Using medical waste collection systems to quantify blood loss

Abstract

Blood loss is quantified using a medical waste collection system, which includes a receiver removably coupled to a manifold. The manifold and / or the medical waste collection system is coupled to a fluid characterization module having sensor components to detect features representing the blood concentration within the fluid. The sensor components may include an emitter and a sensor to detect light transmitted and scattered by the fluid in a suction path or detection window. The first emitter may be a visible light LED, and the second emitter may be an infrared LED. A flow guide may provide a tortuous path within the manifold and facilitate the separation of gas and liquid within the fluid. Quantifying blood loss may include determining the blood concentration within the fluid and determining the volume of fluid collected. The sensor gain may be adjusted based on the transmittance of the collected fluid.

Description

[0001] Priority requirements

[0002] This application claims priority and all benefits to U.S. Provisional Patent Application No. 63 / 112,382, filed November 11, 2020, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Some surgical procedures produce liquid, semi-solid, and / or solid waste as byproducts. Liquid waste may include bodily fluids and irrigation solutions from the surgical site, while solid and semi-solid waste may include tissue blocks and surgical material blocks. Regardless of their state, medical waste is preferably collected so that it neither contaminates the surgical site nor becomes a biohazard in the medical suite where the surgery was performed.

[0004] Medical waste can be removed from the surgical site via a suction tube under the influence of a vacuum provided by the medical waste collection system. An exemplary medical waste collection system is sold by Stryker Corporation (Karamazoo, Michigan) under the trademark name Neptune. Certain forms of this system are disclosed in U.S. Patent Publication No. 2005 / 0171495, published August 4, 2005; International Publication No. WO2007 / 070570, published June 21, 2007; and International Publication No. WO 2014 / 066337, published May 1, 2014, the entire contents of each of which are incorporated herein by reference. A manifold may be provided to facilitate connection of the suction tube to the medical waste collection system via an interface. This manifold may be disposable.

[0005] Collected fluid waste may include blood, which may be in the aspiration path along with other bodily fluids such as interstitial fluid and mucus. Determining the amount of blood loss during surgery can be used to monitor the patient's health. Excessive blood loss may indicate surgical complications, and determining the amount of blood loss helps assess transfusion needs. Of particular interest is childbirth, where obstetric hemorrhage is a leading cause of maternal morbidity—reportedly, 11% of maternal deaths in the United States are due to postpartum hemorrhage. Early detection of obstetric hemorrhage can significantly reduce maternal morbidity. Clinicians and administrators are increasingly advocating for increased use and accuracy of methods and tools for quantifying blood loss, especially for vaginal deliveries and cesarean sections, where postpartum hemorrhage is a critical issue.

[0006] It is known that blood loss during surgery is estimated by visually inspecting absorbent materials (e.g., sponges, surgical gowns, bedding, or curtains), measuring absorbent materials with a scale, and / or by using graduated collection containers under the operating table. Alternatively, the estimation of blood loss may include visually observing the color of the blood and non-blood mixture in a waste container after aspiration from the surgical site.

[0007] The methods described above offer suboptimal accuracy, and there may be a significant delay between determining the amount of blood loss and the blood loss itself. Therefore, it is desirable to provide improved systems, devices, and methods to quantify blood loss during surgical procedures accurately and rapidly. Summary of the Invention

[0008] While the scope of this invention is defined by the claims and terms included herein and without limiting the effects of the invention, this disclosure relates to performing quantitative blood loss analysis using a medical waste collection system and / or manifold. The medical waste collection system includes at least one waste container defining a waste volume for collecting and storing waste. A vacuum source is configured to apply suction to the waste container. A control panel communicates with a controller, including a processor. The controller is configured to operate a vacuum regulator to adjust the vacuum level in the waste container. The medical waste collection system includes at least one receiver sized to removably receive at least a portion of the manifold.

[0009] A fluid characterization module is configured to facilitate the quantification of blood concentration within fluid extracted through a medical waste collection system under suction. The fluid characterization module includes a sensor assembly and may also include a module housing. The fluid characterization module may be free-floating and coupled to an adapter, or integrated with a receiver. The sensor assembly includes a transmitter and a sensor. The transmitter is configured to emit energy, and the sensor is configured to detect the emitted energy. The transmitter may be a light-emitting diode (LED), and the sensor is a photodetector. The transmitter and sensor may be configured to be positioned relative to a detection window. The first transmitter may be an infrared LED, and the second transmitter may be a visible light LED. The infrared LED may be configured to emit light with wavelengths generally in the range of 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. Visible LEDs can be configured to emit light with wavelengths generally in the range of 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. The visible LED can be a green LED. A sensor detects the emitted light, and more specifically, the light transmitted or scattered by the fluid passing through a detection window. The detected intensity of the transmitted or scattered light can indicate the fluid's transmittance, opacity, and / or other physical properties. Four measurements—two for transmitted light and two for scattered light—are provided to a processor to execute an algorithm to determine the blood concentration of the fluid passing through the detection window.

[0010] The manifold includes a housing defining a manifold volume. The manifold may include a head coupled to a body, the body cooperating with the head to define the manifold volume. The head may include an inlet fitting configured to removably receive at least one suction tube. The body may define an outlet opening in fluid communication with the manifold volume and the inlet fitting. A seal may be coupled to the housing and sized to cover the outlet opening. A filter element may be disposed within the manifold volume. The outlet opening may be offset relative to the longitudinal axis of the manifold and configured to function as a valve actuator for a rotary valve of a medical waste collection system. The manifold may include a body portion, a first leg, and / or a second leg extending proximally from the body portion. The first and second legs may be spaced apart from each other by a gap. The manifold may include arms, locking elements, ridges, and / or fasteners. An edge may be provided on the first leg and define the outlet opening. Each of these arms includes a proximal guide surface positioned distal to the edge. The distal guide surface of the fastener may be positioned proximal to the edge and proximal to the proximal guide surface of the arm. The proximal guide surface of the ridge can be positioned distal to the edge, distal to the distal guide surface of the fastener, and distal to the proximal guide surface of the arm. The distal guide surface of the locking element can be positioned distal to the edge, distal to the distal guide surface of the fastener, distal to the proximal guide surface of the arm, and distal to the proximal guide surface of the ridge. All internal features of the manifold can include a body with an offset outlet opening or a body with a first leg and a second leg.

[0011] At least a portion of the manifold housing is optically transparent to define a detection window. This detection window is configured to be positioned near or between the transmitter and sensor of the sensor assembly. The transmitter and sensor of the sensor assembly are configured to detect the optical properties of the fluid passing through the detection window. This portion of the housing defining the detection window may be formed of a transparent material. The manifold may include a protrusion. This protrusion may be disposed on the manifold and extend longitudinally in a proximal-to-distal direction. The protrusion may include a coupling feature configured to engage the module housing of the fluid characterization module. The coupling feature may be a guide rail sized to be slidably positioned, having a notch defined by the module housing. The protrusion may define a reservoir configured to facilitate the separation of gas from liquid in the fluid before the fluid characterization module measures transmitted and scattered light. The reservoir may be positioned below the manifold volume. The accumulation of fluid within the reservoir provides a brief period during which gas can separate from liquid.

[0012] The manifold may also include flow guides disposed within the housing. The flow guides include various geometries configured to provide a tortuous path for fluid within the manifold. The flow guides are disposed within the manifold volume and may be at least partially disposed within the head. These geometries may cooperate with the internal geometry of the housing to define fluid flow paths, liquid flow paths, and gas flow paths. The gas flow path may be located near the upper aspect of the manifold, and the liquid flow path may be located near the lower aspect of the manifold. The liquid flow path may be at least partially defined by a reservoir including a detection window. The flow guides may include a first baffle and a second baffle, defining a gas inlet, a gas passage, a liquid passage, and a fluid outlet. The second baffle and the manifold housing may cooperate to define a liquid inlet between the manifold volume and the reservoir. The first baffle is configured to provide a tortuous path for fluid entering the manifold through the inlet fitting. Separated gas is drawn through the gas passage and the fluid outlet to pass through a filter element and an outlet opening. Separated liquid may simultaneously be drawn through the liquid inlet by vacuum provided by a medical waste collection system. The separated liquid can be further aspirated through a reservoir including a detection window, a liquid channel, and a fluid outlet. The liquid flow path and the gas flow path can be connected before the fluid outlet.

[0013] A flow guide may be positioned proximal to the filter element. The flow guide may define a detection window. A fluid characterization module may be disposed within the manifold. The flow guide may include at least one redirecting orifice in fluid communication with a transverse channel extending longitudinally within the manifold. The flow guide may define a central channel communicating with a reservoir and a gas inlet located near the proximal end of the manifold. The filter element may be non-cylindrical and stacked with the flow guide. The filter element may be semi-cylindrical, having a flat surface positioned on top of the upper surface of the flow guide.

[0014] The manifold may include a second filter element. The second filter element may be disposed within a reservoir. A pipette may be at least partially placed within the reservoir. A vacuum provided by the system is drawn through the pipette to draw liquid from the reservoir against gravity through a first end of the pipette. The liquid is drawn through the pipette and further through a detection window defined by a second protrusion. The pipette may extend through the second filter element.

[0015] The head may define an auxiliary sleeve extending from an auxiliary opening. A first inlet fitting may extend upward from an upper baffle of the auxiliary sleeve. The auxiliary sleeve is in fluid communication with the manifold volume. The fluid characterization module is configured to be removably positioned through the auxiliary opening and supported within the auxiliary sleeve. A tray facilitates the removable positioning of the fluid characterization module within the auxiliary sleeve, enabling it to optically communicate with the suction path and, particularly, with the inflow of fluid via the first inlet fitting. The fluid characterization module may include a printed circuit board (PCB) assembly whose dimensions and shape are determined to match the opening of the tray's cavity. The fluid characterization module includes a sensor assembly. The fluid characterization module may also include one or more of the following: an LED driver integrated circuit, a photosensor integrated circuit, a microcontroller communicating with the LED driver integrated circuit and the photosensor integrated circuit, a communication module, a battery, and a battery management integrated circuit.

[0016] Radio frequency identification (RFID) tags can be attached to manifolds and positioned for detection by data readers of the medical waste collection system. The RFID tag transmits data from its memory to the data reader, and the controller of the medical waste collection system performs subsequent actions. The RFID tag's memory can store calibration data for the transmitter and / or sensors.

[0017] The fluid characterization module can be integrated with the receiver. The fluid characterization module can be mounted on the inlet mechanism of the receiver. This inlet mechanism includes a suction fitting configured to penetrate a seal for at least partial positioning within the manifold. A transmitter and sensor can be coupled to the inlet mechanism and positioned relative to the detection window on a first leg of the body. Implementations of the fluid characterization modules can be used individually or in combination. The manifold and receiver can house individual fluid characterization modules. The outputs of each fluid characterization module can be compared and / or combined with each other via a controller or processor to assess or improve the accuracy of a determined blood concentration within the fluid. The output from one fluid characterization module can be used to facilitate the calibration of another fluid characterization module.

[0018] The fluid characterization module provides the ability to adjust the gain of one or both sensors. The sensor gain is increased when the light detected by the sensor is below a predetermined transmittance threshold. The sensor gain is decreased when the light detected by the sensor exceeds the predetermined transmittance threshold. The sensor assembly may include additional sensors that selectively operate based on the detected light transmittance. The brightness of the emitter can be adjusted based on the detected light transmittance.

[0019] The blood management system may include a medical waste collection system, a sponge system, and a user interface. Data may be transmitted to the patient's electronic medical record (EMR). The medical waste collection system may perform QBL analysis and wirelessly transmit blood volume data to the user interface. Alternatively, another device, such as a mobile device or a remote server, may receive the data described herein and execute algorithms to perform QBL analysis. The sponge system is configured to determine the amount of blood loss contained within absorbent materials (e.g., surgical sponges). The user interface acts as a hub for providing acute patient information to attending medical personnel. Blood loss may be displayed in real time on the control panel and / or user interface throughout the procedure. Blood loss may also be displayed as a graphical representation of time elapsed since the start of the procedure. The user interface may trigger alarms, warnings, and all other critical information. Alarms or warnings may be based on thresholds or guidelines wirelessly pushed to the user interface. Attached Figure Description

[0020] The advantages of this disclosure will be readily apparent, as they can be better understood when considered in conjunction with the accompanying drawings and by referring to the following detailed description.

[0021] Figure 1 This is a perspective view of a medical waste collection system, in which a manifold is removably inserted into the receiver of the medical waste collection system.

[0022] Figure 2 yes Figure 1 A cross-sectional view of a medical waste collection system is provided, along with schematic diagrams of some optional components of the medical waste collection system.

[0023] Figure 3 It is a perspective view of the manifold, and a representation of the fluid characterization module including sensor components.

