Method of characterizing fluid flowing through conduit using system comprising optical emitter and detector
By arranging multiple optical emitters and detectors on the non-circular catheter, combining HDR sensing and processor analysis, the problem of insufficient dynamic range when detecting high and low concentrations of blood in the prior art is solved, and accurate detection of blood concentration and robust analysis of fluid composition are achieved.
Patent Information
- Application Number
- CN202380080298.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-11-21
- Filing Date
- 2023-11-21
- Publication Date
- 2025-06-27
AI Technical Summary
Existing fluid characterization systems have insufficient dynamic range when detecting high and low concentrations of blood, resulting in inaccurate detection, especially when the flow of fluid through the catheter is unpredictable.
Using a high dynamic range (HDR) sensing system, the concentration of the fluid component is determined by arranging multiple optical emitters and detectors on the non-circular conduit and using optical signals transmitted from different axes, combined with the processor to analyze the data.
Accurate detection of high and low concentration blood is achieved, adapted to dark fluids with a larger concentration range in the catheter, without the need for an optical detector with a wide sensitivity range, providing more robust and rich data.
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Figure CN120225864A_ABST
Abstract
Description
[0001] Cross - Reference to Related Applications
[0002] This application claims the benefit of priority and all rights of U.S. Provisional Patent Application No. 63 / 426,909, filed on November 21, 2022, the entire content of which is hereby incorporated by reference in its entirety. Background Art
[0003] For example, during a surgical procedure, inaccurate characterization of the fluid removed from a patient can endanger the patient's health or unnecessarily consume medical resources. For example, when the fluid is blood, overestimating the blood loss can lead to an unnecessary consumption of transfusion - grade blood and may pose unnecessary clinical risks to the patient. As another example, underestimating the blood loss may result in delays in resuscitation and blood transfusion, increasing the risk of infection, tissue death, or even patient death (e.g., in the case of bleeding).
[0004] Some existing fluid characterization systems utilize optical emitter - detector pairs that are disposed opposite each other around a circular catheter. These systems typically exhibit deficiencies when the fluid contains a high concentration of darker - colored fluid components because these components attenuate a relatively large portion of the optical signal transmitted through the fluid. A particularly interesting example is a high concentration of blood in the fluid, where the optical signal may attenuate so much by the time it reaches the optical detector that it cannot produce results accurate enough for the sensitivity range of the optical detector. One solution is to increase the light intensity of the light source to ensure that enough light reaches the optical detector. However, when the fluid contains no or a small amount of blood, increasing the light intensity may exceed the upper sensitivity limit of the optical detector. Alternatively, adjusting the gain setting of the optical detector has similar drawbacks. In fact, existing systems lack the detection range required to characterize in real - time a fluid containing high - and low - concentration blood that is being rapidly drawn through a catheter with unpredictable flow.
[0005] When detecting blood in a fluid, it is known to emit light of different wavelengths, such as infrared light and visible green light. Another drawback of existing systems using emitter - detector pairs is limited data. In other words, the processor receives data only from a single detector of each emitter - detector pair, and only the underlying aspects of the fluid can be characterized from this data. However, it is desirable for an improved fluid characterization system to generate more robust and richer data, which can be used with more advanced processing techniques to perform a more detailed analysis of the fluid in real - time. Summary of the Invention
[0006] Among other things, the present disclosure provides high dynamic range (HDR) sensing to characterize a fluid flowing within a catheter. The HDR sensing can accommodate a large concentration range of dark fluids (e.g., blood) within the catheter without requiring the optical detector to have a wide sensitivity range. It should be understood that the HDR sensing can be used in combination with other aspects of the present disclosure provided herein, such as the triggering sequence of the optical transmitter, scattered signal processing, multivariate analysis, etc.
[0007] According to a first aspect, a method of characterizing a fluid flowing through a non-circular catheter using a system including a first and a second optical transmitter, a first and a second optical detector, and a processor is provided. The method includes transmitting a first optical signal along a first axis through the non-circular catheter and the fluid using the first optical transmitter. Once the first optical signal is transmitted through the catheter and the fluid, the first optical detector detects the first optical signal that is at least partially absorbed by the fluid as the optical signal travels along the first axis through the fluid. The method includes transmitting a second optical signal along a second axis different from the first axis through the non-circular catheter using the second optical transmitter such that the relative path of one of the first and second optical signals through the non-circular catheter is shorter than the other. Similar to the first optical signal and the first optical detector, the second optical detector detects the second optical signal that is at least partially absorbed by the fluid. Finally, the method includes determining the concentration of the fluid component within the fluid based on the first and second optical signals.
[0008] According to a second aspect, a method of characterizing a fluid flowing through a catheter using a system including a first and a second optical transmitter, a first and a second optical detector, and a processor is provided. The method includes repeatedly transmitting an optical signal through the catheter and the fluid using the optical transmitter. After the optical signal is transmitted, the optical signal that is at least partially absorbed and scattered by the fluid is detected by each of the first and second optical detectors. In addition, the optical transmitter and the first and second optical detectors are arranged in an array around the catheter such that the distance between the optical transmitter and each of the first and second optical detectors is different. After the optical signal passes through the fluid, the processor is configured to determine an absorbance value and a scatter value of each optical signal based on data from each of the first and second optical detectors. Finally, the concentration of the fluid component within the fluid is determined based on the absorbance and scatter values.
[0009] According to a third aspect, there is provided a method of characterizing a fluid flowing through a catheter using a system including a first and a second optical emitter, a first and a second optical detector, and a processor. The method begins by transmitting first and second optical signals using the first and second optical emitters such that they pass through the catheter and the fluid. The optical signals are detected by each of the first and second optical detectors after passing through the fluid and being at least partially absorbed and scattered by the fluid. In terms of arrangement, the first and second optical emitters and the first and second optical detectors are arranged around the catheter in an array such that the distances between combinations of the first and second optical emitters and the first and second optical detectors are different. Further, the processor is configured to determine an absorbance value and a scatter value for each of the first and second optical signals based on data from each of the first and second optical detectors to provide a data matrix, and to determine the concentration of the fluid components in the fluid based on the data matrix.
[0010] According to a fourth aspect, there is provided a method of characterizing a fluid flowing through a catheter using a system including an optical emitter arranged around the catheter in an array, an optical detector arranged around the catheter in an array, and a processor. The method includes transmitting an optical signal through the catheter and the fluid using each optical emitter. The optical emitters are activated sequentially in an arrangement order around the catheter, one at a time. Subsequently, the optical detector detects the optical signal that has been at least partially absorbed and scattered by the fluid. Finally, the processor determines an absorbance value and a scatter value for each optical signal based on data from the optical detector, and determines the concentration of the fluid components in the fluid based on the absorbance value and the scatter value.
[0011] According to a fifth aspect, there is provided a method of characterizing a fluid flowing through a catheter using a system including an optical emitter arranged around the catheter in an array, an optical detector arranged around the catheter in an array, and a processor. The method includes transmitting an optical signal through the catheter and the fluid using a first optical emitter among the optical emitters. Subsequently, an optical detector adjacent to or closest to the first optical emitter among the optical detectors is used to detect the optical signal that has been at least partially absorbed and scattered by the fluid. Finally, the processor determines an absorbance value and a scatter value for each optical signal based on data from the optical detector, and determines the concentration of the fluid components in the fluid based on the absorbance value and the scatter value.
