity Units (NTU)) was used, such as Baxter Dianeal® peritoneal dialysis fluid. The priming fluid was communicated through the fluid element 204, and the device 200 measured the optical ratio for each turbidity value of the priming fluid. The optical ratio (y-axis) and each NTU (x-axis) for each peritoneal dialysis fluid are plotted in graphs 300, 310 as shown in Figures 4A and 4B for the two devices 200. The slope (m) was found to be 0.2933 and 0.291, respectively, and the offset values ​​(c) were found to be 4.5426 and 5.4636, respectively. The results showed that both devices 200 with the same design but different components share the same sensitivity or response slope based on a slope (m) of about 0.29. Thus, the sensitivity is inherent to the design of device 200 even though different components may be used.

[0031] Since this result establishes that devices 200 with the same design have approximately the same slope (m), before the device 200 can be used, a calibration process including determining the offset value (c) of the device 200 can be performed to calibrate the device 200. The calibration process is performed using a linear equation y=0.29x+c, using a single priming fluid with known NTU, such as fresh dialysate in the fresh bag 110.

[0032] A control module including a computer processor may be configured to perform a series of computerized steps of a calibration process. The steps include measuring optical characteristics of light interacted with fresh dialysate in the fluid element 204, correlating the optical characteristics with turbidity values ​​of the fresh dialysate, and deriving an optical-turbidity profile of the device 200 based on the correlation. The optical-turbidity profile is represented by a linear equation y=0.29x+c, at which point the offset value (c) is known. Once calibrated, the device 200 can be used for peritoneal dialysis, and the optical-turbidity profile is configured to determine the turbidity of the dialysis effluent 130 from the patient 102 based on the optical characteristics of light interacted with the dialysis effluent 130 in the fluid element 204.

[0033] The optical-turbidity profile of the device 200 can be used to predict the turbidity value of the dialysis effluent 130. As shown in the graph 320 of FIG. 4C, the predicted turbidity value 322 is plotted against the measured turbidity value 324 measured using a commercially available turbidimeter. The commercially available turbidimeter is a bulky and expensive instrument that measures fluid turbidity in a static state, in contrast to the device 200, which can measure fluid turbidity in a dynamic state, i.e., while the fluid is flowing. As shown in the graph 320, the predicted turbidity value 322 and the measured turbidity value 324 were found to be very close to each other. This suggests that the calibration process can effectively calibrate the device 200 to derive an optical-turbidity profile for determining the turbidity of the dialysis effluent 130.

[0034] As described above, the control module is configured to measure the turbidity of the dialysate effluent 130 based on an optical characteristic, such as, for example, an optical ratio. The dialysate turbidity is indicative of peritonitis if the dialysate turbidity and the patient's 102 past dialysate turbidity meet a set of predetermined conditions. In one example, the predetermined conditions may include the dialysate turbidity being higher than the past dialysate turbidity averaged over a predetermined duration. More specifically, the predetermined conditions may include the dialysate turbidity being a predetermined percentage, for example, 10%, higher than the average of the past dialysate turbidity over the past few days, such as, for example, 3-5 days, a week, or more. In another example, the predetermined conditions may include the dialysate turbidity being a predetermined number of standard deviations, for example, 1, 2, or 3 standard deviations, from the average of the past dialysate turbidity over the past few days, such as, for example, 3-5 days, a week, or more. Upon determining that the dialysate turbidity meets a predetermined condition, the device 200 may issue an alert or alarm notifying the patient 102 that the patient 102 is preliminarily exhibiting peritonitis.

[0035] The device 200 provides a more objective way of measuring the turbidity of the dialysis effluent 130, allowing earlier and / or more accurate detection of infections, such as peritonitis, in the patient 102. Compared to manual visual observation by the patient 102, which can provide inconsistent quality checks, the device 200 can reduce the risk of false positives and missing true cases of peritonitis. Also, compared to existing bulky and expensive commercially available turbidity meters that measure fluid turbidity under static conditions, the device 200 is small and can be easily integrated into the apparatus 100.