[0024] Figure 4 yes Figure 3 An exploded view of a manifold, wherein the manifold includes a head, a flow guide, a filter element, and a body.

[0025] Figure 5 yes Figure 3 The perspective view of the manifold obtained along section line 5-5.

[0026] Figure 6 yes Figure 3 The front view of the manifold obtained along section line 6-6.

[0027] Figure 7 This is a cross-sectional front view of another manifold, in which the first baffle of the guide is positioned near the inlet fitting at the head.

[0028] Figure 8This is an exploded view of another manifold, in which the flow guide is positioned close to the filter element. This fluid characterization module can be installed within the manifold.

[0029] Figure 9 yes Figure 8 The front view of the manifold obtained along section line 9-9.

[0030] Figure 10 This is an exploded view of another manifold, in which the flow of fluid is filtered by a filter element before encountering the guide.

[0031] Figure 11 yes Figure 10 The front view of the manifold obtained along section line 11-11.

[0032] Figure 12 This is a perspective view of another manifold, in which a protrusion defining the reservoir extends downward from the head of the manifold.

[0033] Figure 13 yes Figure 12 An exploded view of a variant of the manifold, in which a second filter element and a suction tube are disposed within the reservoir.

[0034] Figure 14 yes Figure 13 The front view of the manifold obtained along section line 14-14.

[0035] Figure 15 yes Figure 12 A cross-sectional front view of another variation of the manifold, in which the straw extends through the second filter element.

[0036] Figure 16 This is a perspective view of another manifold, in which the fluid characterization module can be inserted through an accessory port of the manifold.

[0037] Figure 17 yes Figure 16 A perspective view of the fluid characterization module.

[0038] Figure 18 This is a perspective view of the receiver of the medical waste collection system, and another manifold is configured to be removably inserted into the receiver. The fluid characterization module can be coupled to the manifold.

[0039] Figure 19 This is a perspective view of the receiver of the medical waste collection system, and another manifold is removably inserted into the receiver.

[0040] Figure 20 yes Figure 19 The receiver and manifold are obtained along section line 20-20.

[0041] Figure 21 yes Figure 19 A rear-view perspective view of a portion of the manifold, wherein the first leg of the manifold defines a detection window configured to be positioned near the sensor assembly of the receiver.

[0042] Figure 22 This is a perspective view of the receiver's inlet mechanism. The sensor assembly is connected to the inlet mechanism.

[0043] Figure 23 This is a schematic diagram of the fluid characterization module and the electronic components of an optional medical waste collection system for quantifying blood loss.

[0044] Figure 24 It is a perspective view of another manifold, wherein the distal guide and the proximal guide can be actuated between the first and second storage sections based on the liquid levels in the first and second storage sections.

[0045] Figure 25 yes Figure 24 Top view of the manifold.

[0046] Figure 26 This is an implementation scheme for the sensor assembly.

[0047] Figure 27 It is a graphical representation of the molar extinction coefficient for a series of wavelengths of light for each of hemoglobin (Hb) and oxyhemoglobin (HbO2).

[0048] Figure 28 It is an electrical schematic diagram that includes a microcontroller for adjusting the gain of sensor components.

[0049] Figure 29 It is the light transmittance (U) that changes over time. IN ) and gain (U OUT The graphical representation of this is shown, where the gain is adjusted based on the light transmittance associated with a predetermined threshold.

[0050] Figure 30 It is the light transmittance (U) that changes over time. IN ) and gain (U OUT Another graphical representation of this shows that the gain is adjusted based on light transmittance related to a predetermined threshold. This gain adjustment illustrates the hysteresis effect.

[0051] Figure 31 It represents a blood management system that includes a medical waste collection system, a sponge system, and a user interface. Detailed Implementation

[0052] Figure 1 and Figure 2A medical waste collection system 40 is shown for collecting waste generated during medical procedures, particularly surgical procedures. This waste may include fumes, body tissues, and waste fluids, such as bodily fluids and irrigation solutions. Typically, medical procedures require large quantities of saline and / or other irrigation solutions to flush anatomical sites. The medical waste collection system 40 collects and / or stores the waste until it is needed or desired to be emptied and disposed of. The medical waste collection system 40 may be delivered to and operatively coupled to a docking station through which the waste is emptied. The docking station may include an unloading pump and a docking controller operatively coupled to the unloading pump. The docking station may also take any applicable form, such as that disclosed in common U.S. Patent No. 7,621,898, published November 24, 2009, the entire contents of which are incorporated herein by reference.

[0053] The medical waste collection system 40 may include a base 42 and wheels 44 for moving the system 40 along a floor surface within a medical facility. The medical waste collection system 40 includes at least one waste container 46 defining a waste volume for collecting and storing waste. A vacuum source 48 may be supported on the base 42 and configured to apply suction to the waste container 46 via one or more internal lines 50. The vacuum source 48 may include a vacuum pump 52 and a vacuum regulator 54 (in... Figure 2 (Illustrated schematically), it is supported on a base 42 and in fluid communication with a waste container 46. A vacuum regulator 54 is configured to regulate the magnitude of the suction force applied to the waste container 46 by the vacuum pump 52. Applicable structures and operations of several subsystems of the medical waste collection system 40 are disclosed in U.S. Patent Publication No. 2005 / 0171495, published August 4, 2005; International Publication No. WO 2007 / 070570, published June 21, 2007; International Publication No. WO 2014 / 066337, published May 1, 2014; and International Publication No. 2017 / 15284, published June 29, 2017, the entire contents of which are incorporated herein by reference. In other configurations, the vacuum source 48 may be a separate unit that can be removably coupled to the medical waste collection system 40 to apply suction force to the waste container 46. The appropriate structure and operation of this arrangement are disclosed in common U.S. Patent No. 10,105,470, published on October 23, 2018, the entire contents of which are incorporated herein by reference.

[0054] The front of the base 42 may define a window 56 to allow a user to view the waste container 46. In embodiments where the waste container 46 comprises a transparent or translucent material, the user can see the height of the waste in the waste container 46 through the window 56. The medical waste collection system 40 may also include a light source (not shown) configured to illuminate the waste container 46 to assist the user in observing the height of the waste in the waste container 46. Particularly when the waste includes bodily fluids such as blood and non-blood fluids, visualizing the contents of the waste container 46 may be particularly advantageous for qualitative assessment of the degree of blood loss. Qualitative assessment can complement the quantitative blood loss (QBL) analysis described herein. For example, the user can visually monitor the color of the waste through the window 56, and if the color becomes too red, indicating excessive blood loss, the user can choose to view a control panel 58 displaying this quantitative blood loss analysis.

[0055] The control panel 58 and the controller 60, including the processor, are mounted on the base 42. Figure 2 (The diagram is shown schematically.) Communication. Controller 60 is configured to generate a signal to vacuum regulator 52 to operate vacuum regulator 52, thereby adjusting the vacuum level in waste container 46. In another configuration, controller 60 is configured to generate a signal to operate vacuum source 38 to maintain or adjust the vacuum level in waste container 46.

[0056] The medical waste collection system 40 includes at least one receiver 62 supported on a base 42. In the most general sense, the receiver 62 defines an opening 64 (see [reference needed]). Figure 18 The opening is sized to removably receive at least a portion of the manifold 66 to be described. Figure 2 A single receiver is shown, but two receivers associated with a corresponding one of multiple waste containers are considered. A suction path from the suction tube to the waste container 46 can be established via a manifold 66 removably inserted into the receiver 62. That is, a vacuum generated by the vacuum source 38 is drawn onto the suction tube, and waste from the surgical site is drawn through the manifold 66 and then through the receiver 62 into the waste container 46. The manifold 66 includes features to be described that are configured to facilitate QBL analysis of the fluid inflow. The manifold 66 may be a disposable component.

[0057] The fluid characterization module 68 is configured to facilitate the quantification of blood concentration within the fluid being drawn through the medical waste collection system 40 under suction. Quantifying the blood concentration within the fluid facilitates QBL analysis. The fluid characterization module 68 includes a sensor assembly 70 and may also include a module housing 72. In some embodiments, the fluid characterization module 68 is integrated with or configured to be coupled to the manifold 66, and in other embodiments, the fluid characterization module 68 is integrated with the medical waste collection system 40. Figure 2 One embodiment is schematically illustrated, in which the sensor assembly 70 of the fluid characterization module 68 is integrated with the medical waste collection system 40 via an internal conduit 73 in fluid communication with or located near the receiver 62. Other suitable locations for the fluid characterization module 68 are considered, such as locations near or within the waste container 46 and / or receiver 62. The fluid characterization module 68 is configured to generate a signal for determining the blood concentration within the fluid. In embodiments where the fluid characterization module 68 is integrated with the medical waste collection system 40, the conduit 73 may be optically transparent, although these conduits may discolor or develop an odor over time. A cleaning line may be provided, and this cleaning line is configured to guide water and / or cleaning agents through the cleaning line and conduit 73 to maintain its optical properties. A suitable cleaning system is disclosed in the aforementioned U.S. Patent No. 7,612,898.

[0058] Now for reference Figure 3-6 An embodiment of manifold 66 is shown. Manifold 66 includes a housing 74 defining a manifold volume 76. Manifold 66 may include a head 78 coupled to a body 80, or, in an alternative configuration, the housing 74 of manifold 66 may have a single or integral structure. The head 78 and body 80 cooperate to define the manifold volume 76. The head 78 may include an inlet fitting 88 configured to removably receive at least one suction tube (not shown). Body 80 may define an outlet opening 82 in fluid communication with the manifold volume 76 and the inlet fitting 88. A seal 84 may be coupled to housing 74 and sized to cover the outlet opening 82. A filter element 86 may be disposed within the manifold volume 76. In the broadest sense, filter element 86 includes orifices, pores, or other structures configured to trap or collect semi-solid or solid waste entrained in the fluid being drawn through manifold 66 under suction. It should be recognized that not all configurations of the manifold require the use of a filter element, and the filter element may be located in a position separate from the manifold volume, which is in fluid communication with the outlet opening 82 of the manifold 66.

[0059] Some embodiments of manifold 66 include an outlet opening 82 offset relative to the longitudinal axis of manifold 66 and configured to act as a valve actuator for a rotary valve of medical waste collection system 40. More specifically, body 80 may be generally cylindrical for insertion into receiver 62 and then rotated to establish fluid communication between manifold volume 76 and waste container 46 in a manner disclosed in common U.S. Patent No. 7,615,037, published November 10, 2009, the entire contents of which are incorporated herein by reference. In an alternative embodiment of manifold 66, body 80 includes features to be described that are inserted into manifold 66 in a proximal direction and displace manifold from receiver 62 in a distal direction as disclosed in common International Publication No. WO2020 / 209898, published October 15, 2020, which is incorporated herein by reference in its entirety. It should be understood that the features of manifold 66 (particularly internal features relevant to facilitating QBL analysis) may be included in any embodiment of body 80. In other words, refer to... Figure 3-15 The described features may include Figure 16-21 The main body 80 shown, and referenced Figure 16-21 The described features may include Figure 3-15 The main body shown is 80.

[0060] Manifold 66 may include a protrusion 90. This protrusion 90 may function as a module connector, allowing the module housing 72 of the fluid characterization module 68 to be operatively coupled to the manifold 66. The protrusion 90 may be disposed on a head 78 and extend longitudinally in a proximal-to-distal direction. The protrusion 90 may be elongated and have a width less than its length. The protrusion 90 may include a coupling feature configured to engage the module housing 72 of the fluid characterization module 68. For example, the coupling feature may be a guide rail sized to be slidably positioned, wherein a notch 92 is defined by the module housing 72. Alternatively, the fluid characterization module 68 may be clamped or otherwise secured to the protrusion 90. It should be understood that any suitable configuration of the housing 74 or other components of the manifold 66 may be configured to be removably coupled to the fluid characterization module 68.

[0061] At least a portion of the housing 74 of the manifold 66 is optically transparent to define a detection window 94. The detection window 94 is configured to be located near or between at least one transmitter 96 and at least one sensor 98 of the sensor assembly 70. In a manner further described, the transmitter 96 and sensor 98 of the sensor assembly 70 are configured to detect the optical properties of fluid passing through the suction path. In some embodiments, this portion of the housing 74 defining the detection window 94 may be formed of a transparent material (e.g., transparent plastic). The entire housing 74 may be formed of transparent plastic, wherein this portion of the housing 74 is to be positioned between the transmitter 96 and the sensor 98 to form the detection window 94. In some embodiments, the housing 74 may be formed of a translucent or opaque material having cutouts sized to be fixedly connected to an optically transparent panel. Figure 5 and Figure 6 The embodiment shows a protrusion 90 defining a detection window 94. In this arrangement, at least a portion of the protrusion 90 may be optically transparent, such that when the protrusion 90 is positioned relative to the protrusion 90 in the slot 92 of the fluid characterization module 68, the sensor assembly 70 is positioned relative to the protrusion 90 to optically communicate with the detection window 94.