[0012] According to a sixth aspect, a medical waste collection system is provided. The medical waste collection system includes a vacuum pump and a container in fluid communication with the vacuum pump, the container being configured to collect fluid under the influence of the suction of the vacuum pump. The system further includes a sensor module that includes a housing, a transmitter, and a detector. The transmitter and the detector are positioned adjacent to and outside the outer wall of the container, the transmitter being configured to emit an optical signal, and the detector being configured to detect the optical signal absorbed and / or scattered by the fluid within the container. Finally, the system includes a processor in electronic communication with the sensor module, the processor being configured to receive sensor data from the detector and characterize the fluid composition of the fluid.
[0013] According to a seventh aspect, a sensor module for characterizing fluid from a patient is provided. The sensor module includes a housing having a sidewall that has a longer side length and a shorter side length that together define a non-circular lumen. A first and a second light-emitting diode are coupled to the housing and are respectively configured to output optical signals of a first wavelength and a second wavelength. The second wavelength is less than the first wavelength. Additionally, a first and a second detector are coupled to the housing. The first detector is configured to detect the optical signal of the first wavelength from the first light-emitting diode and the scattered optical signal of the second wavelength from the second light-emitting diode, while the second detector is configured to detect the optical signal of the second wavelength from the second light-emitting diode and the scattered optical signal of the first wavelength from the first light-emitting diode. The second light-emitting diode and the second detector are positioned on or adjacent to the sidewall at the shorter side length to be positioned across a larger cross-sectional dimension.
[0014] According to an eighth aspect, an optical transmitter for use with a sensor module to characterize fluid from a patient is provided. The optical transmitter includes a transmitter configured to output optical signals of multiple wavelengths. To output optical signals of multiple wavelengths, the sensor module includes an optical waveguide that couples the optical transmitter to each of a first and a second light-emitting diode. The first light-emitting diode is configured to output an optical signal of the first wavelength among the multiple wavelengths, and the second light-emitting diode is configured to output an optical signal of the second wavelength among the multiple wavelengths. These optical signals originate from the light-emitting diodes, propagate along the optical waveguide, and pass through the optical transmitter.
[0015] According to a ninth aspect, a sensor module for characterizing a fluid from a patient is provided. The sensor module includes a housing configured to be coupled to a non-circular catheter. The housing has a first catheter seat arranged to be positioned adjacent to one side of the non-circular catheter when the housing is coupled to the non-circular catheter. The housing further includes a second catheter seat arranged to be positioned adjacent to the opposite side of the non-circular catheter when the housing is coupled to the non-circular catheter. More specifically, when the housing is coupled to the non-circular catheter, the first and second catheter seats define a lumen. The lumen includes a smaller cross-sectional dimension and a larger cross-sectional dimension greater than the smaller cross-sectional dimension. In addition to the housing, the sensor module further includes a first light-emitting diode coupled to the housing and configured to output an optical signal of a first wavelength, and a second light-emitting diode coupled to the housing and configured to output an optical signal of a second wavelength different from the first wavelength. To detect the light from the light-emitting diodes, the sensor module further includes a first detector coupled to the housing opposite the first light-emitting diode with respect to the smaller cross-sectional dimension, and a second detector coupled to the housing opposite the second light-emitting diode with respect to the larger cross-sectional dimension. The first detector is configured to detect the optical signal of the first wavelength from the first light-emitting diode and the scattered optical signal of the second wavelength from the second light-emitting diode, and the second detector is configured to detect the optical signal of the second wavelength from the second light-emitting diode and the scattered optical signal of the first wavelength from the first light-emitting diode.
[0016] Any of the above aspects may be combined, in whole or in part, with any other aspect. Any of the above aspects, whether combined in whole or in part, may be further combined, in whole or in part, with any of the following embodiments.
[0017] To provide different propagation paths for the optical signals from the light-emitting diodes, the first and second axes along which the optical signals are transmitted may be perpendicular to each other. The first axis and the second axis may be transverse to the longitudinal axis of the non-circular catheter. The first axis and the second axis may correspond to a respective one of the larger cross-sectional dimension and the smaller cross-sectional dimension of the non-circular catheter. The non-circular catheter may be oval, ovoid, hexagonal, octagonal, or rectangular.
[0018] To avoid signal mixing, the step of transmitting the second optical signal may be performed after the step of transmitting the first optical signal, such that only one of the first optical transmitter and the second optical transmitter is operable at a time. To this end, the method may include the step of alternately transmitting the first optical signal and the second optical signal. The step of alternately transmitting may be continuously and repeatedly performed during operation of the system.
[0019] The method may include transmitting a first optical signal at a first wavelength; and transmitting a second optical signal at a second wavelength different from the first wavelength. The method may further include comparing the first optical signal with a sensor sensitivity threshold using a processor and performing the step of transmitting the second optical signal in response to the first optical signal being below the sensor sensitivity threshold.
[0020] The step of determining the fluid component concentration may further include analyzing the first and second optical signals using a parametric model generated by a machine-trained neural network.
[0021] The method may include generating a first scattered light value indicative of at least partial scattering of the first optical signal by the fluid using a second optical detector, generating a second scattered light value indicative of at least partial scattering of the second optical signal by the fluid using a first optical detector, and further determining the concentration of the fluid component based on the first and second scattered light values using a processor.
[0022] Each optical transmitter and each optical detector may be arranged in an array around the conduit such that the distances between each combination of the first and second optical transmitters and the first and second optical detectors are different. The optical transmitters and optical detectors may be coupled to the outer diameter of the conduit to form a ring. The optical detectors may be arranged at different angles relative to each optical transmitter.
[0023] The sensor module may further include a processor communicatively coupled to at least one of the first light-emitting diode, the second light-emitting diode, the first detector, and the second detector. The processor may be configured to determine the concentration of the fluid component of the fluid flowing through the non-circular conduit based on the optical signals detected by the first and second detectors and the scattered light signals detected by the first and second detectors. To this end, the processor may be configured to determine the concentration of the fluid component of the fluid flowing through the non-circular conduit by analyzing the optical signals and the scattered light signals using a parametric model generated by a machine-trained neural network. The processor may further be configured to determine an absorbance value and a scattering value for each of the first optical signal, the second optical signal, and the scattered light signal based on the data from each of the first and second optical detectors to provide a data matrix and determine the concentration of the fluid component in the fluid flowing through the non-circular conduit based on the data matrix of the absorbance values and the scattering values.
[0024] Finally, the method may include displaying the concentration of the fluid component on a display. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The advantages of the present invention can be better understood by referring to the following detailed description in conjunction with the accompanying drawings, and thus the advantages of the present invention will be readily appreciated.
[0026] Figure 1AA representation of a fluid characterization system, where a sensor module is coupled to a conduit. The conduit can be coupled to a manifold configured to be received within a medical waste collection system. Additionally or alternatively, a pipette can be coupled to a cartridge configured to be received within a console.
[0027] Figure 1B is Figure 1A A schematic diagram of a fluid characterization system, including a suction device, a conduit, a sensor module, a container, and a vacuum source.
[0028] Figure 2A is Figure 1A and 1B A perspective view of the sensor module.
[0029] Figure 2B is Figure 2A A cross-sectional view of the sensor module depicted in
[0030] Figure 2C is Figure 2A A cross-sectional view of another embodiment of the sensor module depicted in
[0031] Figure 3A is Figure 2B A cross-sectional view of the sensor module depicted in , schematically showing the positions of an optical emitter and an optical detector disposed around a non-circular conduit.
[0032] Figure 3B is Figure 2C A cross-sectional view of the sensor module depicted in , schematically showing the positions of an optical emitter and an optical detector disposed around another non-circular conduit.
[0033] Figure 4A and 4B A schematic diagram showing an optical signal being emitted from an optical emitter, passing through a non-circular conduit, and being received by an optical detector.