[0036] On the other hand, turbidity is not a specific indicator of peritonitis and may be due to other factors. For example, the cloudy appearance of the dialysis effluent 130 may be caused by non-pathogenic processes, such as general immune reactions, spontaneous fibrin production, and pneumoperitoneum. A high-fat diet of the patient 102 may result in the accumulation of lipoproteins and triglycerides, inducing a milky dialysate and confounding the visual diagnosis of peritonitis. Thus, the device 200 is useful as an objective method for early screening of peritonitis, followed by the need for another test to confirm that the patient 102 actually has peritonitis.

[0037] The confirmatory test is usually performed using a standard peritonitis detection strip, such as a leukostix reagent strip, which is particularly sensitive to the presence of leukocyte esterase, which is released primarily by neutrophils, a type of white blood cell. Peritonitis is usually associated with an increase in both the number and percentage of neutrophils in the dialysis effluent 130. Clinical criteria of 100 cells / μL and more than 50% neutrophils are usually used to detect peritonitis. Also, even if the absolute white blood cell count is less than 100 cells / μL, more than 50% neutrophils in the dialysis effluent 130 is a strong indicator of peritonitis. Typically, the patient 102 dips the reagent strip into the sample of the collected dialysis effluent 130. The patient 102 removes the reagent strip as soon as it is wetted with the dialysis effluent 130 and waits several minutes to determine the color change of the reagent strip. Significant deviations from the protocol, such as dipping the reagent strip for too long or judging a color change too early or too late, can increase the likelihood of misinterpreting the detection results.

[0038] In some representative or exemplary embodiments of the present disclosure, referring to FIG. 5, there is a device 400 for use with a peritoneal dialysis machine 100 to detect an infection in a patient 102 undergoing peritoneal dialysis. The device 400 includes a housing module 402 removably coupleable to a fluid element 404 configured to receive dialysis effluent 130 from the patient 102. The fluid element 404 may have various cross-sectional shapes, such as, for example, cylindrical. The device 400 optionally includes a set of lighting elements 406 disposed on the housing module 402 and configured to emit light into the fluid element 404. The device 400 includes a color sensor 408, such as, for example, an RGB color sensor, disposed on the housing module 402. The color sensor 408 is configured to measure color information of a reagent test element 410, such as, for example, a leukostix reagent strip, disposed in the fluid element 404, which reacts with the dialysis effluent 130 in the fluid element 404 to cause a color change in the reagent test element 410. The reagent test element 410 may be illuminated by the lighting element 406, if present, and / or by ambient lighting. The device 400 includes a control module configured to detect infection, such as peritonitis, based on color information representative of enzyme activity in the dialysis effluent 130 that is indicative of infection in the patient 102.

[0039] In some embodiments, the lighting element 406 includes one or more light emitting diodes (LEDs). For example, the LEDs may include white light LEDs. White light is generally preferred to accurately measure color information of the reagent test element 410.

[0040] The fluid element 404, including the reagent test element 410, is a disposable part that is replaced after each use of the apparatus 100. The device 400 is reusable with the next disposable fluid element 404 for the next peritoneal dialysis treatment. The fluid element 404 may be pre-sterilized using an appropriate method before being used for a peritoneal dialysis treatment. The fluid element 404 may be pre-attached as part of the disposable tubing used with the apparatus 100. The patient 102 must couple the device 400 to the fluid element 404 before starting a peritoneal dialysis treatment. The reagent test element 410 may be manually inserted into the fluid element 404 by the patient 102 before using the device 400. Alternatively, the reagent test element 410 may be pre-inserted into the fluid element 404, e.g., the fluid element 404 is manufactured with the reagent test element 410 enclosed therein.

