A bilirubin adsorber and a method for detecting a bilirubin concentration

Abstract

The application provides a bilirubin adsorber and a method for detecting the concentration of bilirubin. The bilirubin adsorber comprises an adsorber body and a bilirubin detector. The adsorber body is provided with a limiting groove, and the bilirubin detector is arranged in the limiting groove. The area of the adsorber body corresponding to the limiting groove is provided with a transparent detection window, so that the bilirubin detector can detect the concentration of bilirubin in the plasma inside the adsorber body through the detection window. The application can accurately detect the concentration of bilirubin, and facilitate medical staff to accurately determine the saturation degree of the bilirubin adsorber.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a bilirubin adsorbent and a method for detecting bilirubin concentration. Background Technology

[0002] Blood bilirubin adsorption involves separating the blood plasma from the blood to be adsorbed, and then passing the plasma through a bilirubin adsorber for specific adsorption. This process adsorbs and removes bilirubin from the plasma, significantly reducing the bilirubin concentration in the blood to be adsorbed.

[0003] Existing bilirubin adsorbents are typically single-use consumables, with a usage time generally ranging from 120 to 180 minutes. Clinically, during blood purification, healthcare professionals usually determine the saturation level of the bilirubin adsorbent based on the instruction manual or past experience. However, they cannot accurately determine the saturation time, leading to the blood purification process ending before the adsorbent reaches saturation, wasting the adsorbent material, or continuing adsorption even after saturation, increasing the risks of blood purification. Furthermore, current technologies usually require blood tests after purification to determine if further purification is needed, but the time interval for obtaining test results generally reduces the efficiency of bilirubin adsorption. Summary of the Invention

[0004] The present invention aims to overcome the above-mentioned deficiencies of the prior art and provides a bilirubin adsorbent and a method for detecting bilirubin concentration, so as to accurately detect the concentration of bilirubin and facilitate medical personnel to accurately determine the saturation level of the bilirubin adsorbent.

[0005] To address the above problems, a first aspect of the present invention provides a bilirubin adsorbent, comprising:

[0006] The adsorber body is provided with a limiting groove.

[0007] A bilirubin detector, wherein the bilirubin detector is disposed within the limiting groove;

[0008] The area on the adsorber body corresponding to the limiting groove has a transparent detection window, so that the bilirubin detector can detect the bilirubin concentration of the plasma inside the adsorber body through the detection window.

[0009] Furthermore, the adsorber body includes a column and two end-sealing members. The column is hollow inside, and the two end-sealing members are used to seal both ends of the column along the first direction. At least one end of the column is provided with the detection window, and the detection window has a groove.

[0010] At least one of the sealing members is provided with the limiting groove, one end of the limiting groove along the first direction passes through the sealing member and communicates with the groove.

[0011] Furthermore, the sealing member includes an end cap and an opaque locking nut. The end cap is used to seal the end of the column along the first direction. The end cap is connected to the column through the locking nut, and the limiting groove is provided on the locking nut.

[0012] Furthermore, the bilirubin detector includes a detector body and a detection head. The detection head protrudes from the detector body along a second direction and extends into the interior of the groove. A reflective optical sensor is disposed inside the detection head. The second direction is perpendicular to the first direction.

[0013] Furthermore, the outer peripheral wall of the column has a protruding limiting ring, which is located close to the detection window. One end of the detector body abuts against the limiting ring, and the other end of the detector body abuts against the locking nut.

[0014] The end cap is provided with a locking protrusion, which abuts against the end of the detection head away from the limiting ring, and the locking protrusion extends into the interior of the groove.

[0015] Furthermore, the detector body includes a housing, on which a display screen is disposed. The display screen is located at one end of the housing opposite to the detection head along a second direction, and the display screen is used to display the bilirubin concentration of the plasma inside the adsorber body.

[0016] A second aspect of the present invention provides a method for detecting bilirubin concentration, comprising:

[0017] The real-time bilirubin concentration is detected using the bilirubin adsorbent described in the first aspect.

[0018] Based on the bilirubin concentrations obtained at multiple time points, it is determined whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0019] Further, determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the detected bilirubin concentrations at multiple time points includes:

[0020] Based on the bilirubin concentrations obtained at multiple time points, a curve of bilirubin concentration changing over time was fitted.

[0021] When the slope of the curve is not greater than a first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0022] Further, determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the detected bilirubin concentrations at multiple time points includes:

[0023] The standard deviation of bilirubin concentration is determined based on the bilirubin concentration at multiple time points obtained from the test.

[0024] When the standard deviation is not greater than the second preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0025] Furthermore, the real-time bilirubin concentration is detected using the bilirubin adsorbent, including:

[0026] The real-time bilirubin concentration at the plasma inlet and the real-time bilirubin concentration at the plasma outlet are detected by the bilirubin adsorber.