[0034] Figure 5A and 5B A schematic diagram where an optical signal passing through a non-circular conduit can be detected to determine the fill level of the fluid within the conduit.
[0035] Figure 6 A schematic diagram showing an optical signal and a scattered signal generated by the optical signal passing through a non-circular conduit.
[0036] Figure 7A A cross-sectional view of the sensor module, where a "one-to-many" arrangement is schematically shown.
[0037] Figure 7B A cross-sectional view of the sensor module, where a "many-to-one" arrangement is schematically shown.
[0038] Figure 7C and 7D is a cross-sectional view of a sensor module, schematically showing a "many-to-many" arrangement. Figure 7C shows a non-circular conduit, while Figure 7D shows a circular conduit.
[0039] Figure 8 is Figure 1A and 1B a representation of a container of a medical waste collection system of
[0040] Figure 9 is a representation of a transmitter including light-emitting diodes and an optical waveguide of different wavelengths. Detailed Description
[0041] Figure 1A and 1B show a fluid characterization system 100 for characterizing fluids removed and collected from a patient. System 100 includes a conduit 104, a container 106, a vacuum source 108, and a sensor module 200. Patient fluid removed under the suction of the vacuum source 108 can be aspirated through the conduit 104 and collected in the container 106. As shown, the container 106 and the vacuum source 108 can be integrated in a mobile cart of a medical waste collection system 112, such as those sold under the trademark Neptune by Stryker Corporation (Kalamazoo, Michigan), which are disclosed in co-owned U.S. Patent No. 7,621,898, issued on November 24, 2009, the entire content of which is incorporated herein by reference. By being coupled to the conduit 104, the sensor module 200 can be integrated into a conventional waste management system without substantial equipment addition or modification. For example, the conduit 104 can be coupled upstream of a manifold 114, which is configured to be removably received in a receiver 116 of the medical waste collection system 112. Additionally or alternatively, the conduit 104 can be coupled to a cartridge 118, which is configured to be removably received in a receiver 120 of a console 122. Figure 1A The illustrated embodiment is exemplary, Figure 1B shows a schematic diagram of another system 100, where like numerals represent like components. For example, Figure 1B the container 106 and the vacuum source 108 in
[0042] System 100 includes a sensor module 200 configured to be coupled to a conduit 104. The sensor module 200 includes one or more sensors 230 and / or other measurement devices for detecting one or more optical properties of a fluid flowing through the conduit 104. System 100 may also include at least one processor 110 that communicates electronically with the one or more sensors 230 and receives sensor data from the one or more sensors 230. The processor 110 may be integrated with the sensor module 200 (e.g., within the sensor housing 220), and / or the sensor data may be transmitted via a wireless transceiver 202 of the sensor module 200 to a complementary transceiver on a medical waste collection system 112 and / or a console 122 including the processor 110 or another processor. The processor 110 is configured to execute computer-implemented instructions stored on a non-transitory memory (not shown) to analyze or characterize the fluid. Of interest is determining the fluid composition of the fluid, particularly the blood concentration. Based on the determined blood concentration, the blood loss can be estimated or quantified according to the determined fluid collection amount (or volume) measured by a fluid measurement subsystem within a container 106 of the medical waste collection system 112. Additionally or alternatively, the blood loss can be estimated or quantified based on the determined volumetric flow rate per unit time, which is measured, for example, by an ultrasonic sensor (not shown), a camera, a mass flow sensor, or other electronics of the sensor module 200. The medical waste collection system 112 and the console 122 may include a display 124 for real-time display of the results of the fluid analysis, such as the patient's average or cumulative blood loss.
[0043] Reference Figures 2A - 2C , depicts an exemplary form of the sensor module 200. The sensor module 200 may be coupled to a housing 220 or at least partially disposed within the housing 220, which is configured to couple the sensor module 200 to the conduit 104. Alternatively, at least some of the sensors 230 and other components of the sensor module 200 may be individually coupled to the conduit 104 (e.g., outside of a single common housing). The sensor module 200 may be adjustable or universal such that the housing 220 may be coupled to a variety of types of conduits (e.g., without relying on being coupled to any particular type or brand of conduit).
[0044] The housing 220 may be configured to clamp onto the conduit 104. For example, as Figure 2AAs shown, the housing 220 of the sensor module 200 can include at least a first jaw 222 and a second jaw 224, which are configured together to clamp onto the conduit 104. Each jaw 222, 224 can include at least one conduit seat 226, which is shaped and sized to receive the conduit 104. For example, for a conduit 250 with a circular cross-section, each jaw 222 or 224 can include a semi-circular conduit seat 226. For embodiments where the conduit 250 is non-circular, the conduit seats 226 can together form a rectangle, ellipse, hexagon, octagon, or other suitable geometric shape for accommodating the conduit 250. Additionally, the housing 220 can include three, four, or other appropriate number of jaws, sized and shaped to accommodate non-circular conduits. In an alternative embodiment, the housing 220 can be C-shaped and configured to clamp onto the non-circular conduit 250. One or more of the conduit seats 226 can include a deformable surface, which is configured to compress such that the housing 220 can receive and conform to the non-circular conduit. In yet other variations, the sensor module 200 can be encapsulated with multiple conduit seats 226, each having a different size and shape to accommodate non-circular conduits of different geometries.
[0045] The conduit seat 226 engages the conduit 250 to maintain the relative position of the one or more sensors 230 around the conduit 250. When the housing 220 is clamped onto the conduit 250, the conduit seats 226 together form a lumen defining a longitudinal axis AL, as Figure 2A shown. Thus, the longitudinal axis AL is substantially parallel to the conduit 250, and the sensors 230 can be arranged radially around the longitudinal axis AL and the conduit 250.
[0046] Figure 2B and 2C The sensors 230 generally shown in and can be further defined as an optical emitter 232 and an optical detector 234 as used hereinafter. As their names imply, the optical emitter 232 is configured to emit an optical signal, while the optical detector 234 is configured to detect the optical signal emitted from the optical emitter 232. The detector 234 generates data and transmits it to the processor 110 for characterizing fluid flow (e.g., estimating the velocity of the flow, the mass flow rate of the flow, the volume flow rate of the flow, or any suitable combination thereof), for estimating the concentration of one or more fluid components, or both.
[0047] Existing systems may include emitter-detector pairs, with the emitter of each pair arranged diametrically opposite the corresponding detector with respect to a circular conduit. Thus, for all emitter-detector pairs, the propagation path from the emitter through the conduit to the corresponding detector is the same. As described above, the intensity of the optical signal may be attenuated by the fluid flowing through the conduit, such as blood in the fluid absorbing and / or scattering the optical signal. However, for the sensitivity ranges of most detectors, existing systems are unable to accurately characterize the fluid in procedures where high and low blood concentrations may change rapidly as the fluid is aspirated through conduit 250. For example, a high concentration of blood may cause the optical signal to be too attenuated to be detected by the detector.
[0048] The system 100 of the present disclosure overcomes these drawbacks by providing high dynamic range (HDR) sensing and further providing more robust data to the processor 110. To this end, the sensor module 200 may be coupled to a non-circular conduit, and the emitter and detectors 232, 234 are positioned around the non-circular conduit in a manner to be described.