[0062] For illustrative purposes only, Figure 3 The fluid characterization module 68 is shown as free-floating. In one embodiment, the module housing 72 is coupled to an adapter (not shown). This adapter may include data and power connections and is configured to be removably coupled to a complementary socket on the medical waste collection system 40. Establishing the data and power connections, the module housing 72 defining the slot 92 may be slidably coupled, for example, from the front of the manifold 66 along the protrusion 90. In another embodiment, the fluid characterization module 68 is integrated with the receiver 62 such that the module housing 72 is not necessarily visible to the user. The manifold 66 is inserted into the receiver 62 such that the slot 92 is slidably coupled along the protrusion 90. It is understood that when the manifold 66 is inserted into the receiver 62 in a proximal direction, some modifications to the housing 74 of the manifold 66 may be necessary to facilitate removable coupling of the manifold 66 and the fluid characterization module 68.

[0063] As described, sensor assembly 70 includes emitter 96 and sensor 98. Emitters 96 and 97 are configured to emit energy, and sensors 98 and 99 are configured to detect the emitted energy. An exemplary embodiment is an optical sensor assembly utilizing light energy, wherein emitters 96 and 97 are light-emitting diodes (LEDs), and sensors 98 and 99 are photodetectors. Emitters 96 and 97 and sensors 98 and 99 are configured to be positioned relative to detection window 94. Exemplary embodiments include two emitters and two sensors, and two emitters and four sensors, but it is understood that more or fewer of any of these can be provided. One of the emitters (also referred to herein as first emitter 96) may be positioned relative to two sensors relative to detection window 94, and another of the emitters (referred herein as second emitter 97) may be positioned relative to two other sensors relative to detection window 94. The four sensors detect the emitted light, and more specifically detect the light after it has been fluidly transmitted or scattered through detection window 94. The intensity of transmitted or scattered light can indicate the transmittance, opacity, and / or other physical properties of a fluid. In an exemplary arrangement, a first sensor 98 detects transmitted light from a first emitter 96, a second sensor 99 detects transmitted light from a second emitter 97, a third sensor (not shown) detects scattered light from the first emitter 96, and a fourth sensor (not shown) detects scattered light from the second emitter 97. These four measurements—two of the transmitted light and two of the scattered light—are provided to a processor to execute an algorithm to determine the blood concentration of the fluid passing through detection window 94.

[0064] An alternative arrangement includes two sensors—a first sensor 98 and a second sensor 99—where a first emitter 96 is positioned opposite a detection window 94 of one of the sensors 98, and a second emitter 97 is positioned opposite a detection window 94 of the other of the sensors 99. The first sensor 98 detects transmitted light from the first emitter 96 and scattered light from the second emitter 97. The second sensor 99 detects transmitted light from the second emitter 97 and scattered light from the first emitter 96. Positioning the emitters 96 and 97 on opposite sides of the detection window 94 limits or prevents crosstalk between the wavelengths of the light emitted by the emitters 96 and 97. In another embodiment, the first emitter 96 and the second emitter 97 can be pulsed; that is, each emitter is sequentially irradiated at a high frequency. Alternating pulses of the first emitter 96 and the second emitter 97 can also limit or prevent crosstalk and further reduce the thermal effects of the LED.

[0065] Implementation schemes that include two sensors are particularly suitable for applications with... Figure 26The schematic representation of this arrangement is shown in the diagram for a space-constrained application. The module housing 72 of the fluid characterization module 68 defines a channel for guiding fluid or liquid through it, which is identified as a detection window 94. Figure 26 The arrows schematically represent the light being emitted and detected. Visible light LEDs and infrared LEDs (e.g., first emitter 96 and second emitter 97) are configured to emit visible light (G... IN ) and infrared light (R IN The fluid being drawn in through the suction path (SP) is guided into the module housing 72. Visible light LEDs and infrared LEDs can be disposed within the openings of the module housing 72. As previously mentioned, some visible light can be transmitted through the fluid (G... T ) transmission, while some visible light can be scattered by the fluid (G) S Similarly, some infrared light can pass through fluids (R). T ) transmission, while some infrared light can be scattered by the fluid (R S A photodetector (e.g., a first sensor 98 and a second sensor 99) is configured to detect transmitted visible light (G). T ), transmitted infrared light (R) T ), scattered visible light (G) S ) and scattered infrared light (R S These values ​​provide the algorithm with four parameters to determine the blood concentration within the fluid. A photodetector may be positioned within an opening in the module housing 72. Two or four photodetectors may be present. Figure 26 The fluid characterization module 68 is a non-restrictive design, and in particular, the size and shape of the module housing 72 can be adjusted to accommodate space-constrained and / or removably coupled structures. Similarly, the arrangement of the transmitters 96, 97 and sensors 98, 99 can be configured in any suitable manner to obtain the necessary measurements of transmitted and scattered light.

[0066] The first emitter 96 can be an infrared LED, and the second emitter 97 can be a visible light LED. The infrared LED can be configured to emit light with wavelengths generally in the range of 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 can be configured to emit light with wavelengths generally in the range of 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. The visible light LED can be a green LED. Figure 27This is a graphical representation of the molar extinction coefficients of each of hemoglobin (Hb) and oxyhemoglobin (HbO2) across a range of wavelengths. Hemoglobin is an important protein in red blood cells, while oxyhemoglobin is the oxygen-carrying form of hemoglobin, which is bright red in color. The red color of blood, determined by oxyhemoglobin, is influenced by the transmittance and scattering of light directed through the blood. Light transmittance can be a fluid characteristic detected by the fluid characterization module 68. It has been determined that green and infrared light are likely optimal for determining the blood concentration within a liquid. Measurements of infrared light absorbed by the fluid are determined by the reduction in transmitted light due to the presence of blood in the fluid. In one embodiment, the absorption rate of infrared light relative to scattered light from visible light is calculated and used to quantify the blood concentration in the fluid.

[0067] It has been observed that waste pumped through manifold 66 may include a mixture of gas and liquid (e.g., air and blood, respectively). The gas-liquid mixture may result from the gas and liquid being pumped into the suction tube coupled to inlet fitting 88 and / or from bubbles generated by collisions and turbulence within the geometry of manifold 66. The presence of gas within the liquid may affect its optical properties and may therefore undesirably impair the accuracy of measurements of transmitted and / or scattered light. (Continue to refer to...) Figure 4-6 The protrusion 90 defines the reservoir 100, which is configured to facilitate the separation of gas from liquid in the fluid before the fluid characterization module 68 measures transmitted and scattered light. Figure 5 and Figure 6 As best shown, reservoir 100 can be positioned below manifold volume 76. Conventionally, liquid inlet 102 can define the boundary between manifold volume 76 and reservoir 100, but reservoir 100 can also be considered a sub-volume of manifold volume 76. Due to the relative size of liquid inlet 102, flow accumulates within reservoir 100, and further within manifold volume 76. The accumulation of fluid within reservoir 100 provides a brief period during which gas can separate from liquid, for example, bubbles separating from blood and other liquids according to bubble dynamics.

[0068] Manifold 66 may have a flow guide 104 disposed within housing 74. The flow guide 104 includes various geometries configured to provide a tortuous path to the fluid within manifold 66. Among other advantages, the tortuous path restricts turbulence within manifold 66, facilitates air-liquid separation within the fluid, and provides fluid filtration upstream of sensor assembly 70. (Continuing to the previous paragraph) Figure 4-6The guide element 104 is disposed within the manifold volume 76 and may be at least partially disposed within the head 78. The geometry described may mate with the internal geometry of the housing 74 to define fluid flow paths (FFP) (i.e., including liquid and gas), liquid flow paths (LFP), and gas flow paths (GFP). When the gas density is less than the liquid density, the gas flow path may be positioned near the upper portion of the manifold 66, while the liquid flow path may be positioned near the lower portion of the manifold 66. In the illustrated embodiment, the liquid flow path is at least partially defined by the reservoir 100 including the detection window 94.

[0069] The flow guide 104 may include a first baffle 106 and a second baffle 108, defining a gas inlet 110, a gas passage 112, a liquid passage 114, and a fluid outlet 116. Furthermore, the second baffle 108 and the housing 74 of the manifold 66 may cooperate to define a liquid inlet 102 between the manifold volume 76 and the reservoir 100. The first baffle 106 is configured to provide a tortuous path for fluid entering the manifold 66 through the inlet fitting 88 (and more specifically through the proximal end 118 of the inlet fitting 88). This tortuous path, along with the size of the liquid inlet 102, may cause at least some accumulation of fluid within the manifold volume 76. As described, this accumulation provides a brief period during which gas can separate from the liquid. The separated gas occupies the portion of the manifold volume 76 above the liquid and is drawn through the gas inlet 110 by a vacuum provided by the medical waste collection system 40. The separated gas is further drawn through gas channel 112 and through fluid outlet 116 to pass through filter element 86 and outlet opening 82. The separated liquid can be simultaneously drawn through liquid inlet 102 by vacuum provided by medical waste collection system 40. The separated liquid can be further drawn through reservoir 100, liquid channel 114, and fluid outlet 116, including detection window 94. The liquid passing through detection window 94, to be measured by fluid characterization module 68, contains a small amount of gas, almost no gas, or no gas, and thus the accuracy of the measurements from fluid characterization module 68 can be advantageously maintained. For example, the relative absence of bubbles eliminates optical interference caused by the refractive index of bubble surfaces.

[0070] like Figure 5 and Figure 6Ideally, the liquid flow path and the gas flow path can be connected before the fluid outlet 116. Specifically, the liquid channel 114 and the gas channel 112 merge before the fluid outlet 116. Since the liquid has already been measured by the fluid characterization module 68 located upstream of the connection between the liquid and gas flow paths, it may not be necessary to maintain their separation while the fluid is drawn through the rest of the manifold 66. Thus, the detection window 94 can be positioned between the liquid inlet 102 and the liquid channel 114, and fluidly separated from the gas channel 112 (based on the direction of suction through the manifold 66).

[0071] To facilitate fluid buildup and tortuous path within the manifold volume 76, a first baffle 106 is positioned near the proximal end 118 of the inlet fitting 88 within the head 78. More specifically, the first baffle 106 may extend distally from the rear baffle 120 to a distal edge 122, which is positioned distal to the proximal end 118 of the inlet fitting 88. In other words, the first baffle 106 and the inlet fitting 88 may... Figure 6 The front view shows an "overlapping" arrangement. Furthermore, the liquid inlet 102 can be positioned distal to the proximal end 118 of the inlet fitting 88, and the first baffle 106 can be further positioned near the gas inlet 110. In this arrangement, the first baffle 106 blocks a direct path from the proximal end 118 of the inlet fitting 88 to the gas inlet 110, effectively requiring the fluid flow path itself to be flipped at least once to allow either the gas inlet 110 or the liquid inlet 102 to approach the fluid inflow. The inlet fitting 88 can be laterally offset toward the wall of the housing 74 to achieve an overlapping positioning relative to the first baffle 106. The first baffle 106 (and / or the housing 74) can be contoured to promote less turbulence, which can further facilitate gas-liquid separation. The fluid flow path can accumulate in the manifold volume 76, wherein multiple portions of the accumulated liquid are drawn from below through the liquid inlet 102 as described above, and multiple portions of the gas separated from the liquid are drawn from above through the liquid inlet 102 as described above. Considering the expected inflow rate into manifold volume 76, the size of liquid inlet 102 ensures the expected accumulation, for example, to provide sufficient opportunity for gas to separate from the liquid.

[0072] When the fluid is primarily a gas with a small amount of liquid, as previously described, the manifold volume 76 is effectively emptied through the reservoir 100. When the fluid is primarily liquid, the accumulation of liquid within the manifold volume 76 can reach the gas inlet 110. The gas inlet 110 acts as an overflow opening, after which both gas and liquid can be drawn through the gas passage 112 and fluid outlet 116 of the guide 104. The continuous flow of liquid drawn through the liquid flow path and measured within the detection window 94 prevents any blockage or loss of suction.

[0073] The associated geometry of the gas inlet 110, manifold volume 76, and liquid channel 114 can be designed to minimize potential blockages and maximize inflow through inlet fitting 88. For example, the outflow rate of liquid through the liquid flow path can be based on the dimensions of the liquid channel 114, and perhaps more importantly, on the dimensions of the reservoir 100 defined by the protrusion 90. As described, the detection window 94 can be part of the optically transparent protrusion 90, and in some embodiments, the entire head 78 can be optically transparent. Due to the relatively high light absorptivity of blood, especially at higher concentrations, it is advantageous that the emitters 96, 97 and sensors 98, 99—positioned relative to the protrusion 90—are sufficiently close to improve measurement accuracy. Therefore, in some embodiments, the width of the protrusion 90, and thus the width of the detection window 94, is no greater than three-quarters of an inch, and more specifically, about half an inch. The width of the protrusion 90 can affect the flow rate of liquid through the detection window 94, and thus the outflow rate of liquid through the liquid flow path. Furthermore, limiting the width of the protrusion 90 can correspondingly limit the required operating range of the transmitters 96, 97 and sensors 98, 99, thereby improving accuracy with lower-cost electronic components. In addition to quantifying blood loss, the implementation with the flow guide 104, which can also be used with other applications of continuous flow measurement (such as intravenous pumps and arthroscopy), can benefit from the removal of gas from the liquid.