[0027] The step of determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the bilirubin concentrations obtained at multiple time points includes:

[0028] The concentration difference between the plasma inlet and outlet at the same time is determined based on the bilirubin concentration at any one of the multiple time points detected.

[0029] When the concentration difference is not greater than a third preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0030] The bilirubin adsorber of the present invention, by setting a bilirubin detector on the adsorber body, allows medical staff to detect the bilirubin concentration of plasma inside the adsorber body through a transparent detection window. This enables medical staff to understand the bilirubin removal status in a timely manner, and medical staff can infer the bilirubin saturation level inside the adsorber body based on changes in bilirubin concentration. This achieves accurate detection of bilirubin saturation level inside the adsorber body, avoiding the uncertainty of judgment based on experience and eliminating the need to draw blood to test bilirubin concentration after blood purification. This improves the convenience of use for medical staff and increases the efficiency of the bilirubin adsorber.

[0031] The bilirubin concentration detection method described in this invention can detect the real-time bilirubin concentration using a bilirubin adsorber. Based on the bilirubin concentrations obtained at multiple time points, it can be determined in a timely manner whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation. This achieves accurate detection of bilirubin saturation within the adsorber body, avoiding the uncertainty of judgment based on experience and eliminating the need to draw blood to test bilirubin concentration after blood purification. This allows medical staff to quickly determine whether blood purification is needed again, improving the convenience for medical staff and increasing the efficiency of the bilirubin adsorber. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the main structure of the bilirubin adsorber provided in an embodiment of the present invention;

[0033] Figure 2 This is a partial structural diagram of the bilirubin adsorber provided in an embodiment of the present invention without a bilirubin detector;

[0034] Figure 3 for Figure 2 A schematic diagram of the cross-sectional structure;

[0035] Figure 4 for Figure 1 A schematic diagram of the cross-sectional structure along plane AA;

[0036] Figure 5 for Figure 4 A partial structural diagram;

[0037] Figure 6 This is a three-dimensional structural schematic diagram of the bilirubin detector provided in an embodiment of the present invention;

[0038] Figure 7 This is a schematic diagram of the front view structure of the bilirubin detector provided in an embodiment of the present invention;

[0039] Figure 8 A flowchart for detecting bilirubin concentration provided in an embodiment of the present invention;

[0040] Figure 9 A curve showing the change of bilirubin concentration over time, provided in an embodiment of the present invention;

[0041] Figure 10 Another curve showing the change of bilirubin concentration over time, provided in an embodiment of the present invention;

[0042] Figure 11 This is a schematic diagram of the operation of the bilirubin adsorber provided in an embodiment of the present invention. Detailed Implementation

[0043] The technical solution of the present invention will now be clearly and thoroughly described in conjunction with the accompanying drawings. In this description, it should be noted that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are merely for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. Additionally, in the description of the present invention, "at least one" means one or more, unless otherwise explicitly specified.

[0044] In this specification, the term "as an alternative embodiment" means that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one alternative embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same implementation or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0045] Combination Figure 1 and Figure 3 As shown, a first aspect of this embodiment provides a bilirubin adsorber, including: an adsorber body 10 and a bilirubin detector 20. A limiting groove 30 is provided on the adsorber body 10, and the bilirubin detector 20 is disposed within the limiting groove 30, wherein:

[0046] The area on the adsorber body 10 corresponding to the limiting groove 30 has a transparent detection window 111, so that the bilirubin detector 20 can detect the bilirubin concentration of the plasma inside the adsorber body 10 through the detection window 111.

[0047] The bilirubin adsorber provided in this embodiment, by setting a bilirubin detector on the adsorber body, can detect the bilirubin concentration of plasma inside the adsorber body through a transparent detection window. This allows medical staff to understand the bilirubin removal status in a timely manner, and medical staff can infer the bilirubin saturation level inside the adsorber body based on changes in bilirubin concentration. This achieves accurate detection of bilirubin saturation level inside the adsorber body, avoiding the uncertainty of judgment based on experience and eliminating the need to draw blood to test bilirubin concentration after blood purification. This improves the convenience of use for medical staff and increases the efficiency of the bilirubin adsorber.

[0048] Based on the above embodiments, as an optional implementation method, combined with Figure 2 and Figure 3 As shown, the adsorber body 10 includes a column 11 and two end caps 12. The column 11 has openings at both ends along the axial direction (i.e., the first direction). The inside of the column 11 is hollow. The end caps 12 are used to seal the openings of the column 11. The two end caps 12 are respectively installed at the two openings along the axial direction of the column 11. At least one end of the column 11 is provided with a detection window 111. The detection window 111 has a groove recessed towards the inside of the column 11. The groove can be an arc-shaped groove. At least one end cap 12 is provided with a limiting groove 30. One end of the limiting groove 30 along the first direction passes through the end cap 12 and communicates with the groove. Thus, by providing a groove on the column 11, and having one end of the limiting groove 30 pass through the end cap 12 and communicate with the groove, the distance between the bilirubin detector 20 and the detection window 111 can be reduced, which is beneficial to further improve the accuracy of the bilirubin detector 20 in detecting the bilirubin concentration of plasma inside the adsorber body 10.