[0049] Now referring to Figure 3A and 3B , an exemplary non-circular cross-section of conduit 250 is depicted. Conduit 250 includes at least two different side lengths - a first side length L1 and a second side length L2. The longer side length may be referred to as the major cross-sectional dimension, while the shorter side length may be referred to as the minor cross-sectional dimension. In the illustrated embodiment, the first side length L1 is the major cross-sectional dimension, and the second side length L2 is the minor cross-sectional dimension. Conduit 250 may be substantially rectangular, elliptical, or oval, or other suitable geometric shape. Alternatively, conduit 250 may initially be formed with a circular cross-section and be deformed or compressed into a non-circular shape by conduit seat 226. Figure 3A and 3B Schematically illustrate an exemplary positioning of emitter 232 and detector 234 around conduit 250, with the remainder of sensor module 200 omitted for clarity of description.
[0050] Sensor module 200 generally defines two axes, such as a first transverse axis AT1 and a second transverse axis AT2. The transverse axes AT1, AT2 may be perpendicular to each other and perpendicular to the longitudinal axis AL, or may be any two axes that are not parallel to each other and not parallel to the longitudinal axis AL. Figure 3A and Figure 3BThe emitter 232 and the detector 234 in [it] can be arranged at the same axial position along the catheter 250. Alternatively, the respective emitters 232 can be axially spaced apart from each other along the catheter 250 and / or spaced apart relative to the detector 234, in which case the transverse axes AT1 and AT2 may not be perpendicular to the longitudinal axis AL. In addition to the radioactive arrangements disclosed herein, other groups of emitters 232 and detectors 234 axially spaced apart along the catheter 250 may be provided.
[0051] Reference Figure 4A and 4B , depicts a cross-section of the catheter 250 and a representation of the optical signal transmitted from the emitter 232 to the detector 234. The optical signals are shown as a first optical signal S1 and a second optical signal S2. For illustrative purposes, the optical signals S1, S2 are respectively shown as propagating substantially along a first transverse axis AT1 and a second transverse axis AT2, which two transverse axes are substantially parallel to the side lengths L1, L2 of the catheter 250. Thus, the propagation paths of each optical signal S1, S2 have different lengths. The propagation path of the first optical signal L1 is greater than or longer than the propagation path of the second optical signal L2. For example, the propagation path of the first optical signal S1 can be at least 1.25 times, 1.5 times, 2 times or more times the propagation path of the second optical signal S2. Other sizes can be considered according to the aspect ratio of the non-circular catheter 250.
[0052] Due to the different lengths of the propagation paths of the optical signals S1 and S2, multiple benefits can be achieved. First, the sensor module 200 provides HDR sensing to adapt both high and low concentration blood to the sensitivity range of the detector 234. As described above, the fluid content may vary between high and low blood concentrations, causing the optical signal to attenuate due to absorption and / or scattering by the fluid. The operating parameters of the emitter 232 and the detector 234 can be specifically adjusted according to the relative sizes between the first and second propagation paths S1 and S2 so that sufficient light intensity can be detected by at least one of the detectors 234 regardless of the blood concentration in the fluid. More specifically, the light intensity emitted by the emitter 232 (or the gain of the detector 243) can be adjusted or selected according to the different side lengths L1 and L2 such that (i) in the case of high blood concentration (e.g., greater than 95%), the second optical signal S2 propagating along the shorter propagation path is above the lower sensitivity limit of the detector 234 even after being attenuated by the fluid; and (ii) in the case of low blood concentration (e.g., 0%), the first optical signal S1 is below the upper sensitivity limit of the detector 234 even after being attenuated (or not attenuated) by the fluid. Although the inner diameter of the circular catheter can be reduced to maintain sensitivity to high blood concentration, the resulting cross-sectional area of the circular catheter is too small to also be sensitive to low blood concentration. The same is true for wider circular catheters as they remain sensitive to low blood concentration but lose sensitivity to high blood concentration. Using the non-circular catheter 250 overcomes these challenges.
[0053] It is envisioned that the emitter 232 can emit optical signals of different intensities, and / or the detector 234 can have different sensitivity ranges. For example, the first emitter 232A configured to emit the first optical signal S1 along the longer propagation path may emit a brighter second optical signal S2 than the second emitter 232B. As another example, the first detector 234A configured to detect the first optical signal S1 along the longer propagation path may be more sensitive than the second detector 234B.
[0054] The detector 234 detects the optical signal and generates a data or signal value. The signal value is transmitted to the processor 110, which can determine the concentration of the fluid component, such as the hemoglobin concentration, therefrom. Thus, an exemplary method can include: using the first emitter 232A to transmit the first optical signal S1 along the first axis AT1 through the non-circular catheter 250 and the fluid, and using the first detector 234A to detect the first optical signal S1. The first optical signal S1 may be at least partially absorbed and / or scattered by the fluid. Similarly, using the second emitter 232B to transmit the second optical signal S2 along the second axis AT2 through the non-circular catheter 250 and being detected by the second detector 234B. The second optical signal S2 may be at least partially absorbed and / or scattered by the fluid.
[0055] In some embodiments, a second optical signal S2 is transmitted after the first optical signal S1 is transmitted such that only one of the first transmitter 232A and the second transmitter 232B is operated, activated, or "triggered" at a time. In other words, the first and second optical signals may be triggered in an alternating manner. The alternating triggering may be performed continuously and repeatedly during operation of the system, or in response to a determined condition, or a combination of both. In one example, the alternating triggering may be performed at fixed or variable time intervals. As another example, one of the first and second transmitters 232A, 232B may be triggered at a first fixed time interval, while the other is triggered at a second time interval different from the first fixed time interval.
[0056] In some embodiments, only one of the first and second transmitters 232A, 232B is repeatedly triggered while the other transmitter is in an "idle" state. The other transmitter is triggered only in response to the processor 110 determining a lack of an optical signal or the detector 234 sensing another detectable feature. For example, the first transmitter 232A may be triggered at fixed or variable time intervals, and the first detector 234A detects the first optical signal S1. The processor 110 may compare the first optical signal S1 with a predetermined sensor sensitivity threshold. If the processor 110 determines that the first optical signal S1 has dropped below the sensor sensitivity threshold (e.g., if the first detector 234A does not detect the first optical signal S1), then the processor 110 may operate the second transmitter 232B to begin triggering at fixed or variable time intervals to compensate. The sensor sensitivity threshold may be an instantaneous threshold or may be an average threshold over a predetermined time period (e.g., three seconds). In this regard, the system 100 may compensate in real time for significantly fluctuating blood concentrations in the fluid.
[0057] In some embodiments, the first transmitter 232A may transmit a first optical signal S1 of a first wavelength, while the second transmitter 232B may transmit a second optical signal S2 of a second wavelength. The second wavelength is different from the first wavelength. For example, the first transmitter may be an infrared light-emitting diode (LED), and the second transmitter may be a visible light LED, such as a green LED. The infrared LED may be configured to emit light having a wavelength in the range of approximately 700 nanometers (nm) to 1000 nm, more specifically in the range of 750 nm to 850 nm, and even more specifically in the range of 770 nm to 810 nm. The visible light LED may be configured to emit light having a wavelength in the range of approximately 400 nm to 600 nm, more specifically in the range of 550 nm to 600 nm, and even more specifically in the range of 570 nm to 580 nm.
[0058] It is understood that light of lower wavelengths is more prone to scattering than light of higher wavelengths. Therefore, it can be challenging to detect light of higher wavelengths at greater distances. The sensor module 200 addresses these issues by correlating the wavelengths of the emitters 232 with the different side lengths L1, L2 of the conduit 250 (via the sensor housing 220). More specifically, for example, LEDs of lower wavelengths can be placed across the narrower side length L2 of the conduit 250, while LEDs of higher wavelengths can be placed across the wider side length L1 of the conduit 250. Thus, the optical signals S1, S2 can include light of different frequencies, and the processor 110 can characterize the fluid contents based on the effect of the fluid contents on light of different frequencies (e.g., via the Beer-Lambert law). In other words, the processor 110 can be configured to correlate signal values with the wavelengths of the optical signals S1, S2, which provides more robust data based on which the fluid contents can be characterized using algorithms implemented by the processor 110.