[0074] Figure 7An alternative embodiment of the guide 104 is shown, in which a separate liquid channel defined by the guide 104 may not exist. Instead, a first baffle 106 is positioned proximal to the proximal end 118 of the inlet fitting 88 to encounter the incoming fluid and guide it to the manifold volume 76 and reservoir 100 in a less turbulent manner. Depositing the incoming fluid into the reservoir 100 can agitate the accumulated fluid, thereby promoting the homogeneity of the fluid collected in the reservoir 100, where the fluid characterization module 68 is measuring the fluid collected in the reservoir 100. The inlet 110 initially provides a gas passage; however, once sufficient fluid has accumulated in the reservoir 100 and manifold volume 76, the inlet 110 can function as an overflow opening, after which both gas and liquid can be drawn through the fluid outlet 116 of the guide 104.

[0075] Now for reference Figure 8 and Figure 9 Another embodiment of the manifold 66 is shown, in which the guide element 104 is positioned near the filter element 86. In other words, the guide element 104 is positioned closer to the outlet opening 82 than the filter element 86. In this arrangement, the fluid entering the manifold volume 76 is filtered by the filter element 86 before encountering the detection window 94. Thus, any tissue or semi-solid material that might affect the optical properties of the fluid is removed. In other respects, the guide element 104 may be functionally similar to the previously described embodiment with similar reference numerals identifying similar components. Specifically, Figure 9 A flow guide 104 is shown, which includes a liquid inlet 102, a gas inlet 110, and a fluid outlet 116. The flow guide 104 defines a gas passage 112 between the gas inlet 110 and the fluid outlet 116, and further defines a liquid passage 114 between the liquid inlet 102 and the fluid outlet 116.

[0076] In this embodiment, the flow guide 104 defines a detection window 94. More specifically, the liquid channel 114 may define the detection window 94, and therefore at least a portion of the flow guide 104 is optically transparent. In this embodiment, the fluid characterization module 68 is disposed within the manifold 66. Figure 9The illustration primarily shows a fluid characterization module 68 positioned within a body 80, with a liquid channel 114 disposed near or between the sensor assembly 70 of the fluid characterization module 68 and the sensor assembly 70. This embodiment may require a fluid characterization module 68 including a communication module (not identified) that wirelessly transmits signals to a medical waste collection system 40, enabling a controller or processor 60 to utilize these signals in real time to determine blood concentration and thereby perform QBL analysis. Alternatively, modifications to the body 80 are considered, such that the fluid characterization module 68 is positioned outside the manifold 66 and optically communicates with a flow guide 104 via the body 80, a portion of which may also be optically transparent. With the fluid characterization module 68 engaged with the liquid channel 114 of the flow guide 104, it is understood that this embodiment achieves sufficient separation of gas and liquid in the fluid before measuring the optical properties of the fluid, without including protrusions defining a reservoir.

[0077] Figure 10 and Figure 11 Another embodiment of the manifold 66 is shown, in which fluid is filtered by a filter element 86 before encountering a detection window 94. While the previous embodiment included a fluid characterization module 68 disposed within the body 80 of the manifold 66 to illustrate the distal positioning of the filter element 86 relative to the detection window 94, the flow guide 104 of this embodiment redirects the fluid distally toward the reservoir 100. Thus, the fluid characterization module 68 can be coupled to the exterior of the head 78 of the manifold 66 (and possibly to the exterior of the receiver 62), regardless of the initial inflow of fluid through the filter element 86. The flow guide 104 includes at least one redirecting orifice 124 in fluid communication with a transverse channel 126 extending longitudinally within the manifold 66. The flow guide 104 further defines a reservoir 100 communicating with the transverse channel 126 and further with an outlet opening 82. Furthermore, the flow guide 104 may define a central channel 128 communicating with the reservoir 100 and a gas inlet 110 located near the proximal end of the manifold 66. A ridge may separate the reservoir 100 from the transverse channel 126, wherein the dimensions of the ridge are determined to receive the fluid characterization module 68. The reservoir 100 is positioned between the sensor assemblies 70. To accommodate the transverse channel 126, the filter element 86 may be non-cylindrical and positioned in a stacked arrangement with the flow guide 104. For example, the filter element 86 may be semi-cylindrical, having a plane configured to be supported on the top of the upper surface of the flow guide 104.

[0078] refer to Figure 9 and Figure 10As indicated by the arrows, fluid enters manifold 66 through inlet fitting 88 and is then filtered by filter element 86. Some fluid enters reservoir 100 through holes in the base of filter element 86, and some enters manifold volume 76 through the proximal end of filter element 86. Liquid within the fluid can be drawn toward reservoir 100 through central channel 128, while gas separation allows it to be drawn toward outlet opening 82 through gas inlet 110. Some fluid is drawn through redirection orifice 124 to be directed distally along lateral channel 126. Near the distal end of manifold 66, the fluid is again redirected from distal to proximal direction to enter reservoir 100. The optical properties of the fluid passing through reservoir 100 are measured by sensor assembly 70 of fluid characterization module 68, and then it is drawn toward outlet opening 82 under suction.

[0079] In some implementations, a second filter element 130 may be provided. Now refer to Figure 12-16 The protrusion 90 of the manifold 66 can be shaped and sized to accommodate the second filter element 130. The illustrated embodiment shows the protrusion 90, which is cylindrical and extends downward from the head 78 of the manifold 66. Due to the size and shape of the protrusion 90, the reservoir 100 of this embodiment is configured to hold more fluid, for example, to allow for sufficient separation of gas and liquid within the fluid. The fluid characterization module 68 is positioned near the reservoir 100, and therefore the size of the protrusion 90 may not be constrained by the technical limitations of the sensor assembly 70.

[0080] The second filter element 130 is disposed within the storage tank 100. Figure 13 and Figure 14 In the first variant shown, the second filter element 130 includes a spacer 132 configured to abut the base 134 of the protrusion 90 and provide a gap between the second filter element 130 and the base 134. A straw 136 is at least partially disposed within the reservoir 100. The straw 136 includes a first end 138 disposed within the reservoir 100 and a second end 140 disposed within the manifold volume 76 (the boundary between the reservoir 100 and the manifold volume 76 is defined by a dashed line). The flow guide 104 includes a first baffle 106 defining a gas inlet 110. The first baffle 106 is required to guide the fluid inflow through the inlet fitting 88 into the reservoir 100 under the influence of gravity. Within the reservoir 100, the gas and liquid within the fluid can be separated as described above. Gas in the manifold volume 76 is drawn toward the outlet opening 82 through the gas inlet 110. Liquid accumulates within the reservoir 100.

[0081] The vacuum balance provided by system 40 is achieved through the suction tube 136. In other words, the vacuum at the second end 140 of the suction tube 136, against the force of gravity, draws liquid from the reservoir 100 through the first end 138 of the suction tube 136. The liquid is drawn through the suction tube 136 and further through the detection window 94 defined by the second protrusion 91. Conventionally, by being elongated and configured to be positioned within the slot 92 of the module housing 72, the second protrusion 91 may resemble certain embodiments of the aforementioned (first) protrusion 90. Figure 13 As shown, the second protrusion 91 defines a channel 142 that is in fluid communication with the reservoir 100 via the suction tube 136. The optical properties of the liquid through the detection window 94 are measured by the fluid characterization module 68.

[0082] In another variation, the straw 136 may extend through the second filter element 130. (See reference...) Figure 15 The protrusion 90 may be tapered and / or define a step 144, and the second filter element 130 is supported on the step 144 to provide a gap above the base 134 of the protrusion 90. The base of the second filter element 130 defines an opening, and the straw 136 includes the step 146 supported within the opening. Improved performance can be achieved by the straw 136 when the tapered portion is centered within the reservoir 100 relative to the base 134 of the protrusion 90 and the first end 138 of the straw 136. Liquid is drawn through the straw 136 and the detection window 94 of the second protrusion 91.

[0083] Now for reference Figure 16 and Figure 17 Another embodiment of the manifold 66 is shown, wherein the fluid characterization module 68 can be removably inserted into a portion of the housing 74 of the manifold 66. First, the features of the body 80, configured to engage complementary features with the receiver 62 of the medical waste collection system 40, are described. The manifold 66 includes an arm 148, a locking element 150, a spine 152, and / or a fastener 154. Conventionally, directional references (e.g., proximal, distal, upper, lower, above, below, etc.) are referenced to the... Figure 16 The manifold 66 in the illustrated orientation is configured such that it is inserted into the receiver 62. The housing 74 may include a body portion 156, a first leg 158, and / or a second leg 160. The first leg 158 and / or the second leg 160 may extend from the body portion 156, and more specifically, one or both of the first leg 158 and the second leg 160 may extend proximally from the body portion 156. When the manifold 66 is oriented for insertion into the receiver 62, the first leg 158 may be positioned below the second leg 160. The first leg 158 and the second leg 160 may be spaced apart from each other by a gap 162, such as... Figure 21The rear view perspective is best shown. It is understood that potential minor variations may be included in the shown geometry without departing from the above conventions. The housing 74 may include an rim 164 defining an outlet opening 82. The rim 164 may be provided on the first leg 158, and more specifically, on or near the proximal end of the first leg 158. In a conventional sense, the rim 164 may be considered as a proximal guide surface located at the proximal end of the first leg 158. The rim 164 may include a width greater than or equal to its height, such that the outlet opening 82 is non-circular. The rim 164 may be configured to engage with a seal 84.

[0084] Manifold 66 includes arms 148 extending outward from housing 74. The description refers to a pair of arms 148, but it is understood that a single arm may be provided. Figure 16 and Figure 21 Arm 148 is shown as an elongated rib-like structure along a proximal-to-distal direction and includes a width greater than or equal to its thickness. The size and shape of arm 148 are determined to allow it to be movably inserted into an arm groove, thereby defining an opening 64 of receiver 62 (see [link to image]). Figure 18 It should be understood that not all configurations of manifold 66 require the use of arm 148, and manifold designs without arms are also considered. Each arm 148 includes a proximal guide surface 166 configured to engage receiver 62 during insertion of manifold 66 into receiver 62 to facilitate movement of receiver 62 and its components between certain operating positions. The proximal guide surface 166 of arm 148 may be positioned distal to edge 164.

[0085] Manifold 66 includes fasteners 154, and a pair of fasteners 154 are to be described. It should be understood that a single fastener may be provided, and various manifold designs without fasteners are contemplated. Fasteners 154 may be arranged on the second leg 160. Each of the fasteners 154 includes a distal guide surface 168 configured to engage with the jaws of the receiver 62 during insertion of the manifold 66 into and removal of the manifold 66, facilitating movement of the receiver 62. The distal guide surface 168 of the fastener 154 may be positioned proximal to an edge 164 and proximal to a proximal guide surface 166 of the arm 148. At least one of the fasteners 154 and the edge 164 may be spaced apart from each other by a gap 162. More specifically, the edge 164 on the first leg 158 may be spaced apart from the fastener 154 on the second leg 160 by the gap 162. In other words, edge 164 may be located on the first side or the lower side of gap 162, and fastener 154 may be located on the second side or the upper side of gap 162 opposite to the first side or the lower side. Furthermore, when manifold 66 is oriented for insertion into receiver 62, edge 164 is positioned below fastener 154.

[0086] The manifold 66 may include a ridge 152 extending outward from the housing 74. The ridge 152 may be an elongated structure along a proximal-to-distal direction and include a width greater than or equal to its thickness. The ridge 152 may extend outward from at least one of the body portion 156 and / or the first leg 158. Furthermore, the ridge 152 may extend downward from the bottom wall of the body 80. The ridge 152 includes a proximal guide surface 170 configured to engage a pry-lock assembly of the receiver 62 during insertion and removal of the manifold 66 to facilitate movement of the receiver 62 and its components between operating positions. The proximal guide surface 170 of the ridge 152 may be positioned distal to edge 164, distal to distal guide surface 168 of fastener 154, and distal to proximal guide surface 166 of arm 148. In some embodiments, the proximal guide surface 170 is inclined in a proximal direction toward the housing 74 to define a proximal end of the ridge 152. The inclined part can be an inclined surface.