[0041] In one embodiment, as shown in Figure 6A, the fluid element 404 is part of or connected to the common line 106, and the patient 102 couples the device 400 to the common line 106. In one embodiment, as shown in Figure 6B, the fluid element 404 is part of or connected to the drain line 118, and the patient 102 couples the device 400 to the drain line 118.

[0042] The patient 102 can use the device 400 to measure color information of the reagent test element 410 reacted with the dialysis effluent 130 drained from the patient 102 along the common line 106 and the drain line 118 into the drain bag 116. In one example, the patient 102 can use the device 400 to measure color information during an initial draining stage before starting peritoneal dialysis treatment. In another example, the patient 102 can use the device 400 to measure color information during peritoneal dialysis treatment as the dialysis effluent 130 flows along the common line 106 and the drain line 118 into the drain bag 116. In another example, the patient 102 can use the device 400 to measure turbidity during a final draining stage at the end of peritoneal dialysis treatment.

[0043] Also, to control the wetting time of the reagent test element 410, the fluidic element 404 may include a flow control mechanism configured to selectively communicate the dialysis effluent 130 into and out of the fluidic element 404. The device 400 may be coupled to the common line 106 or the drain line 118. The fluidic element 404 cooperates with the common line 106 / drain line 118 to selectively control the inflow of the dialysis effluent 130 from the common line 106 / drain line 118 into the fluidic element 404 and the outflow of the dialysis effluent 130 from the fluidic element 404 after a predetermined duration. The predetermined duration defines the wetting time of the reagent test element 410, for example, 0.5 to 2 seconds, to ensure that the reagent test element 410 is properly wetted.

[0044] In one embodiment as shown in FIG. 6A, the device 400 is coupled to the common line 106. A valve 420 connects the common line 106 to the fluid element 404 to control the flow of the dialysis effluent 130. The device 400 is sealed, and when the patient valve 105 closes, the valve 420 opens, reversing the fluid flow direction and creating pressure within the device 400. This pressure compresses the air within the device 400 and increases the dialysate level, thereby wetting the reagent testing element 410. The valve 420 then closes, ensuring that the reagent testing element 410 is properly wetted after a predefined duration. The patient valve 105 then remains closed, the flow reverses, and the valve 420 opens. This releases the pressure within the device 400 via the common line 106, and the dialysis effluent 130 is withdrawn from the device 400.

[0045] In one embodiment as shown in FIG. 6B, the device 400 is coupled to the drain line 118. A valve 430 connects the drain line 118 to the fluid element 404 to control the flow of the dialysis effluent 130. The device 400 is sealed, and when the drain valve 120 closes, the valve 430 opens, creating pressure within the device 400. This pressure compresses the air within the device 400, increasing the dialysate level, thereby wetting the reagent test element 410. The valve 430 then closes, ensuring that the reagent test element 410 is properly wetted after a predefined duration. The drain valve 120 then opens, followed by the valve 430. This releases the pressure within the device 400 via the drain line 120, and the dialysis effluent 130 is withdrawn from the device 400.

[0046] A control module including a computer processor is configured to perform a computerized method for detecting an infection, such as peritonitis, based on color information of the reagent test element 410. The method includes controlling a color sensor 408 to measure color information of the reagent test element 410 reacted with the dialysis effluent 130 for a predetermined duration. The method includes measuring color information of the reagent test element 410 for a predetermined period of time after the predetermined duration. The predetermined period of time, which may be 0.5 to 5 minutes after the predetermined duration, ensures that the reagent test element 410 is measured within an appropriate time window. The method includes extracting RGB color data from the color information and detecting an infection in the patient 102 based on the RGB color data, the RGB color data representing an enzyme activity indicative of an infection in the patient 102.

[0047] In some embodiments, the method includes converting the extracted RGB color data to second color data in a second color space and determining the enzyme activity based on the second color data, the second color data representing the enzyme activity. The second color space may include a CIELAB, CIE XYZ, or YCbCr color space.