[0059] In addition to absorption of the optical signals, the optical signals can also be scattered by particles in the fluid. For example, referring to Figure 6 , the optical signals S1, S2 are shown passing through exemplary particles of the fluid flowing through the conduit 250. First and second scattered signals SS1, SS2 corresponding to each of the optical signals S1, S2 are shown in the figure. The scattered signals SS1, SS2 are produced by a portion of the respective signals S1, S2 being scattered by the particles. The detector 234 can be configured to receive one of the optical signals S1, S2 and one of the scattered signals SS1, SS2. More specifically, the second detector 234B can receive the first scattered signal SS1 (in addition to the second optical signal S2), and the first detector 234A can receive the second scattered signal SS2 (in addition to the first optical signal S2). These optical signals S1, S2 and scattered signals SS1, SS2 can be correlated to different wavelengths (and / or the trigger timing of the emitter 232) such that the processor 110 is configured to detect whether the received signal is an optical signal or a scattered signal. The signal values of the signals S1, S2, SS1, SS2 received by the respective detectors 234 can be transmitted to the processor 110 to provide a more comprehensive data matrix. The processor 110 can be configured to determine the fluid characteristics of the fluid contents based on the optical signals S1, S2 received by the respective first and second detectors 234A, 234B and the scattered signals SS1, SS2 received by the respective second and first detectors 234B, 234A. Thus, an exemplary method can include generating, by the second detector 232B, a first scattered light value SS1 indicative of at least partial scattering of the first optical signal S1 by the fluid. A second scattered light value SS2 indicative of at least partial scattering of the second optical signal S2 by the fluid is produced by the first detector 234A. The processor 110 further determines the fluid composition based on the first scattered light value SS1 and the second scattered light value SS2.
[0060] Additionally or alternatively, the optical signals S1, S2 can be used to determine the fill level within the conduit 250. For illustrative purposes, Figure 3A and 3B the first transverse axis AT1 can be oriented perpendicular to gravity, while the second transverse axis AT2 can be oriented parallel to gravity. Further referring to Figure 5A and 5B , the conduit 250 is shown as being partially filled with fluid at different levels, according to the shaded portion of the conduit 250. It should be understood that at higher suction levels of the vacuum source 108, the fluid may not actually "settle" in the lower portion of the conduit 250. However, even within the very irregular flow path through the conduit 250, the optical signals S1, S2 may still be attenuated and scattered such that the principles herein still apply. Starting from Figure 5A , since the fill level is above the propagation path of the second optical signal S2, the second optical signal S2 may be attenuated accordingly. The processor 110 can be configured to correlate the respective data from the first and second detectors 234A, 234B to estimate the fill level. On the other hand, Figure 5B shows a lower fill level where there is little to almost no attenuation of the second optical signal S2 (and the attenuation of the first optical signal S1 is relatively small compared to Figure 5A ). Similarly, the fluid characterization algorithm run by the processor 110 can be configured to correlate the respective data from the first and second detectors 234A, 234B to estimate the fill level. In embodiments where additional transmitters 232 and detectors 234 are provided around the conduit 250 (see Figures 7A - 7D ), the additional data (e.g., attenuation and scattering data) from the combination of each detector 234 and each transmitter 232 can provide a data-rich matrix for the processor 110 to determine the proportion of the conduit 250 filled with fluid.
[0061] The previous embodiments described herein include two transmitter-detector pairs (i.e., 232A - 234A and 232B - 234B). In an exemplary embodiment, the sensor module 200 can include more than two transmitters 232 and more than two detectors 234. The transmitters 232 and detectors 234 of the sensor module 200 can include three, four, six (see Figure 3A , 3B and 7A - 7D), ten or more, respectively. It is further contemplated that the sensor module 200 can include more transmitters 232 than detectors 234, or more detectors 234 than transmitters 232. Figures 7A - 7D Shows an exemplary arrangement of the transmitter 232 and detector 234, where various optical signals and scattered signals transmitted through the conduit and fluid (removed for clarity) are shown. For clarity, not all optical signals and scattered signals are shown.
[0062] Reference Figure 7A depicts a "one-to-many" arrangement in which a source transmitter 232O emits an optical signal configured to be received by more than one detector 234. The source transmitter 232O can be configured to emit optical signals that are respectively directed to specific detectors 234. For example, the source transmitter 232O can be configured to emit optical signals of multiple optical wavelengths, and each detector 234 can be configured to receive light of one of the multiple wavelengths. Alternatively, the source transmitter 232O can be configured to emit an optical signal that is configured to be received by all detectors 234 in a nearly simultaneous manner.
[0063] From Figure 7A it can be seen that the propagation paths between the transmitter 232 and most or all of the detectors 234 are different. In addition, the detectors 234 are arranged at different angles relative to each transmitter 232. For example, the source transmitter 232O emits optical signals received by different detectors 234B, 234C, 234D, 234E. Two detectors 234C, 234D arranged opposite to the source transmitter 232O effectively measure the absorbance of the optical signal through the entire fluid. In contrast, two detectors 234B, 234E measure the absorbance of the optical signal passing through a shorter propagation path. In addition, the scattered signal SS is also detected by the detectors 234. In this case, an array D of sensor data collected at fixed intervals (in the region of hundreds of hertz to capture changes in fluid flow) can be represented as:
[0064]
[0065] where Si is the signal from the transmitter 232 received by the detector 234, and y is the number of detectors 234. Alternatively, the above concept can be applied to embodiments having a single transmitter 232 and multiple detectors 234.
[0066] Thus, certain exemplary methods can include repeatedly transmitting an optical signal through a conduit 250 and a fluid using a transmitter 232. Detecting, using each of a first and a second detector 234, an optical signal that is at least partially absorbed and scattered by the fluid. The transmitter 232 and the first and second detectors 234 are arranged in an array around the conduit 250 such that the distances between the transmitter and each of the first and second detectors are different. A processor determines an absorbance value and a scatter value for each of a first and a second optical signal based on data from each of the first and second detectors. The processor 110 determines the concentration of the fluid components in the fluid based on the absorbance value and the scatter value.
[0067] See Figure 7B, the figure depicts a "many-to-one" arrangement in which multiple transmitters 232 each emit an optical signal that is received by the same receiving detector 234R. In this many-to-one arrangement, the receiving detector 234R can be configured to receive light of multiple wavelengths, while the transmitters 232 can be configured to each emit an optical signal corresponding to a specific wavelength. Alternatively, each transmitter 232 can be configured to transmit an optical signal at different times. The processor 110 is configured to associate the signal value from the receiving detector 234R at a specific time with a single transmitter 232.