[0049] Based on the above embodiments, as an optional implementation method, combined with Figures 4 to 5 As shown, the end-sealing component 12 includes an end cap 121 and a locking nut 122. The end cap 121 is used to seal the opening of the column cylinder 11, and the end cap 121 is connected to the column cylinder 11 through the locking nut 122. Specifically, the locking nut 122 is threaded to the outer peripheral wall of the column cylinder 11, so that the end cap 121 is fixedly connected to the column cylinder 11 through the locking nut 122. A limiting groove 30 is provided on the locking nut 122, and the locking nut 122 is an opaque locking nut. Thus, by providing the limiting groove 30 on the locking nut 122, the sealing performance of the end-sealing component 12 can be avoided, thereby not affecting the adsorption performance and safety performance of the adsorbent body 10. In addition, the opaque locking nut 122 can block light during bilirubin detection by the bilirubin detector 20, preventing light from penetrating the locking nut 122, so that light can only be received by the bilirubin detector 20, which is beneficial to improving the accuracy of bilirubin concentration detection by the bilirubin detector 20.

[0050] Based on the above embodiments, as an optional implementation, the end cap 12 further includes a cap 123, a mesh frame 124, and a sealing ring 125. The end cap 121 is provided with a blood nozzle 211 and a cover body 1212 protruding axially from the cylinder 11. The cover body 1212 surrounds the blood nozzle 211, and the cover body 1212 and the blood nozzle 211 are integrally formed. The blood nozzle 1211 communicates with the inner space of the cover body 1212. The cover body 1212 extends into the inner cavity of the cylinder 11. Part of the outer peripheral wall of the cover 12 contacts part of the inner wall of the column cylinder 11. The mesh frame 124 is disposed between the end of the cover 1212 and the column cylinder 11. A filter screen is disposed on the mesh frame 124, and the filter screen covers the end opening of the column cylinder 11. The sealing ring 125 is disposed in the space enclosed by the outer peripheral wall of the cover 1212, the mesh frame 124 and the inner wall of the column cylinder 11 to ensure the sealing of the end cap 12. The cap 123 is used to cover the blood nozzle 1211 to achieve a seal on the blood nozzle 1211.

[0051] Based on the above embodiments, as an optional implementation method, combined with Figure 6 and Figure 7As shown, the bilirubin detector 20 includes a detector body and a detection head 21 disposed on the detector body. The detection head 21 protrudes from the detector body in the radial direction (i.e., the second direction). The detector body is located in the limiting groove 30, and the detection head 21 extends into the interior of the groove. The detection head 21 can contact the detection window 111. A reflective optical sensor is disposed inside the detection head 21. The reflective optical sensor detects the bilirubin concentration by means of light reflection. The reflective optical sensor has its own light source and light receiving device. The light source is used to emit light into the interior of the column 11, and the light receiving device is used to receive the reflected light inside the column 11. The light density difference is converted to obtain the bilirubin concentration of the plasma inside the adsorber body 10. As an optional implementation, the light source emits white light (wavelength 430nm to 490nm) to illuminate the plasma in the column 11. Bilirubin in the plasma absorbs some of the light, but it cannot absorb blue light (wavelength 450nm or 460nm) or green light (wavelength 550nm). Furthermore, the locking nut 122 is opaque, thus blocking light and preventing it from passing through. This allows the unabsorbed blue and green light to be reflected to the light receiving device. The density difference between these two wavelengths of light (blue and green) conforms to Beer-Lambert's law regarding bilirubin concentration. The bilirubin concentration is obtained by converting the density difference between these two wavelengths. Therefore, by installing a reflective optical sensor inside the detection head 21, non-contact measurement of bilirubin concentration can be achieved, and the bilirubin concentration can be calculated based on the density difference between the two wavelengths, which is more accurate than relying on empirical judgment of bilirubin concentration. In this embodiment, the specific type of light receiving device in the reflective optical sensor is not further limited. Those skilled in the art can select common light receiving devices in the prior art according to the actual situation. Based on the above embodiment, as an optional implementation, the light source of the detection head 21 can continuously emit white light, or the light source of the detection head 21 can intermittently emit white light. If it is intermittent emission, the interval time is 1 minute to 5 minutes.

[0052] Based on the above embodiments, as an optional implementation, the detector body includes a housing 22, with a detection head 21 protruding from the housing 22. A processor and a memory are disposed inside the housing 22. The processor is electrically connected to the memory and the detection head 21 via a bus. The memory stores program instructions executable by the processor, which calls the program instructions to execute the bilirubin concentration detection method as described in the second aspect. Furthermore, the reflective optical sensor can transmit the density difference between the detected blue and green light wavelengths to the processor, which can calculate the bilirubin concentration based on the density difference between the two wavelengths.