[0048] In one embodiment, the RGB color data is converted to the CIELAB color space. * a* b * The CIELAB color space, also called the color space, is a linear regression model defined by the International Commission on Illumination (CIE) that relates light intensity (black to white). * , a for colors from green to red * , and b for colors from blue to yellow * The color is expressed by three values: * and b * The values ​​represent the four colors inherent to human vision: red, green, blue, and yellow. Thus, the CIELAB color space is closer to the nature of the visual sensation of the human eye.

[0049] The method may include denoising the RGB colour data prior to converting the denoised RGB colour data to a CIELAB colour space. For example, the RGB colour data may be denoised using methods such as filtering and / or outlier removal. For example, the outlier removal may include removing RGB colour data that is beyond a third interquartile range. The method may include deriving index parameters from the CIELAB colour data converted from the denoised RGB colour data and determining the enzyme activity based on the index parameters. More specifically, the RGB colour data within a given time period is converted into a plurality of samples of CIELAB colour data. For each sample, a * The mean of the values ​​is removed, and (mean removed) a * The absolute value of the sample a for a given period is calculated. * The absolute values ​​of are summed and then normalized by the number of samples. The index parameter is the normalized a * It is derived from the absolute value of

[0050] As shown in the graph 500 of FIG. 7, the indicator parameter is correlated with the enzyme activity. The enzyme activity may be related to the activity level of leukocyte esterase in the dialysate. The leukocyte esterase activity is correlated with the amount of neutrophils and serves as a surrogate marker indicative of the amount of neutrophils present in the dialysate. Thus, the enzyme activity in the dialysis effluent 130 may be determined based on the determined indicator parameter and the graph 500, and the enzyme activity may be indicative of peritonitis.

[0051] The advantage of using the CIELAB color space is that it is almost independent of color intensity (due to the light intensity from the lighting element 406) and depends on color discrimination. The graph 500 shows that different leukocyte esterase enzyme activity levels can be well discriminated based on the indicator parameters. This allows the indicator parameters to discriminate leukocyte esterase activity with high resolution, reducing the subjectivity of the measurement compared to the conventional method using several color palettes as a reference, where the patient 102 may have difficulty discriminating between these colors. Thresholds can be empirically developed from clinical data to diagnose positive and negative peritonitis cases. The thresholds for positive case diagnosis can be fine-tuned to balance the sensitivity and specificity of peritonitis detection.

[0052] In one embodiment, the RGB color data is transformed to the CIE XYZ color space, where X represents the non-negative RGB color mix, Y represents luminance, and Z represents the blue channel information. Corresponding index parameters can be derived from the second color data in the CIE XYZ color space, similar to the index parameters from the CIELAB color data, with minimal dependence on luminance and with the blue channel information removed.

[0053] In one embodiment, the RGB color data is converted to a YCbCr color space, where Y represents the luminance or light intensity component, Cb represents the blue-difference color component, and Cr represents the red-difference color component. Corresponding index parameters can be derived from the second color data in the YCbCr color space, similar to the index parameters from the CIELAB color data, where the Cr component in the YCbCr color space is the a component in the CIELAB color space. * It can be used to replace the value.

[0054] In one embodiment, the RGB color data can be directly used to derive corresponding index parameters for determining enzyme activity.

[0055] In some embodiments, devices 200, 400 are used in combination in apparatus 100 to increase the overall specificity of infection diagnostic accuracy. Device 200 allows for early screening of infection based on turbidity of dialysis effluent 130, and if the early screening preliminarily indicates infection, device 400 is triggered to perform a more sensitive detection of infection. Devices 200, 400 may be used in sequence such that if turbidity preliminarily indicates infection, patient 102 inserts a reagent test element 410 into fluid element 404 for a confirmatory test. Alternatively, patient 102 may use a fluid element 404 that already contains a reagent test element 410. This conserves the number of reagent test elements 410 used during peritoneal dialysis, since device 400 is used only if device 200 triggers an early screening alert.