[0068] Reference Figure 7C and 7D , the figure depicts a "many-to-many" arrangement in which multiple transmitters 232A - 232F each emit multiple optical signals that are received by each of multiple detectors 234A - 234F. These optical signals can be distinguished according to wavelength, time, or any other signal characteristic. Thus, this combination of (multiple) light sources and (multiple) sensors provides an exemplary rich data array of absorbance and scattering information of light from multiple wavelengths. In other words, the arrangement can include a combination of all transmitter-detector pairs that provide signal values of the (multiple) optical signals, and a combination of all transmitter-detector pairs that provide another signal value of the (multiple) scattering signals. For example, each transmitter 232 can be illuminated in sequence, and each detector 234 measures the absorbance and scattering from that transmitter 232. For example, where Si corresponds to the ith signal received by the ith detector 234, and Li corresponds to the ith source transmitter 232, the pattern starts with L1 being illuminated and measurements being recorded from S1, S2, etc. up to S5. Then L1 is deactivated, L2 is illuminated, and measurements are recorded again from all sensors. This sequence continues until each light source has been illuminated and sensor data has been recorded. Once all light sources have been illuminated, the sequence starts over from the first light source. The sequence repeats at regular intervals in the region of hundreds of hertz in order to update changes in fluid flow in a timely manner. Each iteration of the sequence generates a data matrix D':
[0069]
[0070] where Li is the corresponding transmitter (e.g., 232A - 232F), Si is the detector (e.g., 234A - 234F), x is the number of transmitters, and y is the number of detectors 234. The data matrix can contain columns corresponding to the detectors 234 and rows corresponding to the transmitters 232. For example, the first column of data can include the signal intensities received by each detector 234 associated with the first transmitter 232. Additionally, the first row of data can include the signal intensities of the signals received by one of the detectors 234 from each transmitter 232.
[0071] An enriched data matrix is provided to the processor 110 and utilized to characterize the fluid contents flowing through the conduit 250. In other words, the processor 110 can perform mathematical operations on the enriched data matrix to characterize the fluid contents. A model (such as a neural network, Gaussian regression model, or other machine learning model) trained using representative test data can use this information matrix to determine the characteristics (such as blood concentration) of the fluid within the tube at each time interval. The processor 110 can determine the concentration from the absorbance by the Beer-Lambert law, which states that there is a linear relationship between the absorbance of a solution and its concentration. It can be understood that the optical signal may have other, different signal characteristics. The signal characteristics can be provided as additional data to the processor 110 for characterizing the fluid contents. Additionally, it should be understood that the Figures 7A - 7D described embodiments of multivariate analysis can be used for conduits with non-circular cross-sections ( Figures 7A - 7C ) or conduits with circular cross-sections ( Figure 7D ).
[0072] Accordingly, certain exemplary methods can include: transmitting a first optical signal through the conduit and the fluid using a first emitter; transmitting a second optical signal through the conduit and the fluid using a second emitter; detecting, using each of the first and second detectors, the first and second optical signals that are at least partially absorbed and scattered by the fluid, wherein the first and second emitters and the first and second detectors are arranged in an array around the conduit such that the distances between each combination of the first and second emitters and the first and second detectors are different; determining, using a processor, absorbance values and scattering values of the first and second optical signals based on data from each of the first and second detectors to provide a data matrix; and determining, using the processor, the concentration of the fluid component in the fluid based on the data matrix of absorbance values and scattering values.
[0073] By illuminating the emitters 232 in different orders, patterns, groupings, etc., more information can be added to the matrix. In one example, the emitters 232 are activated sequentially, one at a time, in an order arranged according to their positions around the catheter (e.g., clockwise or counterclockwise). In another example, a first subset of the emitters 232 is activated in combination, and then a second subset of the emitters 232 is activated. The emitters 232 can also illuminate at a specific frequency - the frequency can be applicable to any illumination pattern. For example, the emitters 232 can illuminate at regular intervals, e.g., in the region of hundreds of Hertz. Each illumination iteration can provide the processor 110 with a rich data matrix for characterizing the fluid contents. The timing of the optical signals can also be controlled by the processor 110 based on the data received from the detectors 234. For example, the processor 110 can cause a first optical signal S1 to be emitted at a first time and a second optical signal S2 to be emitted at a second time only if the first optical signal S1 is not received by the detector 234, so that sufficient information is provided to the processor 110 to characterize the fluid contents. More specifically, the processor 110 can determine the signal strength of the first optical signal S1 received by one of the detectors 234 and compare the signal strength with a sensor sensitivity threshold, where the sensor sensitivity threshold corresponds to the minimum signal strength required to characterize the fluid contents. If the first optical signal S1 with a signal strength higher than the sensor sensitivity threshold is not received, the second optical signal S2 can be emitted. This process can be repeated until the processor 110 has sufficient information to accurately characterize the fluid contents flowing through the catheter 250. In this regard, since the propagation paths between various combinations of the emitters 232 and the detectors 234 are partially or completely different, these embodiments also provide HDR sensing.
[0074] Then the sensor data can be provided to the processor 110, and the processor 110 can run a fluid characterization algorithm or model trained with representative test data, such as a neural network, a Gaussian regression model, a parametric model, or other machine learning models. In an exemplary embodiment, the fluid characterization algorithm is a parametric model based on a dataset machine-trained on one or more neural networks. For example, artificial intelligence can employ a parametric model to determine which characteristics of the fluid contents are related to the signal values of several detectors 234. More specifically, based on the known relationship between blood concentration and the effect of certain blood concentrations on optical signals, the processor 110 can characterize the fluid contents as having a specific blood concentration. In another example, the processor 110 is able to have access to the known relationship between signal attenuation and material properties to characterize the fluid contents. In another example, the processor 110 is able to have access to the known relationship between signal timing and material properties to characterize the fluid contents. These relationships can be used alone or in combination. The known relationships can be established by training a parametric model (or other machine learning model) with training data. Once the processor 110 is able to have access to these known relationships, the processor 110 can characterize the fluid contents by providing signal emission and signal detection characteristics (and other characteristics described herein) as inputs to the parametric model.
[0075] In another embodiment, the fluid characterization algorithm may include algorithm modules disclosed in co-owned U.S. Patent Publication No. 2022 / 0008637, published on January 13, 2022, the entire content of which is incorporated herein by reference. The fluid characterization algorithm may include a feature extraction module that takes a digital signal as input from a processor and returns a set of digital signals representative of one or more unique features of the fluid for algorithmic analysis. When there are no strong features to track during fluid flow (e.g., during laminar or continuous fluid flow regions), the fluid motion model module may estimate the flow of the fluid contents. The fluid characterization algorithm may also include an optical quality estimation module for analyzing a measured substance in the fluid contents when the fluid contents pass through a conduit paired with a sensor module with a detector. The fluid scatter estimation module may determine the presence of scatter particles, which may be performed as part of estimating the hemoglobin concentration in blood at different hemolysis levels that cause changes in the scatter parameter. The fluid characterization algorithm may also include a fluid type classification module for classifying the fluid contents within a given time frame (e.g., determining the fluid type of the fluid contents). The fluid type classification module automatically classifies different fluid contents with different characteristics based on the output of the sensor module or other measurement modalities. The sensor fusion module may combine measurements of the measured substance between different sensors (e.g., using different measurement modalities or using different emitter-detector arrangements). Additionally or alternatively, the processor 110 may utilize known relationships between signal attenuation and material properties to characterize the fluid contents. For example, the processor 110 may use the Beer-Lambert law to characterize the fluid contents based on the wavelength of the optical signal and the attenuation of the signal, the attenuation being known based on the intensity of the optical signal received by one of the detectors 234. The processor 110 may also / alternatively perform other forms of spectral analysis. For example, the processor 110 may perform spectral analysis as described in the aforementioned U.S. Patent Publication No. 2022 / 0008637. Other mathematical phenomena are also contemplated.