[0053] Based on the above embodiments, as an optional implementation, the detector body also includes a display screen 23. The display screen 23 is disposed on the housing 22 and is located at one end of the housing 22 in the radial direction away from the detection head 21. The display screen 23 is used to display the bilirubin concentration of the plasma inside the adsorber body 10. The display screen 23 is electrically connected to the processor. After the processor calculates the bilirubin concentration based on the density difference between the two wavelengths of light, it transmits the bilirubin concentration to the display screen 23 for display, so that medical staff can view it in real time.

[0054] Based on the above embodiments, as an optional implementation, the end face of the display screen 23 on the housing 22 is flush with the outer peripheral wall of the sealing member 12, or the end face of the display screen 23 on the housing 22 protrudes from the outer peripheral wall of the sealing member 12. If the end face of the display screen 23 on the housing 22 protrudes from the outer peripheral wall of the sealing member 12, the distance between the end face of the display screen 23 on the housing 22 and the outer peripheral wall of the sealing member 12 is less than or equal to 5 mm. That is, the end face of the display screen 23 on the housing 22 does not protrude from the outer peripheral wall of the locking nut 122, and the distance between the end face of the display screen 23 on the housing 22 and the outer peripheral wall of the locking nut 122 is less than or equal to 5 mm. Therefore, the outer surface of the bilirubin detector 20 can be made approximately flush with the outer peripheral wall of the sealing member 12, avoiding an increase in the size and floor space of the bilirubin adsorbent, and also facilitating packaging and transportation.

[0055] Based on the above embodiments, as an optional implementation, the detector body also includes a wireless transmission module and a battery module. Both the wireless transmission module and the battery module are disposed inside the housing 22. The wireless transmission module is electrically connected to the processor. The processor can transmit the bilirubin concentration to a mobile device such as a mobile phone or computer via the wireless transmission module, enabling the mobile device to receive the bilirubin concentration data. This allows medical personnel to monitor and view the bilirubin concentration in real time, enabling timely replacement of the saturated adsorber body 10, or timely monitoring of the patient's blood purification status, allowing for rapid on-site determination of whether continued blood purification is necessary. The battery module is electrically connected to the detection head 21, the processor, the display screen 23, and the wireless transmission module, respectively, providing power to these components. In this embodiment, both the wireless transmission module and the battery module can adopt common structures found in the prior art. For example, the wireless transmission module can be a 4G chip, a 5G chip, a WiFi module, or a Bluetooth module, and the battery module can include a lithium battery.

[0056] Based on the above embodiments, as an optional implementation, a switch 24 is also provided on the housing 22. The switch 24 and the display screen 23 are located on the same end face of the housing 22. The switch 24 has a switching circuit electrically connected to the battery module inside, and the switch 24 is used to control the bilirubin detector 20 to turn on or off. The switching circuit in this embodiment can adopt a structure commonly found in the prior art, and those skilled in the art can select one according to the actual situation.

[0057] Based on the above embodiments, as an optional implementation, the bilirubin detector 20 is detachably disposed within the limiting groove 30. Specifically, the outer peripheral wall of the cylinder 11 has a protruding limiting ring 112, which is located near the detection window 111. One end of the detector body in the axial direction abuts against the limiting ring, and the other end of the detector body in the axial direction abuts against the locking nut 122 in the sealing member 12, so that the bilirubin detector 20 is engaged within the limiting groove 30. Thus, the limiting ring 122 can support the detector body, and the limiting ring 122 and the locking nut 122 cooperate to engage the bilirubin detector 20 within the limiting groove 30. As another optional implementation, a groove can also be provided on the locking nut 122, and a slider that cooperates with the groove can be provided on the detector body, so that the bilirubin detector 20 is detachably disposed within the limiting groove 30. In this embodiment, the bilirubin detector is detachably mounted on the adsorbent body via a limiting groove. This allows the adsorbent body to be used only once, while the bilirubin detector can be reused. This not only allows for the detection of bilirubin concentration but also reduces the operating cost of the bilirubin adsorbent. Alternatively, the bilirubin detector 20 can be fixedly mounted within the limiting groove 30, thus securing it to the adsorbent body 10. Exemplarily, the bilirubin detector 20 can be fixedly connected to the limiting groove 30 by adhesive. Preferably, the detachable mounting of the bilirubin detector 20 within the limiting groove 30 allows for reusability of the bilirubin detector, further reducing the operating cost of the bilirubin adsorbent.