[0056] In one embodiment, as shown in Figure 8A, the patient 102 couples the devices 200, 400 to the common line 106. In one embodiment, as shown in Figure 8B, the patient 102 couples the devices 200, 400 to the drain line 118. The patient 102 can use the devices 200, 400 during an initial drainage phase before starting peritoneal dialysis therapy, during peritoneal dialysis therapy, or during a final drainage phase at the end of peritoneal dialysis therapy.

[0057] In some representative or exemplary embodiments of the present disclosure, and referring to FIG. 9 , there is a device 600 for use with a peritoneal dialysis machine 100 to detect infection in a patient 102 undergoing peritoneal dialysis. The device 600 is an integrated device that combines the functions of the devices 200, 400. The device 600 includes a housing module 602 that is removably coupleable to a fluid element 604 configured to receive dialysis effluent 130 from the patient 102. The fluid element 604 may have a variety of cross-sectional shapes, such as, for example, cylindrical. The device 600 includes a set of lighting elements 606 disposed on the housing module 602 and configured to emit light into the fluid element 604.

[0058] The device 600 includes a set of optical sensors 608 disposed on the housing module 602 and configured to measure optical characteristics of light interacting with the dialysate effluent 130 in the fluidic element 204 and to measure color information of a reagent test element 610 disposed in the fluidic element 604, which reacts with the dialysate effluent 130 in the fluidic element 604, thereby causing a color change in the reagent test element 610. The device 600 includes a control module configured to measure turbidity of the dialysate effluent 130 based on the optical characteristics, which indicates an infection in the patient 102 if the dialysate turbidity and the historical dialysate turbidity of the patient 102 meet a set of predetermined conditions. The control module is further configured to detect the infection based on the color information, which indicates an enzyme activity in the dialysate effluent 130 indicative of an infection.

[0059] The optical sensor 608 includes a scattered light sensor 608a for measuring light scattered by the dialysis effluent 130, and a transmitted light sensor 608b for measuring light transmitted through the dialysis effluent 130. The optical sensor 608 further includes a color sensor 608c for measuring color information of the reagent test element 610. It will be appreciated that the scattered light sensor 608a, the transmitted light sensor 608b, and the color sensor 608c are similar to the scattered light sensor 208a, the transmitted light sensor 208b, and the color sensor 408, respectively.

[0060] The lighting element 606 includes at least one first lighting element 606a that cooperates with a scattered light sensor 608a and a transmitted light sensor 608b. The lighting element 606 includes at least one lighting element 606b that cooperates with a color sensor 608c. It will be appreciated that the first lighting element 606a and the second lighting element 606b are similar to lighting elements 206 and 406, respectively. Alternatively, the lighting element 606 may include a single lighting element that cooperates with all of the optical sensors 608.

[0061] The fluidic element 604 may include a flow control mechanism configured to selectively communicate the dialysis effluent 130 into and out of the fluidic element 604 after a predetermined duration. Similar to the fluidic element 404, the predetermined duration defines a wetting time of the reagent test element 610, such as, for example, 0.5 to 2 seconds. When the dialysis effluent 130 is in communication with the fluidic element 604, the scattered light sensor 608a and the transmitted light sensor 608b can measure the turbidity of the dialysis effluent 130. When the dialysis effluent 130 is discharged from the fluidic element 604, the color sensor 608c proceeds to measure color information of the reagent test element 610 that has reacted with the dialysis effluent 130.