[0087] Manifold 66 includes a locking element 150 extending outward from housing 74. A pair of locking elements 150 are described throughout this disclosure, but it is to be understood that a single locking element may be provided, and various manifold designs without locking elements are contemplated. Figure 16 Each of the locking elements 150 is shown as a shared elongated structure corresponding to a corresponding one in the arm 148. Specifically, each locking element 150 may include a distal guide surface at the distal end of the elongated structure opposite to the proximal guide surface 166 of the arm 148. The locking element 150 may extend outwardly from at least one of the body portion 156 and the first leg 158. The distal guide surface is configured to engage the locking assembly of the receiver 62 after the manifold 66 is inserted into the receiver 62, selectively preventing movement of the manifold 66 distally relative to the receiver 62. The distal guide surface of the locking element 150 may be positioned distally to the edge 164, distally to the distal guide surface 168 of the fastener 154, distally to the proximal guide surface 166 of the arm 148, and distally to the proximal guide surface 170 of the ridge 152. The relative positioning of each of the edge 164, the proximal guide surface 166 of the arm 148, the distal guide surface 168 of the fastener 154, the proximal guide surface 170 of the ridge 152, and / or the distal guide surface of the locking element 150 in the proximal-to-distal direction is adjusted to facilitate precise timing of operation of the complementary components of the receiver 62 when the manifold 66 is inserted into the receiver 62.

[0088] When the manifold 66 is oriented for insertion into the opening 64 of the receiver 62, the head 78 is positioned distal to the body 80. The head 78 may include a first inlet fitting 88a and a second inlet fitting 88b. More specifically, the head 78 may define an auxiliary sleeve 172 extending from the auxiliary opening 174, and the first inlet fitting 88a may extend upward from the upper baffle 176 of the auxiliary sleeve 172. The second inlet fitting 88b extends distally from the cover panel 178 and defines a second inlet orifice (also referred to as a bypass orifice). The auxiliary sleeve 172 is in fluid communication with the manifold volume 76, which is primarily defined by the body 80.

[0089] The fluid characterization module 68 is configured to be removably positioned through the auxiliary opening 111 and supported within the auxiliary sleeve 172. A tray 180 may be provided to facilitate the removable positioning of the fluid characterization module 68 within the auxiliary sleeve 172. In the most general sense, the tray 180 provides a module connector for engagement with the module housing 72 of the fluid characterization module 68. With the tray 180 positioned within the auxiliary sleeve 172, the fluid characterization module 68 is in optical communication with the suction path (and particularly with the inflow of fluid through the first inlet fitting 88a). The tray 180 includes a side 182 and a base portion 184 coupled to the side 182 to collectively define a cavity. The fluid characterization module 68 may be coupled to the base portion 184 and / or disposed within the cavity. More specifically, the fluid characterization module 68 may include a printed circuit board (PCB) assembly 186 whose dimensions and shape are determined to fit the opening of the cavity defined by the module housing 72.

[0090] The tray 180 may also include a sealing member 188 adapted to seal against the auxiliary opening 111 when the tray 180 is within the auxiliary sleeve 172, in order to maintain the suction path through the manifold 66. The sealing member 188 includes a resilient flexible portion 190 located between upper and lower regions 192. Using an input of the control member 194, the flexible portion 190 is configured to resiliently and pivotally move at least a portion of the sealing member 188 away from the auxiliary opening 111 to provide “bleeding” of the suction path as described in Common International Publication No. WO2019 / 0222655, published on 21 November 2019, the entire contents of which are incorporated herein by reference.

[0091] The fluid characterization module 68 includes a sensor assembly 70 configured to be removably inserted through an auxiliary opening 111 and positioned within an auxiliary sleeve 172. The sensor assembly 70 includes emitters 96, 97 configured to emit energy and sensors 98, 99 configured to detect the emitted energy. The emitters 96, 97 and sensors 98, 99 are positioned relative to a suction path. For example, the fluid characterization module 68 may include recesses, pores, or other types of voids through which the suction path is guided. For example, as... Figure 16 As best shown, the detection window 94 may consist of a transparent tube or another component of the tray 180 disposed within the auxiliary sleeve 113. At least one of the transmitters 96 and 97 is positioned on one side of the detection window 94, and at least one of the sensors 98 and 99 is positioned on the other side of the detection window 94. Figure 17 As best shown, emitters 96 and 97 can be coupled to and positioned on opposite sides of PCB assembly 186. In one example, the first emitter 96 is positioned relative to one of the sensors 98 and a recess in PCB assembly 186, and the second emitter 97 is positioned relative to that recess and another of the sensors 99. The first sensor 98 detects transmitted light from the first emitter 96 and scattered light from the second emitter 97. The second sensor 99 detects transmitted light from the second emitter 97 and scattered light from the first emitter 96. The four measurements—two of the transmitted light and two of the scattered light—are provided to controller or processor 60 to execute an algorithm to determine the blood concentration of the fluid. It is understood that the above-described alternative arrangement with two (or three) emitters and four sensors may be included in embodiments of the fluid characterization module 68 disposed on tray 180.

[0092] As understood from the utilization of visible and infrared light, sensors 98 and 99 can exhibit high sensitivity in both the visible and infrared regions of the electromagnetic spectrum. A suitable sensor is the OSRAM SFH3310 phototransistor, which is optimized not only for detecting visible light but also maintains approximately 35% of its maximum sensitivity in the infrared region. It should be noted that the luminosity of the infrared light emitted by the second emitter 97 is relatively greater than that of the scattered green light, and therefore the reduction in the sensitivity of sensors 98 and 99 in the infrared region of the electromagnetic spectrum should not impair the performance of sensors 98 and 99.

[0093] The fluid characterization module 68 may also include at least one integrated circuit. In one embodiment, the fluid characterization module 68 includes an LED driver integrated circuit 196, a photosensor integrated circuit 198, and a microcontroller 200 communicating with the LED driver integrated circuit 196 and the photosensor integrated circuit 198. The LED driver integrated circuit 196 is configured to provide current to drive a first transmitter 96 and a second transmitter 97. The photosensor integrated circuit 198 is configured to transmit signals generated by sensors 98, 99 to the microcontroller 200 (or to the controller 60 or another processor). The microcontroller 200 is configured to convert the signals into the aforementioned values ​​provided to the algorithm to determine the blood concentration of the fluid.

[0094] Fluid characterization module 68 may include communication module 202 such as a transceiver (see...) Figure 27 The communication module 202 may be a component of the microcontroller 200. In one example, the communication module 202 wirelessly transmits data using the Bluetooth Low Energy protocol. The data may be transmitted to the medical waste collection system 40, a mobile device with appropriate software, or any other suitable electronic device for assessing a patient's blood loss.

[0095] The fluid characterization module 68 may also include a battery 204 and a battery management integrated circuit 206. An LED driver integrated circuit 196, a photosensor integrated circuit 198, a microcontroller 200, and / or a communication module 202 may communicate with the battery management integrated circuit 206 and are configured to be powered by the battery 204, which is regulated by the battery management integrated circuit 206. In one embodiment, the battery 204 may be rechargeable. For example, the battery 204 may be charged at a charging station or at a charging port integrated with the medical waste collection system 40. The battery management integrated circuit 206 is configured to manage the charging of the battery 204 and the monitoring of its charge level. For example, the battery management integrated circuit 206 may be configured to send an alarm to be displayed on a control panel 58 or another electronic device when the battery 204 is low on charge.

[0096] Now for reference Figure 18Another embodiment of the fluid characterization module 68 is shown, wherein the module housing 72 is configured to be removably coupled to the head 78 of the manifold 66. The manifold 66 includes a plurality of inlet fittings 88a, 88b, 88c, 88d. Four inlet fittings are shown, but more or fewer are considered. At least one of the inlet fittings 88a, 88b, 88c, 88d may be optically transparent. The module housing 72 includes at least one opening sized to receive at least one of the inlet fittings 88a, 88b, 88c, 88d for coupling the fluid characterization module 68 to the manifold 66. The illustrated embodiment shows a first inlet fitting 88a and a second inlet fitting 88b extending through the opening of the module housing 72. Suction tubes may be coupled to the first inlet fitting 88a and the second inlet fitting 88b located on the distal side of the module housing 72, such that the module housing 72 is positioned between the suction tubes. With the manifold 66 removably positioned within the receiver 62, a suction path is established from the suction tube, through the first inlet fitting 88a and the second inlet fitting 88b, and the manifold volume, up to the receiver 62 and the waste container 46 of the medical waste collection system 40. Therefore, the fluid characterization module 68 optically communicates with the suction path via the optically transparent first inlet fitting 88a and the second inlet fitting 88b. The fluid characterization module 68 can be electronically coupled to the medical waste collection system 40 using an adapter (not shown).

[0097] In some embodiments, manifold 66 is disposable after each use and provides a sterile barrier between the fluid and medical waste collection system 40. Similarly, the detection window 94 of manifold 66 provides a sterile and liquid barrier between the fluid and the electronic components of the fluid characterization module 68. In this arrangement, the fluid characterization module 68 can be a reusable basic component, while the manifold 66 can be a disposable component. Therefore, it may be desirable to integrate the fluid characterization module 68 with or within the components of the medical waste collection system 40. Referring now... Figure 19-22 The fluid characterization module 68 can be integrated with the receiver 62. Specifically, the fluid characterization module 68 can be disposed on the inlet mechanism 208 of the receiver 62. The inlet mechanism 208 includes a suction fitting 210 that defines a suction inlet and is configured to penetrate the seal 84 to be at least partially positioned within the first leg 158 of the manifold 66, such as... Figure 20 As shown in the optimal configuration, when the suction fitting 210 penetrates the seal 84, a sealed fluid communication is provided between the manifold volume 76 and the receiver 62.

[0098] The inlet mechanism 208 may include a first support element 212 and a second support element 214. The first support element 212 and the second support element 214 may be configured to facilitate positioning the manifold 66 within the receiver 62 and supporting the manifold 66 in a fully inserted operating position. The first support element 212 and the second support element 214 may be arc-shaped and defined to mate with the first leg 158. Furthermore, the first support element 212 and the second support element 214 may be spaced from the suction fitting 210 by a distance at least equal to the thickness of the first leg 158. The depth of the space between the first support element 212 and the second support element 214 and the suction fitting 210 may be less than or equal to the depth of the gap 162. When the manifold 66 is inserted into the receiver 62 in a fully inserted operating position, the first support element 212 is seated or positioned within the gap 162, at which point the seal 84 engages with the suction fitting 210. The first support element 212 may also support the manifold 66 to minimize movement of the manifold 66 relative to the receiver 62 when in the fully inserted operating position.

[0099] Unless manifold 66 is in the fully inserted operating position, inlet mechanism 208 can move within receiver 62 to prevent fluid communication between vacuum source 48 and manifold 66. Specifically, inlet mechanism 208 can be movable in a proximal-to-distal direction. As manifold 66 is moved proximally toward the fully inserted operating position, inlet mechanism 208 translates distally, and, for example, during removal of manifold 66, as manifold 66 is moved distally away from the fully inserted operating position, inlet mechanism 208 translates proximally to be misaligned with receiver outlet. Finally, when manifold 66 is in the fully inserted operating position, the suction outlet is aligned with the receiver outlet (see...). Figure 20 This is to provide fluid communication between manifold 66 and waste container 46.

[0100] Since the inlet mechanism 208 defines a portion of the suction path in this embodiment, it is a particularly suitable location for integration with the fluid characterization module 68. Figure 22 Emitters 96 and 97 and sensors 98 and 99 are shown connected to the inlet mechanism 208. Specifically, the first transmitter 96 is connected to the first support element 212, the second transmitter 97 is connected to the second support element 214, the first sensor 98 is connected to the first support element 212, and the second sensor 99 is connected to the second support element 214. The inlet mechanism 208 may also house an LED driver integrated circuit 196, a photosensor integrated circuit 198, and a microcontroller 200. In this embodiment, the fluid characterization module 68 and its electronic components can be powered by the power supply of the medical waste collection system 40, and therefore a battery is not required.

[0101] The suction accessory 210 may define a first window 218 and a second window 220. The first window 218 and the second window 220 are configured to provide optical communication between a first transmitter 96 and a first sensor 98 on the first support element 212 and a second transmitter 97 and a second sensor 99 on the second support element 214. The first window 218 and the second window 220 of the inlet mechanism 208 are further configured to align with the first window 222 and the second window 224 of the manifold 66 in the fully inserted operating position. In other words, the manifold 66 may include a detection window 94, which itself is formed by the first window 222 and the second window 224. The first window 222 and the second window 224 may be optically transparent. Referring now... Figure 21 The first leg 158 of the main body 80 may define a first window 222 on the upper portion 226 of the first leg 158 and a second window 224 on the lower portion 228 of the first leg 158. With the first window 222 and the second window 224 located on the first leg 158, the fastener 154 and the first window 222 are spaced apart by a gap 162. When the manifold 66 is oriented for insertion into the receiver 62, the first window 222 and the second window 224 are positioned below the second leg 160. Furthermore, the first window 222 and the second window 224 may be positioned distal to the edge 164, distal to the proximal guide surface 166 of the arm 148, distal to the proximal guide surface 170 of the ridge 152, distal to the distal guide surface 168 of the fastener 154, and proximal to the distal guide surface of the locking element 150.