[0058] Based on the above embodiments, as an optional implementation, the locking nut 122 is provided with a retaining protrusion 1221, which abuts against the end of the detection head 21 away from the limiting ring 112, and the retaining protrusion 1221 extends into the interior of the groove. Therefore, when the bilirubin detector 20 is inserted into the limiting groove 30, the detection head 21 is inserted into the interior of the groove, and the retaining protrusion 1221 can engage in the gap between the detection head 21 and the groove, thereby more firmly securing the bilirubin detector 20 within the limiting groove 30, improving the assembly stability of the bilirubin detector 20, and also contributing to improving the accuracy and stability of the assembly between the locking nut 122 and the cylinder 11. As an optional implementation, the retaining protrusion 1221 can be a flexible retaining protrusion; for example, the retaining protrusion 1221 can be a retaining protrusion made of silicone material.

[0059] Based on the above embodiments, as an optional implementation, each of the locking nuts 122 of the two end caps 12 is provided with a limiting groove 30, and a bilirubin detector 20 is detachably installed in each limiting groove 30. Therefore, by providing bilirubin detectors 20 on both end caps 12, the bilirubin concentration at the plasma inlet and plasma outlet of the adsorber body 10 can be detected separately, thereby enabling more timely and accurate determination of bilirubin concentration changes and more precise detection of bilirubin saturation within the adsorber body.

[0060] Based on the above embodiments, as an optional implementation, the locking nuts of the two end caps 12 are of different colors to facilitate the distinction between the plasma inlet end and the plasma outlet end of the adsorber body 10, thereby avoiding misjudgment of bilirubin concentration changes. For example, one end cap 12 has a red locking nut, and the other end cap 12 has a blue locking nut.

[0061] In this embodiment, the column 11 can be a transparent column 11. The inside of the column 11 is used to load the adsorbent and the preservation solution. The adsorbent can be a styrene-based anion exchange resin, cellulose, agarose, or other materials with bilirubin adsorption function. The preservation solution can be physiological saline or water for injection. The column 11, end cap 121, locking nut 122, cap 123, and other structures are made of PC or PP material.

[0062] Figure 8 This is a flowchart for detecting bilirubin concentration provided in an embodiment of the present invention. (In conjunction with...) Figure 8 As shown, a second aspect of the present invention provides a method for detecting bilirubin concentration, comprising:

[0063] The real-time bilirubin concentration is detected using a bilirubin adsorbent in the first aspect.

[0064] Based on the bilirubin concentrations obtained at multiple time points, it is determined whether the bilirubin adsorber has reached saturation.

[0065] The bilirubin concentration detection method provided in this embodiment can detect the real-time bilirubin concentration using a bilirubin adsorber. Based on the bilirubin concentrations obtained at multiple times, it can be determined in a timely manner whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation. This achieves accurate detection of bilirubin saturation within the adsorber body, avoiding the uncertainty of judgment based on experience and eliminating the need to draw blood to test bilirubin concentration after blood purification. This allows medical staff to quickly determine whether blood purification is needed again, improving the convenience for medical staff and increasing the efficiency of the bilirubin adsorber.

[0066] In this embodiment, a bilirubin detector 20 can be detachably installed on the adsorber body 10. The bilirubin detector 20 is installed on the locking nut 122 at the plasma inlet end of the adsorber body 10, or the bilirubin detector 20 is installed on the locking nut 122 at the plasma outlet end of the adsorber body 10. By detecting the bilirubin concentration at the plasma inlet end or the bilirubin concentration at the plasma outlet end through the bilirubin adsorber, it is possible to accurately determine whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation, and the operating cost of the bilirubin adsorber can be reduced.

[0067] Combination Figure 11 As shown, during the adsorption of bilirubin from plasma by the bilirubin adsorber, the plasma is in circulation. Therefore, when a bilirubin detector 20 is installed on the adsorber body 10, it can be installed on the locking nut 122 at the plasma inlet end of the adsorber body 10, or on the locking nut 122 at the plasma outlet end of the adsorber body 10. Preferably, installing the bilirubin detector 20 on the locking nut 122 at the plasma outlet end of the adsorber body 10 allows for more accurate detection of the bilirubin concentration in the plasma after adsorption by the adsorber body 10.

[0068] Based on the above embodiments, as an optional implementation, if a bilirubin detector 20 is detachably installed on the adsorber body 10, then based on the detected bilirubin concentrations at multiple times, it is determined whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation, including:

[0069] Based on the bilirubin concentrations obtained at multiple time points, a curve of bilirubin concentration changing over time was fitted.