[0062] The fluid element 604, including the reagent test element 610, is a disposable part that is replaced after each use of the apparatus 100. The device 600 is reusable with the next disposable fluid element 604 for the next peritoneal dialysis treatment. The fluid element 604 may be pre-sterilized using an appropriate method before use in a peritoneal dialysis treatment. The fluid element 604 may be pre-attached as part of the disposable tubing used with the apparatus 100. The patient 102 must couple the device 600 to the fluid element 604 and, optionally, calibrate the device 600 before starting the peritoneal dialysis treatment. The reagent test element 610 may be manually inserted into the fluid element 604 by the patient 102 before use of the device 600. Alternatively, the reagent test element 610 may be pre-inserted into the fluid element 604, e.g., the fluid element 604 is manufactured with the reagent test element 610 enclosed therein.

[0063] The patient 102 first uses the device 600 to measure color information of the reagent test element 610 reacted with the dialysis effluent 130 during an initial draining phase that removes the dialysis effluent 130 from a previous indwelling session. The fluid control mechanism controls the inflow and outflow of the dialysis effluent 130 in the fluid element 604 for a predetermined duration. The patient 102 then begins peritoneal dialysis treatment and uses the device 600 to measure the turbidity of the dialysis effluent 130 drained from the patient 102, which flows continuously through the fluid element 604. In one example, the patient 102 can use the device 600 to measure the turbidity during peritoneal dialysis treatment as the dialysis effluent 130 flows along the common line 106 and the drain line 118 to the drain bag 116. In another example, the patient 102 can use the device 600 to measure the turbidity during the final draining phase at the end of the peritoneal dialysis treatment. The turbidity-based measurement results of the dialysis effluent 130 and the color information of the reagent test element 610 can complement each other and increase the overall accuracy of infection detection. The device 600 is capable of detecting infections, such as peritonitis, with greater sensitivity and specificity.

[0064] In one embodiment as shown in FIG. 10A, the fluid element 604 is part of or connected to the common line 106, and the patient 102 couples the device 600 to the common line 106. The valve 620 may connect the common line 106 to the fluid element 604 to control the flow of the dialysis effluent 130. In one embodiment as shown in FIG. 10B, the fluid element 604 is part of or connected to the drain line 118, and the patient 102 couples the device 600 to the drain line 118. The valve 630 may connect the drain line 118 to the fluid element 604 to control the flow of the dialysis effluent 130. It will be appreciated that the valves 620, 630 operate similarly to the valves 420, 430 described above.

[0065] 11A and 11B show some other configurations of the device 600. In particular, the housing module 602 may have a polygonal structure with several polygonal sides. In one embodiment as shown in FIG. 11A, the first lighting element 606a for the scattered light sensor 608a and the transmitted light sensor 608b is disposed on one side, and the transmitted light sensor 608b is disposed on the opposite side. The scattered light sensor 608a is disposed on another side so as to be perpendicular to the first lighting element 606a and the transmitted light sensor 608b. The color sensor 608c and the second lighting element 606b for the color sensor 608c are disposed on another two different sides. In one embodiment as shown in FIG. 11B, there is a single lighting element 606 for all the optical sensors 608. The lighting element 606 and the transmitted light sensor 608b are disposed on sides opposite each other. The scattered light sensor 608a is positioned on another side so as to be perpendicular to the illumination element 606 and the transmitted light sensor 608b. The color sensor 608c is positioned on another side.

[0066] It is recognized that various aspects of the devices 200, 400, 600 may be equally applicable to each other and will not be detailed for the sake of brevity. It is also recognized that the control module described herein includes a processor, memory, and various other modules or components. The modules and components are configured to perform various operations or steps and are configured as part of the processor. Such operations or steps are performed in response to non-transitory instructions operable or executed by the processor. The memory is used to store instructions and possibly data that are read during program execution. The memory may be referred to as a computer-readable storage medium and / or a non-transitory computer-readable medium depending on the context. A non-transitory computer-readable medium includes all computer-readable media except those that are themselves transitory propagating signals.

[0067] In this way, the devices 200, 400, 600 provide an improved method of more accurately detecting infections, such as peritonitis, in patients 102 undergoing peritoneal dialysis. For example, the devices 200, 400 allow early screening of preliminary signs of peritonitis, which can then be confirmed using a reagent test. Screening first and then confirming is a great economic advantage, as screening is very inexpensive and not burdensome for the patient 102, even on a daily basis.