[0102] With the manifold 66 in the fully inserted operating position, optical communication is provided between the transmitters 96 and 97 and the sensors 98 and 99. Specifically, light emitted from the first transmitter 96 passes through the first window 218 of the inlet mechanism 208, the first window 222 of the manifold 66, the first leg 158 (including the suction path), the second window 224 of the manifold 66, and the second window 220 of the inlet mechanism 208 to reach the first sensor 98. Similarly, light emitted from the second transmitter 97 passes through the second window 220 of the inlet mechanism 208, the second window 224 of the manifold 66, the first leg 158 (including the suction path), the first window 222 of the manifold 66, and the first window 218 of the inlet mechanism 208 to reach the second sensor 99. During operation of the medical waste collection system 40 with the manifold 66 in the fully inserted operating position, fluid flows through the first leg 158 and through the seal 84, and thus the aforementioned transmitted and scattered light can be detected using the first and second sensors 98 and 99, providing four values ​​to the algorithm. Furthermore, this arrangement results in fluid contacting only the manifold 66 and not the fluid characterization module 68, thereby limiting the need to contaminate the inlet mechanism 208 located inside the medical waste collection system 40 and / or maintain or clean it.

[0103] In some implementations, the radio frequency identification (RFID) tag 216 may be coupled to the manifold 66 and positioned for detection by sensors (e.g., data readers) of the medical waste collection system 40. (See reference) Figure 3-6 , Figure 16 , Figure 18 and Figure 21The RFID tag 216 may be disposed on the upper wall or upper part of the body 80, and it should be understood that the remaining illustrations of the manifold 66 may similarly include the RFID tag 216. More specifically, the RFID tag 216 may be at least partially positioned on the body portion 156, and / or the RFID tag 216 may be at least partially positioned on the second leg 160. The RFID tag 216 may be configured to be detected by a data reader when the manifold 66 is in a first operating position, a second operating position, a third operating position, and / or a fully inserted operating position. If the item cannot be inserted into the fourth or fully inserted operating position for the aforementioned reasons, no data communication is established between the RFID tag 216 and the reader, and the controller 60 may prevent operation of the medical waste collection system 40. In some embodiments, the RFID tag 216 may include a memory storing data for determining whether the manifold 66 can be used with the medical waste collection system 40. The RFID tag 216 transmits data from its memory to the data reader, and the controller 60 of the medical waste collection system 40 performs subsequent actions. For example, the medical waste collection system 40 authenticates the manifold 66, and if successful, the medical waste collection system 40 can operate as intended. In some embodiments, the memory of the RFID tag 216 can store calibration data for transmitters 96, 97 and / or sensors 98, 99. Upon successful authentication, the calibration data is provided to the processor 60 to accurately quantify the blood concentration within the fluid.

[0104] As described, quantifying the blood concentration in fluids from a patient can subsequently facilitate the quantification of blood loss—or QBL analysis—a particularly important metric for healthcare professionals. To quantify the amount of blood loss, the volume of fluid being collected should be determined. In one example, the product of the blood concentration in the fluid and the volume of the fluid is at least approximately equal to the amount of blood loss. One exemplary method for determining the volume of collected fluid is by measuring the fluid volume within the waste container 46 of the medical waste collection system 40. A fluid measurement assembly 47 may be configured such that a floating element, configured to levitate on the fluid, moves along a sensor rod. An interrogation signal is sent along the sensor rod, and a return signal is detected, based on the position of the floating element along the sensor rod. A suitable fluid measurement assembly 47 is disclosed in the aforementioned U.S. Patent No. 7,612,898. The fluid measurement assembly 47 may communicate with a processor 60 and / or wirelessly with another device including a processor. Another exemplary method for determining the volume of collected fluid is by measuring the flow rate of the collected fluid over a known time period. A flow sensor (not shown) can be configured at any suitable location within the suction path. The flow sensor can communicate with processor 60 and / or wirelessly with another device. The flow sensor can be an ultrasonic sensor. Implementations utilizing a flow sensor can provide real-time quantification and display of blood loss on control panel 58 or another electronic device.

[0105] Now for reference Figure 23 A schematic diagram of a workflow for real-time quantification of blood loss is shown, wherein the main program 300 includes an optical acquisition subroutine 302, a volumetric acquisition subroutine 304, and a blood volume calculation subroutine 306. The main program 300 begins at step 308. Step 308 may include initial user operation of the medical waste collection system 40, wherein the manifold 66 is removably inserted into the receiver 62. Step 308 may also include a data reader of the medical waste collection system 40 that detects an RFID tag 216 disposed on the manifold 66, wherein the data transmitted to the data reader reflects that the manifold 66 includes a fluid characterization module 68. In other words, the medical waste collection system 40 identifies the manifold 66 as being for determining the type of blood loss (other manifolds may not have this capability), and therefore should initiate the main program 300. Alternatively, step 308 may include the user selecting on the control panel 58 that a QBL analysis is required.

[0106] In steps 310a and 310b, transmitters 96 and 97 and / or sensors 98 and 99 can be calibrated to normalize optical readings. The power output from transmitters 96 and 97, the sensitivity of sensors 98 and 99, and the transmittance of detection window 94 can drift over time. For example, this drift may be secondary to aging, temperature changes, dirt, component tolerances, etc. Steps 310a and 310b can be performed during a "quiet period" when the system is powered on and / or the medical waste collection system 40 is idle. In one embodiment, steps 310a and 310b include calibrating each of the infrared LEDs and visible LEDs. After the LEDs are turned off and thermal equalization occurs for several seconds, the output from sensors 98 and 99 is stored as a "dark" calibration reading d. After the LEDs are turned on and thermal equalization occurs for several seconds, the output from sensors 98 and 99 is stored as a "bright" calibration reading b. These values ​​are stored in the memory of calibration data database 312. During system operation, any sensor value s read is subsequently converted to an absorbance value A using the following formula:

[0107]

[0108] The execution of steps 310a and 310b yields all subsequent readings related to the light and dark calibration values. Furthermore, the conversion to absorbance transforms the optical readings from the fundamental logarithmic domain to a linear domain that is easier to model. The obtained calibration data can also be provided to the calibration data database 312.

[0109] Alternatively, calibration data may have been previously stored and provided by calibration data database 312. Calibration data database 312 may store calibration data for one or more types of transmitters and one or more types of photodetectors. The model of the transmitter and sensor on a specific fluid characterization module 68 may be data transmitted from RFID tag 216 to the data reader. Calibration data may be written to calibration data database 312. Steps 310a and 310b are optional.

[0110] In step 314, an optical signal delay can be set. Alternatively, a volume signal delay can be set in step 314. Due to the physical distance between the sensor assembly 70 and the fluid measurement assembly 47, there is a delay from the moment the sensor assembly 70 measures the fluid properties to the moment the same fluid enters the waste container 46 and the volume change of that fluid is measured using the fluid measurement assembly 47. Furthermore, since the blood concentration and the collected fluid volume are used together to calculate blood loss, these two signals can be synchronized. In one embodiment, the optical signal is delayed before being multiplied by the volume signal. The obtained delay data can be provided to a delay database 316. Step 314 can be optional. In another embodiment, the delay is updated based on the calculated blood concentration. In this embodiment, step 314 can be considered an initial delay, but the delay is subsequently continuously adjusted based on the calculated blood percentage. This can advantageously improve accuracy by taking into account the high percentage of blood moving slowly through the system, and therefore requires a longer delay value.

[0111] After step 310, the optical acquisition subroutine 302, the volumetric acquisition subroutine 304, and the blood volume calculation subroutine 306 can be executed. In an exemplary embodiment, subroutines 302, 304, and 306 are executed simultaneously. (Continue referring to...) Figure 23The optical acquisition subroutine 302 includes a step 320 to wait for an interrupt. The main program 300 may be in an idle state until a notification (interrupt) from the optical acquisition subroutine 302 and the volume acquisition subroutine 304 indicates that additional data has been generated. The main program 300 uses this data to determine the blood volume for a given period. The main program 300 then enters an idle state until the next interrupt. The optical acquisition subroutine 302 may also include a step 322 to generate optical signals. The optical signals are generated by transmitters 96 and 97 that emit light energy (e.g., visible light and infrared light). The optical acquisition subroutine 302 includes a step 324 to acquire the optical signals. The optical signals, specifically transmitted and scattered light of each of the visible and infrared light, are acquired by sensors 98 and 99. Step 324 may include accumulating the optical signal data and transferring the optical signal data to an optical signal database 326. The optical acquisition subroutine 302 includes an optional step 328 to control the transmitters 96 and 97 and / or an optional step 330 for gain adjustment, to be described in more detail. Step 328 includes monitoring the current through transmitters 96 and 97. If the current increases or decreases (e.g., due to some external influence such as temperature changes), the control signal to the LED driver integrated circuit 196 is adjusted to compensate. The optical acquisition subroutine 302 can be performed at a sampling rate in the range of approximately 800 samples / second to 1000 samples / second, more specifically in the range of approximately 875 samples / second to 925 samples / second, and even more specifically at a sampling rate of approximately 900 samples / second. The conversion of the optical signal can occur at a rate of 10,000 times / second, and the filtered results can be stored at a rate of 900 times / second.

[0112] The volume acquisition subroutine 304 includes a step 332 of generating a volume signal for measuring the fluid volume in the waste container 46, and a step 334 of acquiring the signal. As previously described, the fluid measurement component 47 can determine the fluid volume collected within the waste container 46, and / or a flow sensor can measure the flow rate of the fluid in the suction path to determine the collected fluid volume. The determined volume is provided as volume data, and step 334 may include accumulating the volume data and transferring the volume data to the volume data database 336. The volume acquisition subroutine 304 may be executed at a sampling rate in the range of approximately 900 calc / sec to 1100 calc / sec, more specifically in the range of approximately 975 calc / sec to 1025 calc / sec, and even more specifically at a sampling rate of approximately 1000 calc / sec.

[0113] The blood volume calculation subroutine 306 includes step 338 of receiving accumulated optical signal data from optical signal database 326 and calculating the average optical signal. The average optical signal can be provided to optical output (O / P) database 340. The optical output is the average optical data from sensors 98, 99 over the last time period (e.g., the 1 / 10th of a second). Step 346 is similar except for the volume data. The volume data is then used at step 350 to calculate the flow rate, specifically the difference between the most recent volume measurement and the immediately preceding volume measurement. Flow rate data can be provided to the flow rate O / P database 352. Delayed optical data is determined at step 354 and converted to a percentage blood concentration. This may represent the blood concentration in the fluid during the last time period (e.g., the 1 / 10th of a second). The flow rate is obtained at step 356 and multiplied by the blood concentration to determine the amount of blood loss. The blood volume calculation subroutine 306 can operate at a calculation rate in the range of approximately 5 calc / sec to 15 calc / sec, more specifically in the range of approximately 8 calc / sec to 12 calc / sec, and even more specifically at a calculation rate of approximately 10 calc / sec.

[0114] As described, there may be a delay between the moment when the sensor assembly 70 measures the optical properties of the fluid and the moment when the same fluid enters the waste container 46 to be measured in the fluid measurement assembly 47. Now refer to Figure 23 and Figure 24 Another embodiment of manifold 66 is shown, wherein the volume of the fluid can be determined immediately before the optical properties of the fluid are detected using fluid characterization module 68. Manifold 66 includes at least one baffle 230 that divides manifold 66 into at least a first storage section 232 and a second storage section 234. The first storage section 232 and the second storage section 234 are not in fluid communication with each other. Inlet fitting 88 is selectively in fluid communication with one of the first storage section 232 and the second storage section 234 in a manner to be described. Manifold 66 may include a first outlet fitting 236 defining a first outlet opening and a second outlet fitting 238 defining a second outlet opening, each of the first and second outlet openings being in fluid communication with a corresponding one of the first storage section 232 and the second storage section 234. Each of the first outlet fitting 236 and the second outlet fitting 238 is configured to receive an outlet suction tube, such that manifold 66 operates in a tandem configuration. The outlet suction tube is coupled to fluid characterization module 68. An adapter may be provided to incorporate the outlet suction tube before the fluid flow encounters fluid characterization module 68.