[0070] When the slope of the curve is not greater than the first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0071] Specifically, the bilirubin detector 20 continuously emits white light through its detection head to continuously detect the bilirubin concentration at the plasma inlet or outlet at multiple time points. Using each time point as the abscissa and the corresponding bilirubin concentration at the plasma inlet or outlet at each time point as the ordinate, a curve of bilirubin concentration changing with time is fitted, and the slope of the curve is calculated in real time. When the slope of the curve is not greater than a first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0072] Figure 9 This is a curve showing the change in bilirubin concentration over time, where the vertical axis represents μmol / L and the horizontal axis represents minutes. Figure 9As shown, the slope of the curve gradually decreases and eventually flattens out, meaning the absolute value of the curve's slope gradually decreases until the slope is no greater than the first preset threshold. This indicates that the bilirubin adsorbent's adsorption capacity for bilirubin is gradually weakening until the bilirubin adsorbent reaches saturation. Where the first preset threshold is K, then -0.05 < K ≤ 0.

[0073] In this embodiment, by fitting a curve of bilirubin concentration changing over time, and by judging whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation by the slope of the curve, the concentration of bilirubin adsorbed by the bilirubin adsorber can be continuously monitored, thereby more accurately determining the time when the bilirubin adsorber reaches saturation.

[0074] Based on the above embodiments, as another optional implementation, if a bilirubin detector 20 is detachably installed on the adsorber body 10, then based on the detected bilirubin concentrations at multiple times, it is determined whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation, including:

[0075] The standard deviation of bilirubin concentration is determined based on the bilirubin concentration at multiple time points obtained from the test.

[0076] When the standard deviation is not greater than the first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0077] Specifically, the detection head 21 of the bilirubin detector 20 intermittently emits white light to detect the bilirubin concentration at the plasma inlet or outlet at at least three time points. The standard deviation of the bilirubin concentration at these three time points is calculated. When the standard deviation is not greater than a second preset threshold, it is determined that the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation. The interval between any two adjacent time points in the at least three time points is 1 to 5 minutes. Therefore, when the standard deviation is not greater than the second preset threshold, it indicates that the bilirubin concentration variation detected by the bilirubin detector 20 at the at least three time points is small, and the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation.

[0078] In this embodiment, the second preset threshold is less than or equal to 1.0 μmol / L. Setting the second preset threshold within this range allows for a more accurate determination of whether the bilirubin adsorbent has reached saturation.

[0079] In this embodiment, by determining the standard deviation of the bilirubin concentration and using the standard deviation to determine whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation, the concentration of bilirubin adsorbed by the bilirubin adsorber can be intermittently detected, thereby improving the efficiency of determining the time when the bilirubin adsorber reaches saturation.

[0080] In this embodiment, two bilirubin detectors 20 can be detachably installed on the adsorber body 10. The two bilirubin detectors 20 are respectively installed on the locking nut 122 at the plasma inlet end and the locking nut 122 at the plasma outlet end of the adsorber body 10. By detecting the bilirubin concentration at the plasma inlet end and the bilirubin concentration at the plasma outlet end through the bilirubin adsorber, the difference between the bilirubin concentration at the plasma inlet end and the bilirubin concentration at the plasma outlet end can be directly confirmed. This makes it easier for medical staff to judge in a timely and accurate manner whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation, which is beneficial to improving detection efficiency.

[0081] Based on the above embodiments, as an optional implementation, if two bilirubin detectors 20 are detachably installed on the adsorber body 10, the real-time bilirubin concentration is detected by the bilirubin adsorber, including:

[0082] The real-time bilirubin concentration at the plasma inlet and outlet was detected using a bilirubin adsorbent.

[0083] Based on the bilirubin concentrations obtained at multiple time points, determine whether the bilirubin adsorber has reached saturation, including:

[0084] The concentration difference between the plasma inlet and outlet at the same time is determined based on the bilirubin concentration at any time from multiple time points detected.

[0085] When the concentration difference is not greater than the third preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0086] Specifically, a bilirubin detector 20 installed on the locking nut 122 at the plasma inlet end of the adsorber body 10 detects the bilirubin concentration at the plasma inlet end at multiple times. A bilirubin detector 20 installed on the locking nut 122 at the plasma outlet end of the adsorber body 10 detects the bilirubin concentration at the plasma outlet end at multiple times. At any one of the multiple times, the concentration difference between the bilirubin concentration at the plasma inlet end and the bilirubin concentration at the plasma outlet end at that time is calculated. When the concentration difference is not greater than a third preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0087] In this embodiment, the third preset threshold is less than or equal to 1.0 μmol / L. Setting the third preset threshold within this range allows for a more accurate determination of whether the bilirubin adsorbent has reached saturation.

[0088] In this embodiment, by determining the concentration difference between the bilirubin concentration at the plasma inlet and the plasma outlet at the same time, and using the concentration difference to determine whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation, it is possible to determine in a timely and accurate manner whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation, which is beneficial to improving detection efficiency.

[0089] Based on the above embodiments, as another optional implementation, if two bilirubin detectors 20 are detachably installed on the adsorber body 10, the real-time bilirubin concentration can be detected through the bilirubin adsorber, including:

[0090] The real-time bilirubin concentration at the plasma inlet and outlet was detected using a bilirubin adsorbent.