[0076] Now refer to Figure 8, alternative embodiments are provided where the sensor module 200 is coupled to a container 106, such as the container 106 of a medical waste collection system 112. The sensor module 200 is shown as having a single emitter 232 and a single detector 234 arranged adjacent to the emitter 232, but more than one emitter or detector may be provided. The sensor module 200 is coupled to the outer wall of the container 106 and is located outside the volume space defined by the container 106. The arrangement of the emitter 232 and the detector 234 (e.g., adjacent to each other and positioned adjacent to the outer wall) is configured to enable reflection spectroscopy. In this embodiment, an optical signal is directed into the fluid contents within the container 106, where some of the light is absorbed and some is reflected. As shown, a first optical signal S1 is emitted into the container 106, and a first scattered signal SS1 is reflected back towards the detector 234. The processor 110 can utilize an analysis of the amount of absorbed and scattered light, such as received by the detector 234, to characterize the fluid contents. More specifically, the first scattered signal SS1 can include light of multiple wavelengths, and the intensity of each wavelength received by the detector 234 corresponds to the absorbance and reflection spectrum of the fluid contents. If the fluid contents contain a known substance, such as blood, the processor 110 can consider the absorbance and reflection spectrum of the known substance in order to determine the concentration of the known substance according to the algorithms disclosed herein.
[0077] When the fluid in the container 106 has high absorbance and scattering characteristics (e.g., a high concentration of blood), or when the container 106 is too wide for the optical signal from the sensor module 200 to traverse, Figure 8 the reflection spectroscopy embodiment may be useful. Since the optical signal emitted into the container 106 may be completely absorbed and / or scattered by the fluid contents before traversing the entire container, the detector 234 can be placed close to the emitter 232 to receive the scattered portion of the optical signal (e.g., the first scattered signal SS1 from the first signal S1). The processor 110 can use the scattered signal SS1 received by the detector 234 to characterize the fluid contents according to any of the methods described herein.
[0078] Figure 9An embodiment of the emitter 232 is shown. In cases where the fluid contents are highly heterogeneous, the fluid may contain patient fluid (e.g., blood) at high and low concentrations. The emitter 232 includes an optical waveguide 240 disposed between a source emitter 232O and a plurality of LEDs 232A, 232B, 232C. The LEDs 232A, 232B, 232C may have different wavelengths. For example, the first LED 232A may be blue, the second LED 232B may be green, and the third LED 232C may be red. More than three LEDs may be provided, and other colors may be considered. The LEDs 232A, 232B, 232C may be activated simultaneously or sequentially. A particular advantage is that different wavelengths are output from the same location (i.e., the source emitter 232O). In this way, although the wavelengths of the optical signals are different, their propagation paths in the fluid are the same. The absorbance and / or scattering characteristics of the fluid contents can be more accurately determined by the processor 110, for example, by eliminating the situation where different sources cause optical signals to pass through high and low concentration blood "holes" in the fluid within the highly heterogeneous fluid. It should be understood that Figure 9 the emitter 232 of Figure 9 can be implemented as any one or more of the emitters 232 of other embodiments disclosed herein.
[0079] Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terms used are intended as descriptive rather than restrictive terms. Many modifications and variations can be made in accordance with the above teachings, and the invention can be practiced in a manner different from that specifically described. Although the foregoing description mostly relates to blood concentration, it should be understood that the sensor module 200 and its related methods can be used to characterize fluid contents based on any fluid passing through the catheter 250. For example, when the fluid is a more complex mixture, such as blood, absorbance and light scattering exist due to the presence of cells, and the multidimensional data in the rich data matrix (D′) may help determine other composite variables, such as the level of hemolysis in the blood (i.e., the situation where cells rupture and their contents leak into the solution). This varying characteristic of blood may make it difficult for existing systems using a single emitter-detector pair to determine its concentration.
[0080] Exemplary systems for implementing the methods described herein may include a computing device (e.g., a smartphone, a tablet, or a wearable device) that includes a processor 110 and a memory. As used herein, the term "memory" refers to a machine-readable medium capable of storing data temporarily or permanently and can be used to include, but is not limited to, random access memory (RAM), read-only memory (ROM), buffer memory, flash memory, and cache memory. The term "machine-readable medium" should also include any medium or combination of media capable of carrying (e.g., storing or transmitting) instructions executable by a machine such that the instructions, when executed by one or more processors (e.g., the processor) of system 100, cause the machine to perform any one or more of the methods described herein (in whole or in part). Thus, the term "machine-readable medium" should be understood to include, but is not limited to, one or more tangible and non-transitory data repositories (e.g., data volumes). The "non-transitory" machine-readable medium used herein expressly excludes the propagated signal itself.
[0081] The various operations of the example methods described herein may be performed, at least in part, by one or more processors temporarily configured (e.g., by software) or permanently configured to perform the associated operations. Additionally, such one or more processors may perform the operations in a "cloud computing" environment or as a service (e.g., in a "software as a service" (SaaS) implementation). At least some of the operations in any one or more of the methods discussed herein may be performed by a group of computers (e.g., as an example of a machine including processors) that are accessible via a network (e.g., the Internet) and via one or more appropriate interfaces (e.g., application programming interfaces (APIs)). These and other variations, modifications, additions, and improvements are within the scope of the subject matter of this disclosure.
[0082] Other inventive aspects are disclosed in the following exemplary clauses.
[0083] Clause 1 - A medical waste collection system, comprising: a vacuum pump; a container in fluid communication with the vacuum pump and including an outer wall, wherein the container is configured to collect fluid under the influence of the suction of the vacuum pump; a sensor module including a housing, a transmitter, and a detector, wherein the transmitter and the detector are positioned adjacent to the outer wall and outside the container, wherein the transmitter is configured to emit an optical signal and the detector is configured to detect the optical signal absorbed and / or scattered by the fluid within the container; and a processor in electronic communication with the sensor module and configured to receive sensor data from the detector and characterize the fluid composition of the fluid.
[0084] Clause 2 - A sensor module for characterizing a fluid from a patient, the sensor module comprising: a housing configured to be coupled to a non-circular conduit, the housing including: a first conduit seat arranged to be positioned adjacent to one side of the non-circular conduit when the housing is coupled to the non-circular conduit; a second conduit seat arranged to be positioned adjacent to an opposite side of the non-circular conduit when the housing is coupled to the non-circular conduit, and a lumen defined by the first and second conduit seats when the housing is coupled to the non-circular conduit, the lumen including: a smaller cross-sectional dimension, and a larger cross-sectional dimension greater than the smaller cross-sectional dimension; a first light-emitting diode coupled to the housing and configured to output an optical signal of a first wavelength; a second light-emitting diode coupled to the housing and configured to output an optical signal of a second wavelength different from the first wavelength; a first detector coupled to the housing opposite the first light-emitting diode with respect to the smaller cross-sectional dimension, the first detector being configured to detect the optical signal of the first wavelength from the first light-emitting diode and the scattered optical signal of the second wavelength from the second light-emitting diode; a second detector coupled to the housing opposite the second light-emitting diode with respect to the larger cross-sectional dimension and configured to detect the optical signal of the second wavelength from the second light-emitting diode and the scattered optical signal of the first wavelength from the first light-emitting diode.
[0085] Clause 3 - The sensor module according to Clause 2, further comprising a processor in communication with at least one of the first light-emitting diode, the second light-emitting diode, the first detector, and the second detector.
[0086] Clause 4 - The sensor module according to Clause 3, wherein the processor is configured to determine the concentration of the fluid components of the fluid flowing through the non-circular conduit based on the optical signals detected by the first and second detectors and the scattered optical signals detected by the first and second detectors.
[0087] Clause 5 - The sensor module according to Clause 4, wherein the processor is further configured to determine the concentration of the fluid components of the fluid flowing through the non-circular conduit by analyzing the optical signals and the scattered optical signals using a parametric model generated by a machine-trained neural network.
[0088] Clause 6 - The sensor module according to Clause 3, wherein the processor is further configured to: determine an absorbance value and a scatter value for each of the first optical signal, the second optical signal, and the scattered optical signal according to the data from each of the first and second optical detectors to provide a data matrix; and determine the concentration of the fluid components in the fluid flowing through the non-circular conduit based on the data matrix of the absorbance values and the scatter values.