[0068] Patients 102 suffering from or at risk of suffering from peritonitis can be identified earlier so that medical intervention can be provided earlier. Once diagnosed, treatment of peritonitis usually takes about 4-10 days. The earlier the diagnosis, the less damage peritonitis causes to the peritoneum and the more effective and less costly treatment can be. Peritonitis carries a high risk of cardiovascular disease and severe infections can result in systemic sepsis that can lead to death. Thus, early treatment means that infected patients 102 can be treated more effectively and mortality can be reduced. The devices 200, 400, 600 are effective in early and accurate detection of peritonitis and more patients 102 can adopt these devices 200, 400, 600 for home dialysis.

[0069] In the above detailed description, embodiments of the present disclosure related to a device for detecting infection from peritoneal dialysis are described with reference to the figures provided. The description of various embodiments herein does not claim or limit only to specific or specific expressions of the present disclosure, but merely represents non-limiting examples of the present disclosure. The present disclosure serves to address at least one of the difficulties and problems associated with the prior art described above. Although only some embodiments of the present disclosure are disclosed herein, it is apparent to those skilled in the art that various changes and / or modifications may be made to the disclosed embodiments in light of the present disclosure without departing from the scope of the present disclosure. Therefore, the scope of the present disclosure and the following claims are not limited to the embodiments described herein.

Claims

1. 1. A device for detecting infection in a patient undergoing peritoneal dialysis, comprising: a housing module removably connectable to a fluidic element configured to receive dialysis effluent from the patient; a set of lighting elements disposed on the housing module and configured to emit light into the fluid element; a set of optical sensors disposed on the housing module and configured to measure optical characteristics of the light interacting with the dialysis effluent in the fluid element; a control module configured to measure the turbidity of the dialysis effluent based on the optical property; Equipped with The device, wherein the measured dialysate turbidity indicates an infection in the patient if the dialysate turbidity and the patient's past dialysate turbidity meet a set of predetermined conditions when compared to each other, the past dialysate turbidity being derived from dialysate turbidity measurements of the patient over the previous few days.

2. The device of claim 1 , wherein the optical sensor comprises a scattered light sensor for measuring the light scattered by the dialysis effluent and a transmitted light sensor for measuring the light transmitted through the dialysis effluent.

3. 3. The device of claim 2, wherein the optical characteristic comprises an optical ratio (y) between the scattered light and the transmitted light, and the device is pre-calibrated such that the optical ratio (y) and the measured dialysate turbidity (x) are substantially linearly correlated by y = mx + c, where m represents the sensitivity of the device and c represents an offset value.

4. The device of any one of claims 1 to 3, further comprising a set of lenses for collimating the light emitted from the illumination element into the fluid element and / or for focusing the light onto the optical sensor.

5. The device of claim 1 , further comprising the fluidic element removably coupled to the housing module.

6. 10. The device of claim 1, wherein the predetermined condition comprises the measured dialysate turbidity being higher than the historical dialysate turbidity averaged over the preceding several days.

7. 1. A device for detecting infection in a patient undergoing peritoneal dialysis, comprising: A housing module; a fluidic element removably coupled to the housing module and configured to receive dialysis effluent from the patient; a color sensor configured to measure color information of a reagent test element disposed within the fluidic element that has reacted with the dialysis effluent in the fluidic element; a control module configured to detect an infection based on the color information representative of an enzyme activity in the dialysis effluent indicative of an infection in the patient; Equipped with the fluidic element includes a flow control mechanism configured to selectively control the flow of the dialysis effluent into the fluidic element; the flow control mechanism is further configured to recover the dialysis effluent from the fluidic element by selectively controlling the outflow of the dialysis effluent from the fluidic element after a predetermined duration from the inflow of the dialysis effluent into the fluidic element; The predetermined duration controls the wetting time of the reaction between the reagent test element and the dialysis effluent.