[0091] Based on the bilirubin concentrations obtained at multiple time points, determine whether the bilirubin adsorber has reached saturation, including:

[0092] Based on the bilirubin concentrations obtained at multiple time points, a first curve showing the change of bilirubin concentration at the plasma inlet over time and a second curve showing the change of bilirubin concentration at the plasma outlet over time were fitted respectively.

[0093] When the slope of the first curve and / or the second curve is not greater than the first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

[0094] Figure 10 This is another curve showing the change in bilirubin concentration over time, where the vertical axis is in μmol / L and the horizontal axis is in minutes. (Combined with...) Figure 10As shown, the first and second curves exhibit similar trends, with both curves gradually decreasing in slope and eventually flattening out. Furthermore, as time progresses, the two curves approach or intersect, indicating that the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation. While the proximity or intersection of the first and second curves can indicate whether the bilirubin adsorber has reached saturation, in practical use, the sensitivity of the two bilirubin detectors or the composition of the plasma can influence the bilirubin concentration detected by the two detectors, potentially leading to errors. This could result in the bilirubin adsorber reaching saturation even though the first and second curves do not intersect, or both curves flatten out but maintain a large difference, thus potentially causing judgment errors and affecting detection accuracy. Therefore, in this embodiment, to improve detection accuracy, it is possible to determine whether the slope of at least one of the two curves is not greater than a first preset threshold to ascertain whether the bilirubin adsorber has reached saturation. To improve the convenience of detection, those skilled in the art can determine whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation simply by judging whether the slope of the first curve or the second curve is not greater than a first preset threshold.

[0095] Based on the above embodiments, as an optional implementation method, the bilirubin concentration detection method further includes:

[0096] Once the bilirubin adsorber reaches saturation, it issues an alarm. The alarm can be audible or visual, alerting healthcare professionals that the adsorber body 10 is saturated. This allows for timely replacement of the adsorber body 10 or termination of blood purification. The bilirubin adsorber or detector may also include an audible alarm module and / or a visual alarm module. If, after the adsorber body 10 is saturated, the bilirubin concentration at either the plasma inlet or outlet remains higher than normal, healthcare professionals can replace the adsorber body 10 and continue blood purification. If, after the adsorber body 10 is saturated, the bilirubin concentration at the plasma inlet is not higher than normal, healthcare professionals can terminate blood purification. Therefore, issuing an alarm via the bilirubin adsorber allows healthcare professionals to promptly understand when the adsorber has reached saturation and quickly determine whether further blood purification is needed, improving the feasibility of precision medicine.

[0097] Based on the above embodiments, as an optional implementation method, the bilirubin concentration detection method further includes:

[0098] The bilirubin adsorbent wirelessly transmits real-time bilirubin concentration data to a mobile device, and stores this data in a memory, generating a report. This allows medical staff to easily monitor bilirubin concentration changes, more intuitively determine if the adsorbent has reached saturation, and receive an alarm notification when saturation is detected. This alerts medical staff to promptly terminate blood purification or replace the adsorbent for restarting the process, preventing them from missing alarms. Storing the real-time bilirubin concentration data in the memory and generating a report facilitates subsequent review and analysis by medical staff.

[0099] In this embodiment, the bilirubin detector detects the bilirubin concentration of the plasma inside the adsorber body 10 through the detection window 111 in the following manner:

[0100] The bilirubin detector emits white light through the detection window 111 and receives the reflected blue and green light. The bilirubin concentration is calculated based on the density difference between the two wavelengths of light, blue and green. The density difference between the two wavelengths of light, blue and green, and the bilirubin concentration conform to Beer-Lambert's law.

[0101] Specifically, the detection head 21 of the bilirubin detector 20 emits white light (wavelength 430nm to 490nm) through the detection window 111. This white light illuminates the plasma in the column 11. The bilirubin in the plasma absorbs some of the light, but it cannot absorb blue light (wavelength 450nm or 460nm) or green light (wavelength 550nm). Furthermore, the locking nut 122 is opaque, thus blocking light. The light cannot pass through the locking nut 122, causing the unabsorbed blue and green light to be reflected back to the detection head 21 and received by the light receiving device inside. The density difference between the blue and green light wavelengths conforms to Beer-Lambert's law, and the bilirubin concentration is obtained by converting the density difference between these two wavelengths.

[0102] The bilirubin adsorbent of this embodiment includes a memory and a processor. The memory stores program instructions that can be executed by the processor. The processor can execute the bilirubin concentration detection method as described above by calling the program instructions.

[0103] The processor can be a CPU (Central Processing Unit), a general-purpose processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field Programmable Gate Array), or other programmable logic devices, transistor logic devices, hardware components, or any combination thereof. It can implement or execute the various exemplary logic blocks, modules, and circuits described in conjunction with the disclosure of this application. The processor can also be a combination that implements computational functions, exemplary including one or more microprocessor combinations, combinations of DSPs and microprocessors, etc.