[0115] Manifold 66 includes a first level assembly 240 and a second level assembly 242 associated with a corresponding one of the first storage section 232 and the second storage section 234. Figure 25A first leveling assembly 240 disposed within a first storage section 232 and a second leveling assembly 242 disposed within a second storage section 234 are shown. The first and second leveling assemblies 240 and 242 are configured to function as mechanically actuated valves to provide selective fluid communication between one of the first and second storage sections 232 and an inlet fitting 88, and further to provide selective fluid communication between one of the first and second storage sections 232 and a corresponding outlet fitting 236, 238. The first and second leveling assemblies 240 and 242 include floating elements coupled to mechanisms for pivoting a distal guide 244 and a proximal guide 246 coupled to the distal guide 244. It is contemplated that electronic sensors could be used instead to determine the corresponding level, and / or electronically actuated valves could be used to perform selective alternatives to the suction path.

[0116] The first liquid level assembly 240 and the second liquid level assembly 242 are adjusted to alternate the suction path between the first storage section 232 and the second storage section 234 at a predetermined or determinable liquid level. Since the size of the manifold 66 is fixed, the suction path is effectively alternated between the first storage section 232 and the second storage section 234 when the fluid volume is known. Therefore, once the suction path is alternated, a known volume of fluid is drawn through the fluid characterization module 68, thereby eliminating the aforementioned delay between optical measurement and volume measurement.

[0117] For example, Figure 25A manifold 66 in a first configuration is shown, wherein the distal guide 244 is positioned or tilted such that the second baffle 248 directs fluid into the second reservoir 234. The proximal guide 246 is correspondingly positioned or tilted to block the second outlet opening and allow flow through the first outlet opening. Since a vacuum is drawn on both in the outlet suction pipe, there is no vacuum in the second reservoir 234, but a vacuum exists at the inlet fitting 88 passing through the first reservoir 232. The inflow of fluid is collected in the second reservoir 232, and the floating element of the second level assembly 242 rises accordingly. Due to the interconnection of these mechanisms, once the collected fluid and the floating element in the second reservoir 232 reach a predetermined level, the distal guide 244 and the proximal guide 246 have been displaced to alternating positions. In other words, manifold 66 is moved to a second configuration, in which the distal guide 244 is positioned or tilted to direct fluid into the first storage compartment 232, and the proximal guide 246 is positioned or tilted to allow flow through the second outlet opening. In the second configuration, a vacuum is initiated to empty the second storage compartment 234 via the fluid characterization module 68. Emitters 96, 97 and sensors 98, 99 detect the optical properties of the waste fluid being directed from the second storage compartment 234 to the waste container 46. Simultaneously, additional waste fluid may be accumulating in the first storage compartment 232. Manifold 66 can be selectively alternated or switched between the first and second configurations to repeat the process multiple times as needed or required.

[0118] As previously described, the optical acquisition subroutine 302 includes a gain adjustment step 330. Gain adjustment confirms that blood is highly efficient at absorbing and scattering light, and therefore, as blood concentration increases, the amount of light passing through the blood decreases very rapidly, potentially leading to poor sensitivity and resolution of sensors 98, 99 at high concentrations. For example, if a high gain is selected for sensors 98, 99, they will saturate at lower blood concentration levels, potentially resulting in poor sensitivity and resolution at low concentrations. To overcome this problem, the fluid characterization module 68 advantageously provides on-the-fly adjustment of the gain of one or both of sensors 98, 99. Thus, as blood concentration increases, the gain of sensors 98, 99 can be increased. More specifically, when the light detected by sensors 98, 99 is below a predetermined transmittance threshold, the gain of sensors 98, 99 is increased. Conversely, as blood concentration decreases, the gain of sensors 98, 99 can be decreased. More specifically, when the light detected by sensors 98 and 99 exceeds a predetermined transmittance threshold (or another predetermined transmittance threshold), the gain of sensors 98 and 99 is reduced.

[0119] In one embodiment, a photodetector detects a first light transmittance of the fluid at a first gain level and generates a transmittance signal. This transmittance signal is transmitted to a controller or processor 60. The processor 60 changes the first gain level to a second gain level based on the transmittance signal. The controller or processor 60 determines the blood concentration based on at least one of the first and second gain levels and the transmittance signal. The second gain level may be greater than or less than the first gain level. For example, and referring to… Figure 29 ,Should Figure 29 The light transmittance (U) is shown as a function of time (t). IN ) and gain (U OUT The gain is at the first gain level (U1) and the light transmittance initially increases to exceed the predetermined transmittance threshold (U) at point A. T The controller or processor 60 is configured to adjust the gain level from a first gain level at point C to a second gain level (U2) at point D. The first and / or second gain levels can be stored as a function of the fluid's transmittance or another sensed parameter. Subsequently, the blood concentration decreases further, but then increases, causing the light transmittance to decrease until it falls below a predetermined transmittance threshold at point B. The controller or processor 60 is configured to adjust the gain level from the second gain level at point D to the first gain level at point E. This adjustment of the gain level between the first and second gain levels can occur each time the light transmittance passes the predetermined transmittance threshold. It is understood that more than one predetermined transmittance threshold can exist, allowing more than two different gain levels to be achieved. Furthermore, by employing an analog switch controlled by a microcontroller and multiple resistors, the gain can be selectively changed as needed, such as... Figure 28 As shown.

[0120] If the light transmittance fluctuates around the predetermined transmittance threshold, the gain can be repeatedly adjusted, perhaps over-adjusted. Hysteresis levels can be included to avoid excessive switching of gain levels. Figure 30 An exemplary solution is shown to provide the aforementioned gain adjustment with less "noise," wherein a first predetermined transmittance threshold (U) is utilized. T1 ) and the second predetermined transmittance threshold (U T2More specifically, a second predetermined transmittance threshold is greater than a first predetermined transmittance threshold, such that the threshold for increasing the gain level is higher than the threshold for decreasing the gain level. For example, the gain is at a first gain level, and the light transmittance initially increases and exceeds the first predetermined transmittance threshold at point F. Since the decrease in gain level is limited to a rise in measured light transmittance above or above the second predetermined transmittance threshold, the gain level is not adjusted at point F. The graph shows that the light transmittance further increases to exceed the first predetermined transmittance threshold at point G. The controller or processor 60 is configured to adjust the gain level from the first gain level at point H to the second gain level at point I. Subsequently, the graph shows that the blood concentration further increases and then decreases below the second predetermined transmittance threshold at point J. Since the increase in gain level is limited to a rise in measured light transmittance below the first predetermined transmittance threshold, the gain level is not adjusted at point J. The graph shows that the light transmittance further decreases below the first predetermined transmittance threshold at point K. The controller or processor 60 is configured to adjust the gain level from a second gain level at point L to a first gain level at point M. It is understood that there may be more than two predetermined transmittance thresholds, making more than three different gain levels achievable.

[0121] It is envisioned that sensor assembly 70 may have additional sensors that selectively operate based on detected light transmittance. For example, one or more sensors may be calibrated to low light transmittance, while others may be calibrated to high light transmittance. Some sensors may be set to default operation. If the detected light transmittance is below a predetermined transmittance threshold, controller 60 may selectively activate the sensors calibrated to low light transmittance. If the detected light transmittance returns to or increases above the predetermined transmittance threshold, controller 60 may selectively activate the sensors calibrated to high transmittance. Alternatively, the brightness of emitters 96, 97 may be adjusted based on the detected light transmittance. For example, if the detected light transmittance decreases below a predetermined transmittance threshold, controller 60 may increase the brightness of the light emitted from emitters 96, 97 (or activate a brighter emitter). Conversely, if the detected light transmittance returns to or increases above the predetermined transmittance threshold, controller 60 may decrease the brightness of the light emitted from emitters 96, 97 (or deactivate a brighter emitter).

[0122] Now for reference Figure 31The blood management system 39 may include a medical waste collection system 40, a sponge system 41, and a user interface 43. In its most general sense, the blood management system 39 is used to provide real-time quantification of patient blood loss, thereby making full use of systems 40, 41, and 43 to account for different methods of presenting blood in the operating room. The compilation of data from systems 40, 41, and 43 facilitates the provision of real-time and accurate quantification of patient blood loss displayed on the user interface 43. Data may be optionally sent to the patient's electronic medical record (EMR) 45. This increased accuracy provides more reliable visual and audible alerts to attending physicians in the event of excessive blood loss.

[0123] The blood management system 39 includes a medical waste collection system 40, which is described throughout this disclosure and is referred to herein by reference. The medical waste collection system 40 separates blood from other mainstream fluids, and subsequent volumetric measurements are used for blood loss calculation. Alternatively or concurrently, the medical waste collection system 40 may receive input from the user indicating only the blood being aspirated. For example, the volume of fluid after amniotic fluid collection is known to be called tare. A fluid characterization module 68 is integrated with or removably coupled to a manifold 66 and / or integrated with the medical waste collection system 40 via any one or more of the embodiments described herein.

[0124] The medical waste collection system 40 can perform QBL analysis and wirelessly transmit blood volume data to the user interface 43. Alternatively, the user interface 43, another device such as a mobile device or a remote server, can receive the data described herein and execute algorithms to perform QBL analysis. The medical waste collection system 40 communicates electronically with the user interface 43. Exemplary modes of electronic communication include Bluetooth Low Energy and a local area network (LAN), in which both the medical waste collection system 40 and the user interface 43 are wirelessly connected.

[0125] The sponge system 39 is configured to determine the amount of blood loss contained in an absorbent article such as a surgical sponge. An exemplary sponge system is sold by Stryker Corporation (Karamazoo, Michigan) under the trademark SurgiCount. The sponge system 31 includes a support with onboard components for calculating blood loss parameters. The support includes one or more detection devices and one or more mass measuring devices. In an exemplary embodiment, the detection device is a barcode reader, and the mass measuring device is a weighing sensor.

[0126] In another embodiment, the mass measuring device may be a container assembly for absorbent articles, having an embedded weighing sensor for weighing the absorbent articles. The container assembly may also include electronics configured to detect absorbent articles within the container assembly. When absorbent articles are detected, information is transmitted to a processor to identify them using part numbers and dry weights from a pre-programmed dataset.

[0127] When indicating blood loss data, a bag or other storage product can be physically supported on or by a mass measuring device. The bag may include a scannable code associated with its part number and dry weight. When absorbent material is introduced into the bag, the scannable code placed on the absorbent material is scanned by a barcode reader. A database includes part numbers and the dry weight of the absorbent material. The mass measuring device determines the total weight and subtracts the dry weight of the absorbent material to calculate the weight of the absorbed fluid. The amount of blood loss absorbed can be calculated using the weight of the blood and its known density. The sponge system 41 communicates electronically with the user interface 43, and the sponge system 41 can transmit the blood loss data wirelessly or via a wired connection to the user interface 43.

[0128] In another implementation, the accuracy of dry weight can be improved by measuring the mass of the bag or absorbent article during the manufacturing process, for example, by storing the measured mass in a pre-programmed dataset of the RFID tag 216. The measured mass can be based on the measured batch or package average mass.

[0129] User interface 43 serves as a hub for providing emergency patient information to attending medical staff. Blood loss can be displayed in real-time on control panel 58 and / or user interface 43 throughout the process. Blood loss can also be displayed as a graphical representation of a period of time since the start of the procedure. In an exemplary embodiment, user interface 43 is a tablet computer with a touchscreen display used to display all applicable information, such as aspirated blood loss, absorbed blood loss, alarms, warnings, and all other critical information. For example, the blood loss rate can be used to trigger an alarm to warn healthcare workers of a high blood loss rate and the potential for postpartum hemorrhage. User interface 43 displays the patient's total blood loss by combining all relevant data. Alarms or warnings can be based on thresholds or guidelines wirelessly pushed to user interface 43. Thresholds can be predetermined by the manufacturer, implemented based on institution protocols, or obtained through clinical or other guidelines. Guidelines can be based on external clinical organizations, AI decisions from clinical data mining, or other sources. Additional alarms can be generated based on the blood loss rate. Furthermore, the touchscreen display is configured to receive user input, particularly qualitative blood loss-related input from attending medical staff. Qualitative input may include an estimate of blood loss as visualized on the floor or other absorbent materials.

[0130] If known, the volume of the irrigation fluid used during the procedure can also be input to the touchscreen display. Alternatively, the irrigation fluid can be gravity-pressurized by a system capable of measuring and / or transmitting the mass or volume of the fluid used. The initial volume of the irrigation fluid can be input, measured, and / or scanned. The irrigation system may include a weighing sensor that measures the current mass used to calculate the volume of the irrigation fluid used. Alternatively, if an electronic pump is used to deliver the irrigation fluid, the pump can generate and transmit data indicating the volume of the irrigation fluid used.

[0131] 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 terminology used is intended to have a descriptive nature rather than a limiting nature. Based on the foregoing teachings, many modifications and variations are possible, and the invention may be practiced in ways other than those specifically described.