[0089] Clause 7 - An optical emitter for use with a sensor module to characterize a fluid from a patient, the optical emitter comprising: a source emitter configured to output optical signals of a plurality of wavelengths; a first light emitting diode configured to output an optical signal of a first wavelength of the plurality of wavelengths; a second light emitting diode configured to output an optical signal of a second wavelength of the plurality of wavelengths; and an optical waveguide coupling each of the first and second light emitting diodes to the source emitter.
Claims
1. A method of characterizing a fluid flowing through a non-circular conduit using a system including a first and a second optical emitter, a first and a second optical detector, and a processor, the method comprising: Transmitting a first optical signal along a first axis through the non-circular conduit and the fluid using the first optical emitter; Detecting the first optical signal at least partially absorbed by the fluid using the first optical detector; Transmitting a second optical signal along a second axis different from the first axis through the non-circular conduit using the second optical emitter such that a relative path of one of the first and second optical signals through the non-circular conduit is shorter than the other; Detecting the second optical signal at least partially absorbed by the fluid using the second optical detector; And Determining a concentration of a fluid component in the fluid based on the first and second optical signals using the processor.
2. The method according to claim 1, wherein the first axis and the second axis are perpendicular to each other.
3. The method according to claim 1 or 2, wherein the first axis and the second axis are transverse to a longitudinal axis of the non-circular conduit.
4. The method according to claim 3, wherein the first and second axes correspond to respective ones of a larger cross-sectional dimension and a smaller cross-sectional dimension of the non-circular conduit.
5. The method according to any one of claims 1-4, wherein the non-circular conduit is at least one of an ellipse, an oval, a hexagon, an octagon, and a rectangle.
6. The method according to any one of claims 1-5, wherein the step of transmitting the second optical signal is performed after the step of transmitting the first optical signal such that only a single one of the first optical emitter and the second optical emitter is operating at a time.
7. The method according to any one of claims 1-6, further comprising alternating transmission between the first optical signal and the second optical signal.
8. The method according to claim 7, wherein the step of alternating transmission between the first optical signal and the second optical signal is performed continuously and repeatedly during operation of the system.
9. The method according to claim 6, further comprising: Comparing the first optical signal with a sensor sensitivity threshold using the processor; and Responsive to the first optical signal being below the sensor sensitivity threshold, performing the step of transmitting the second optical signal.
10. The method according to any one of claims 1-9, wherein the step of determining the concentration of the fluid component further comprises analyzing the first and second optical signals using a parametric model generated by a neural network trained by a machine.
11. The method according to any one of claims 1-10, further comprising: Generating a first scattered light value using the processor, the first scattered light value indicating the first optical signal at least partially scattered by the fluid detected by the second optical detector; Generating a second scattered light value using the processor, the second scattered light value indicating the second optical signal at least partially scattered by the fluid detected by the first optical detector; And Determining the concentration of the fluid component further based on the first and second scattered light values using the processor.
12. A method of characterizing a fluid flowing through a conduit using a system including a first and a second optical emitter, a first and a second optical detector, and a processor, the method comprising: Repeatedly transmitting an optical signal through a conduit and a fluid using an optical transmitter; Detecting the optical signal at least partially absorbed and scattered by the fluid using each of a first and a second optical detector, wherein the first and second optical transmitters and the first and second optical detectors are arranged around the conduit in an array such that the distances between the optical transmitter and each of the first and second optical detectors are different; Determining an absorbance value and a scatter value for each optical signal in the optical signals detected by each of the first and second optical detectors using a processor; And Determining the concentration of the fluid components in the fluid based on the absorbance value and the scatter value using a processor.
13. A method for characterizing a fluid flowing through a conduit using a system including a first and a second optical transmitter, a first and a second optical detector, and a processor, the method comprising: Transmitting a first optical signal through the conduit and the fluid using the first optical transmitter; Transmitting a second optical signal through the conduit and the fluid using the second optical transmitter; Detecting the first and second optical signals at least partially absorbed and scattered by the fluid using each of the first and second optical detectors, wherein the first and second optical transmitters and the first and second optical detectors are arranged around the conduit in an array such that the distances between each combination of the first and second optical transmitters and the first and second optical detectors are different; Determining an absorbance value and a scatter value for each of the first and second optical signals according to data from each of the first and second optical detectors using a processor to provide a data matrix; And Determining the concentration of the fluid components in the fluid based on the data matrix of the absorbance value and the scatter value using a processor.
14. The method according to claim 13, further comprising: Transmitting the first optical signal at a first wavelength; And Transmitting the second optical signal at a second wavelength different from the first wavelength.
15. The method according to claim 13 or 14, wherein the step of transmitting the second optical signal is performed after the step of transmitting the first optical signal such that only a single one of the first optical transmitter and the second optical transmitter is operating at a time.
16. The method according to any one of claims 13 - 15, further comprising alternating transmission between the first optical signal and the second optical signal.
17. The method according to claim 16, wherein the step of alternating transmission between the first optical signal and the second optical signal is continuously and repeatedly performed during operation of the system.
18. A method for characterizing a fluid flowing through a conduit using a system including an optical transmitter arranged around the conduit in an array, an optical detector arranged around the conduit in an array, and a processor, the method comprising: Transmitting an optical signal through the conduit and the fluid using the optical transmitter, wherein the optical transmitters are activated one by one in the order of their positions around the conduit; Detecting the optical signal at least partially absorbed and scattered by the fluid using the optical detector; Determining an absorbance value and a scatter value for each optical signal in the optical signals according to data from the optical detector using a processor; And Determining the concentration of the fluid components in the fluid based on the absorbance value and the scatter value using a processor.
19. The method according to claim 18, wherein each optical transmitter and each optical detector are arranged around the catheter in an array such that the distances between each combination of the optical transmitter and the optical detector are different.
20. A method of characterizing a fluid flowing through a catheter using a system, the system including an optical transmitter arranged around the catheter in an array, an optical detector arranged around the catheter in an array, and a processor, the method including: transmitting a light signal through the catheter and the fluid using a first optical transmitter among the optical transmitters; detecting, using an optical detector that is adjacent to or closest to the first optical transmitter among the optical detectors, the light signal that is at least partially absorbed and scattered by the fluid; determining, using the processor, an absorbance value and a scattering value for each light signal in the light signals based on data from the optical detector; and determining, using the processor, the concentration of the fluid components in the fluid based on the absorbance value and the scattering value.
21. The method according to any one of claims 14-20, wherein the step of determining the concentration of the fluid components further includes analyzing the first and second light signals using a parametric model generated by a neural network trained by a machine.
22. The method according to any one of claims 14-21, wherein the catheter is non-circular, and optionally wherein the non-circular catheter is at least one of oval, ovoid, and rectangular.
23. The method according to any one of claims 14-22, wherein each optical transmitter and each optical detector are coupled to the outer diameter of the catheter to form a ring.
24. The method according to claim 23, wherein each optical detector is arranged at a different angle relative to each optical transmitter.
25. The method according to any one of claims 1-24, further including displaying the concentration of the fluid components on a display.
26. A system, including: a sensor module; a processor that is in electronic communication with the sensor module and is configured to characterize a fluid flowing through a catheter according to the method of any one of claims 1-25; and, optionally, a display that is in electronic communication with the processor and is configured to display an analysis of the characterization of the fluid.
27. A non-transitory computer-readable medium storing instructions that can be run on one or more processors to execute the method of any one of claims 1-25.
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