8. The device of claim 7 , further comprising a set of lighting elements disposed on the housing module and configured to emit light into the fluidic element.

9. the color sensor comprises an RGB color sensor, and the control module Extracting RGB color data from the color information; converting the RGB color data into second color data in a second color space; determining the enzyme activity based on the second color data 9. A device according to claim 7 or 8, configured for

10. The device of claim 9 , wherein the control module is configured to denoise the RGB color data and convert the denoised RGB color data to the second color data.

11. The device of claim 9 or 10, wherein the control module is configured for deriving an index parameter from the second color data, and the enzyme activity is determined based on the index parameter.

12. The device of claim 9 , wherein the second color space comprises a CIELAB, CIE XYZ, or YCbCr color space.

13. 1. A device for detecting infection in a patient undergoing peritoneal dialysis, comprising: A housing module; a fluidic element removably coupled to the housing module and configured to receive dialysis effluent from the patient; a set of lighting elements disposed on the housing module and configured to emit light into the fluid element; disposed on the housing module; measuring an optical characteristic of the light that has interacted with the dialysis effluent in the fluid element; configured to measure color information of a reagent test element disposed within the fluidic element that has reacted with the dialysis waste fluid in the fluidic element; the fluidic element includes a flow control mechanism configured to selectively control the flow of the dialysis effluent into the fluidic element; the flow control mechanism is further configured to recover the dialysis effluent from the fluidic element by selectively controlling the outflow of the dialysis effluent from the fluidic element after a predetermined duration from the inflow of the dialysis effluent into the fluidic element; a set of optical sensors that controls a wetting time of the reaction between the reagent test element and the dialysis effluent, the predetermined duration being and determining a turbidity of the dialysate effluent based on the optical characteristic, the dialysate turbidity being indicative of an infection in the patient if the determined dialysate turbidity and the patient's historical dialysate turbidity satisfy a set of predetermined conditions; Detecting the infection based on the color information representing the enzyme activity in the dialysis wastewater indicative of the infection A control module configured for 16. A device comprising:

14. The optical sensor includes: a scattered light sensor for measuring the light scattered by the dialysis waste liquid; a transmitted light sensor for measuring the light transmitted through the dialysis waste liquid; a color sensor for measuring the color information; The device of claim 13 , comprising:

15. The device of claim 14 , wherein the optical property comprises an optical ratio of the scattered light to the transmitted light.

16. The optical sensor includes an RGB color sensor for measuring the color information, and the control module further includes: Extracting RGB color data from the color information; converting the RGB color data into second color data in a second color space; determining the enzyme activity based on the second color data A device according to any one of claims 13 to 15, configured for

17. The device of claim 16 , wherein the control module is configured to denoise the RGB color data and convert the denoised RGB color data to the second color data.

18. 18. The device of claim 16 or 17, wherein the control module is configured for deriving an index parameter from the second color data, and the enzyme activity is determined based on the index parameter.

19. 17. The device of claim 16, wherein the second color space comprises a CIELAB, CIE XYZ, or YCbCr color space.

20. 1. A computerized method for detecting infection in a patient undergoing peritoneal dialysis, comprising: measuring color information of a reagent test element reacted with dialysis effluent from said patient for a predetermined duration and for a predetermined period of time after said predetermined duration; extracting RGB color data from the color information within the predetermined period of time; converting the RGB color data within the predetermined time period into a plurality of samples of CIELAB color data; deriving index parameters from the plurality of samples of CIELAB color data; detecting an infection based on the indicator parameter, the indicator parameter representing an enzyme activity in the dialysis effluent indicative of an infection in the patient; A method for providing the above.

21. 21. The method of claim 20, further comprising: denoising the RGB color data; and converting the denoised RGB color data to the CIELAB color data.

Images