[0132] Some implementation schemes can be described with reference to the following exemplary clauses:

[0133] Clause 1—A manifold configured to be removably coupled to a receiver of a medical waste collection system, the medical waste collection system including a sensor assembly of a fluid characterization module and a vacuum source configured to generate a suction path for fluid, the manifold including: a housing including a first leg defining an outlet opening and a detection window, a second leg spaced apart from the first leg to define a gap, and an inlet fitting configured to be removably coupled to a suction tube, wherein the detection window is configured to optically communicate with the sensor assembly when the manifold is removably inserted into the receiver.

[0134] Clause 2—The manifold as described in Clause 1, wherein the detection window comprises a first window disposed on the upper part of the first leg and a second window disposed on the lower part of the first leg.

[0135] Clause 3—A manifold as described in Clause 1 or Clause 2, wherein the outlet opening is located near the detection window.

[0136] Clause 4—A manifold as described in any of Clauses 1-3, wherein the manifold further includes an arm extending outwardly from the first leg, the proximal guiding surface of the first leg being located distal to the detection window.

[0137] Clause 5—A manifold as described in any of Clauses 1-4, wherein the manifold further includes a fastener disposed on a second leg, the distal guide surface of the fastener being positioned proximal to the detection window.

[0138] Clause 6—The manifold as described in Clause 5, wherein the fastener and the inspection window are separated by a gap.

[0139] Clause 7—A manifold as described in any of Clauses 1-6, wherein the detection window is configured to be positioned below the second leg when the manifold is oriented for insertion into a receiver of a medical waste collection system.

[0140] Clause 8—A manifold as described in any of Clauses 1-7, wherein the manifold further includes a ridge extending from the first leg, the proximal guide surface of the ridge being positioned distal to the detection window.

[0141] Clause 9—A manifold as described in any one of Clauses 1-8, wherein the manifold further includes a radio frequency identification (RFID) tag at least partially disposed on the second leg, and the manifold includes a storage unit for storing data.

[0142] Clause 10—A method for determining the amount of blood loss in fluid collected via a suction path generated by a medical waste collection system, the method comprising the steps of: receiving signals from a photodetector; executing an optical acquisition subroutine in which, based on the signals, a blood concentration in the fluid is determined; executing a volume acquisition subroutine in which, a volume acquisition subroutine is measured or determined; and executing a blood volume calculation subroutine in which, based on the blood concentration and the volume of the collected fluid, the amount of blood loss is determined.

[0143] Clause 11—The method as described in Clause 10, wherein the method further comprises the step of executing a main program including an optical acquisition subroutine, a volume acquisition subroutine, and a blood volume calculation subroutine, the main program further comprising a calibration subroutine in which a photodetector is calibrated based on at least two different wavelengths of light.

[0144] Clause 12—The method as described in Clause 10 or Clause 11, wherein the blood volume calculation subroutine further includes the step of adjusting the gain of the photodetector based on light and in relation to a predetermined transmittance threshold.

[0145] Clause 13—The method described in any of Clauses 10-12, wherein the blood volume calculation subroutine further includes the step of calculating the flow rate along the aspiration path.

[0146] Clause 14—A computer program product configured to perform the method described in any one of Clauses 10-13.

[0147] Clause 15—A medical waste collection system for collecting fluid through a manifold, the medical waste collection system comprising: a waste container; a vacuum source configured to create a suction path; a receiver coupled to the waste container and defining an opening, the manifold being configured to be removably inserted into the opening; a fluid characterization module including a sensor assembly configured to detect optical properties of the fluid within the suction path; a processor communicating with the sensor assembly and configured to receive blood concentration signals from the sensor assembly for determining the amount of blood loss in the fluid; and a fluid measurement assembly coupled to the waste container and communicating with the processor, the fluid measurement assembly being configured to measure the volume of the collected fluid, wherein the processor is configured to receive a fluid volume signal from the fluid measurement assembly, and values ​​associated with the blood concentration signal and the fluid volume signal contributing to the quantification of blood loss.

[0148] Clause 16—A medical waste collection system as described in Clause 15, wherein the medical waste collection system further includes a flow sensor in communication with a controller configured to measure the flow rate of the collected fluid, the controller being configured to receive a flow signal from the fluid measurement component, the value associated with the blood concentration signal and the flow signal contributing to the quantification of blood loss.

[0149] Clause 17—A medical waste collection system as described in Clause 15 or 16, wherein the medical waste collection system further includes a mobile device comprising a processor.

[0150] Clause 18—A medical waste collection system for collecting waste liquid material passing through a manifold, the medical waste collection system comprising: a waste container; a vacuum source configured to provide a vacuum over the waste container; a receiver coupled to the waste container and defining an opening, the manifold being configured to be removably inserted into the opening, wherein the receiver includes an inlet mechanism movable in a proximal and distal direction and a sensor assembly coupled to the inlet mechanism, the sensor assembly being configured to detect optical properties of fluid passing through the manifold.

[0151] Clause 19—A medical waste collection system as described in Clause 18, wherein the medical waste collection system further includes a processor that communicates with the sensor assembly and is configured to receive sensor signals from the sensor assembly indicating the characteristic and is further configured to determine the blood concentration in the fluid by means of these signals.

[0152] Clause 20—A medical waste collection system as described in Clause 18 or 19, wherein the inlet mechanism further includes a first support element spaced apart from the suction inlet, and the sensor assembly includes a first transmitter disposed on the first support element.

[0153] Clause 21—A medical waste collection system as described in Clause 20, wherein the inlet mechanism further includes a second support element spaced apart from the suction inlet and positioned relative to the first support element, and the sensor assembly includes a first sensor disposed on the second support element.

[0154] Clause 22—A medical waste collection system as described in Clause 21, wherein the sensor assembly includes a second transmitter disposed on a second support element.

[0155] Clause 23—A medical waste collection system as described in Clause 22, wherein the sensor assembly includes a second sensor disposed on a first support element.

[0156] Clause 24—A medical waste collection system as described in any of Clauses 18-23, wherein the inlet mechanism is configured to move in a proximal to distal direction during insertion of the manifold into and removal of the manifold from the receiver.

[0157] Clause 25—A medical waste collection system for collecting waste fluid material passing through a manifold, the medical waste collection system comprising: a waste container; a vacuum source configured to provide a vacuum over the waste container; a receiver coupled to the waste container and defining an opening, the manifold being configured to be removably inserted into the opening; and a receiver outlet including an inlet mechanism movable in a proximal and distal direction; and a sensor assembly coupled to the receiver and arranged relative to the manifold to detect characteristics of the fluid passing through the manifold, the characteristics indicating blood concentration within the fluid.

[0158] Clause 26—A medical waste collection system for quantifying blood loss, the medical waste collection system comprising: a waste container; a vacuum source configured to provide a vacuum over the waste container; a fluid characterization module including a photodetector configured to detect a first light transmittance of a fluid at a first gain level and generate a transmittance signal; and a processor communicating with the photodetector and configured to: receive the transmittance signal from the photodetector; change the first gain level to a second gain level based on the transmittance signal; and determine the blood concentration in the fluid based on at least one of the first gain level and the second gain level and the transmittance signal.

[0159] Clause 27—A medical waste collection system as described in Clause 26, wherein the transmittance signal is higher than a first predetermined transmittance threshold and the second gain level is lower than the first gain level.

[0160] Clause 28—A medical waste collection system as described in Clause 26 or 27, wherein the transmittance signal is below a first predetermined transmittance threshold and the second gain level is greater than the first gain level.

[0161] Clause 29—A medical waste collection system as described in Clause 27 or 28, wherein the processor is further configured to determine whether the transmittance signal is higher or lower than a second predetermined transmittance threshold less than a first predetermined transmittance threshold, and when the transmittance signal is lower than the second predetermined transmittance threshold, to change the second gain level to the first gain level or the third gain level.

[0162] Clause 30—A manifold for quantifying blood within a fluid, the manifold being configured to be in fluid communication with a vacuum source and sensor assembly of a medical waste collection system, the manifold comprising: a housing including a baffle separating a first reservoir and a second reservoir; an inlet fitting defining a first outlet opening in fluid communication with the first reservoir and a second outlet opening in fluid communication with the second reservoir; a first leveling assembly disposed within the first reservoir; a second leveling assembly disposed within the second reservoir; a distal guide; and a proximal guide, wherein the distal guide and the proximal guide are configured to be switched to selectively direct fluid into one of the first and second reservoirs and selectively prevent fluid from being aspirated through the same reservoir in the first and second reservoirs.

[0163] Clause 31—A manifold as described in Clause 30, wherein the distal guide is connected to the first level assembly and the second level assembly.

[0164] Clause 32—A manifold as described in Clause 30 or Clause 31, wherein the proximal guide is operatively coupled to the distal guide.

[0165] Clause 33—A manifold as described in Clause 30, wherein the distal guide and the proximal guide are electronically controlled valves.

[0166] Clause 34—A manifold for quantifying blood within a fluid, the manifold being configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, the manifold comprising: a housing including a head including an inlet fitting configured to be removably coupled to a suction tube for drawing fluid through the manifold under the influence of a vacuum from the vacuum source; a body coupled to the head and including an outlet opening defining an offset relative to the longitudinal axis of the manifold; and a filter element disposed within the housing, wherein at least a portion of the head is optically transparent to include a detection window configured to be positioned between a detector and a transmitter of an optical sensor assembly.

[0167] Clause 35—A manifold as described in Clause 34, wherein the housing defines a manifold volume and further includes a protrusion defining a reservoir below the manifold volume, the protrusion including a detection window.

[0168] Clause 36—A manifold as described in Clause 34 or Clause 35, wherein the protrusion includes a coupling feature configured to be removably coupled to a fluid characterization module including an optical sensor assembly, and optionally, the coupling feature includes at least one guide rail configured to slidably engage a slot of the fluid characterization module.

Claims

1. A manifold for quantifying blood within a fluid and configured to be removably inserted into a manifold receiver of a medical waste collection system, the medical waste collection system including a vacuum source, the manifold comprising: A housing comprising a body portion, a first leg, a second leg, and an inlet fitting, the first leg extending from the body portion and including an edge defining an outlet opening, the second leg extending from the body portion and spaced apart from the first leg to define a gap, the inlet fitting being configured to be removably connected to a suction tube for drawing fluid through the manifold under the influence of a vacuum source, wherein the housing defines a manifold volume and further includes a protrusion defining a reservoir below the manifold volume; and The filter element is disposed within the housing; At least a portion of the protrusion is optically transparent to include a detection window configured to be positioned between a transmitter and a detector of an optical sensor assembly, and the transmitter and the detector are configured to detect the optical properties of fluid passing through the detection window.

2. The manifold as claimed in claim 1, wherein, The housing also includes a body and a head. The body includes the first leg and the second leg. The head is connected to the body and includes the inlet fitting. The head includes the detection window.

3. The manifold as claimed in claim 1, wherein, The protrusion includes a coupling feature configured to be removably coupled to a fluid characterization module including the optical sensor assembly.

4. The manifold as claimed in claim 3, wherein, The connection feature includes at least one guide rail configured to slidably engage a slot of the fluid characterization module.

5. The manifold as claimed in any one of claims 1-4, wherein, The width of the protrusion is no more than three-quarters of an inch.

6. The manifold as claimed in any one of claims 1-4, wherein, The filter element is a first filter element disposed within the manifold volume, and the manifold also includes a second filter element disposed within the reservoir.

7. The manifold as claimed in claim 6, wherein, The manifold also includes a straw, which has a first end located near the bottom of the reservoir and a second end located within the manifold volume.

8. The manifold as claimed in claim 7, wherein, The straw extends through the second filter element.

9. The manifold as claimed in any one of claims 1-8, wherein, The manifold also includes a flow guide disposed within the housing, the flow guide including a geometry configured to provide a tortuous path to the fluid within the manifold.

10. The manifold as claimed in claim 9, wherein, The flow guide includes a baffle positioned above the detection window and defining a liquid inlet configured to facilitate the accumulation of the fluid within the housing, during which gas within the fluid is separated from liquid within the fluid.

11. The manifold as claimed in claim 10, wherein, The flow guide also defines a gas inlet positioned above the liquid inlet.

12. The manifold as claimed in claim 11, wherein, The flow guide also defines a fluid outlet communicating with each of the liquid inlet and the gas inlet.

13. The manifold as claimed in any one of claims 9-12, wherein, The filter element is positioned closer to the outlet opening relative to the flow guide.

14. The manifold as claimed in any one of claims 9-12, wherein, The flow guide is positioned closer to the outlet opening relative to the filter element.

15. The manifold as claimed in any one of claims 1-14, wherein, The manifold also includes a radio frequency identification (RFID) tag disposed on the housing and including a memory that indicates the data stored in the manifold for use with the optical sensor assembly used to quantify blood loss.

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