[0104] A bus can include a pathway for transmitting information between the aforementioned components. The bus can be a PCI (Peripheral Component Interconnect) bus or an EISA (Extended Industry Standard Architecture) bus, etc. Buses can be categorized as address buses, data buses, control buses, etc.

[0105] The memory may be ROM (Read Only Memory) or other types of static storage devices capable of storing static information and instructions, RAM (Random Access Memory) or other types of dynamic storage devices capable of storing information and instructions, or EEPROM (Electrically Erasable Programmable Read Only Memory), CD-ROM (Compact Disc Read Only Memory) or other optical disc storage, optical disc storage (including compressed optical discs, laser discs, optical discs, digital universal optical discs, Blu-ray discs, etc.), magnetic disk storage media or other magnetic storage devices, or any other medium capable of carrying or storing desired program code in the form of instructions or data structures and accessible by a computer, but not limited thereto.

[0106] The memory stores the application code that executes the solution of this application, and its execution is controlled by the processor. The processor executes the application code stored in the memory to implement the content shown in the foregoing method embodiments.

[0107] While the disclosure is as stated above, its scope of protection is not limited thereto. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of this disclosure, and all such changes and modifications will fall within the protection scope of this invention.

Claims

1. A bilirubin adsorbent, characterized in that, include: The adsorber body is provided with a limiting groove. A bilirubin detector, wherein the bilirubin detector is disposed within the limiting groove; The area on the adsorber body corresponding to the limiting groove has a transparent detection window, so that the bilirubin detector can detect the bilirubin concentration of the plasma inside the adsorber body through the detection window. The main body of the adsorber includes a column and two end caps. At least one end of the column is provided with the detection window, which has a groove. At least one of the sealing members is provided with the limiting groove, and one end of the limiting groove along the first direction passes through the sealing member and communicates with the groove. The end cap includes an end cap and an opaque locking nut. The end cap is connected to the cylindrical tube via the locking nut, and the limiting groove is provided on the locking nut. The bilirubin detector includes a detector body and a detection head. The outer peripheral wall of the cylinder has a protruding limiting ring. The limiting ring is located close to the detection window. One end of the detector body abuts against the limiting ring, and the other end of the detector body abuts against the locking nut. The end cap is provided with a locking protrusion, which abuts against the end of the detection head away from the limiting ring, and the locking protrusion extends into the interior of the groove.

2. The bilirubin adsorbent according to claim 1, characterized in that, The cylinder is hollow inside, and the two end caps are used to seal both ends of the cylinder along the first direction.

3. The bilirubin adsorbent according to claim 1, characterized in that, The end cap is used to seal the end of the cylinder along the first direction.

4. The bilirubin adsorbent according to claim 1, characterized in that, The detection head protrudes from the detector body along the second direction and extends into the interior of the groove. A reflective optical sensor is disposed inside the detection head, and the second direction is perpendicular to the first direction.

5. The bilirubin adsorbent according to claim 1, characterized in that, The detector body includes a housing, on which a display screen is provided. The display screen is located at one end of the housing opposite to the detection head along a second direction, and the display screen is used to display the bilirubin concentration of the plasma inside the adsorber body.

6. A method for detecting bilirubin concentration, characterized in that, include: Real-time bilirubin concentration is detected using the bilirubin adsorbent according to any one of claims 1 to 5; Based on the bilirubin concentrations obtained at multiple time points, it is determined whether the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

7. The detection method according to claim 6, characterized in that, The step of determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the bilirubin concentrations obtained at multiple time points includes: Based on the bilirubin concentrations obtained at multiple time points, a curve of bilirubin concentration changing over time was fitted. When the slope of the curve is not greater than a first preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

8. The detection method according to claim 6, characterized in that, The step of determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the bilirubin concentrations obtained at multiple time points includes: The standard deviation of bilirubin concentration is determined based on the bilirubin concentration at multiple time points obtained from the test. When the standard deviation is not greater than the second preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

9. The detection method according to claim 6, characterized in that, The real-time bilirubin concentration is detected using the bilirubin adsorbent, including: The real-time bilirubin concentration at the plasma inlet and the real-time bilirubin concentration at the plasma outlet are detected by the bilirubin adsorber. The step of determining whether the bilirubin concentration adsorbed by the bilirubin adsorber has reached saturation based on the bilirubin concentrations obtained at multiple time points includes: The concentration difference between the plasma inlet and outlet at the same time is determined based on the bilirubin concentration at any one of the multiple time points detected. When the concentration difference is not greater than a third preset threshold, it is determined that the concentration of bilirubin adsorbed by the bilirubin adsorber has reached saturation.

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