Quantification of blood loss using medical waste collection systems

Abstract

Quantifying blood loss using a medical waste collection system including a manifold and a removably coupled receiver. The manifold and / or medical waste collection system are coupled to a fluid characterization module having a sensor assembly for detecting a characteristic indicative of blood concentration in the fluid. The sensor assembly can include an emitter and a sensor for detecting light transmitted and scattered by the fluid in the suction path or detection window. The first emitter can be a visible light LED, and the second emitter can be an infrared LED. The fluid directing member can provide a tortuous path within the manifold to facilitate separation of gas and liquid in the fluid. Quantifying blood loss volume can include determining the blood concentration in the fluid and determining the volume of collected fluid. The gain of the sensor can be adjusted based on the transmittance of the collected fluid.

Description

[Technical Field]

[0001] (Claiming priority) This application claims priority and all interests of U.S. Provisional Patent Application No. 63 / 112,382, filed November 11, 2020, which in its entirety constitutes part of this specification by reference. [Background technology]

[0002] Some surgical procedures produce liquid, semi-solid, and / or solid waste materials as byproducts. Liquid waste materials may include bodily fluids and / or irrigation solutions at the surgical site, while solid and semi-solid waste materials may include tissue fragments and / or pieces of surgical materials. Medical waste, regardless of its phase, should preferably be collected without contaminating the surgical site and without causing biological hazards to the medical suite in which the procedure is performed.

[0003] Medical waste can be removed from the surgical site through a suction tube under the influence of a vacuum provided by a medical waste collection system. One exemplary medical waste collection system is marketed under the trade name Neptune by Stryker Corporation (Kalamazoo, Michigan), and certain versions of the medical waste collection system are disclosed in U.S. Patent Application Publication No. 2005 / 0171495, published on 4 August 2005, International Publication No. 2007 / 070570, published on 21 June 2007, and International Publication No. 2014 / 066337, published on 1 May 2014, all of which are jointly owned by the applicant and constitute part of this specification by reference. A manifold can be provided to facilitate the connection of a suction tube to the medical waste collection system. The manifold can be disposable.

[0004] Collected liquid waste material may contain blood, which may be present in the aspiration pathway along with other bodily fluids such as interstitial fluid and mucus. Intraoperative blood loss assessment may be used to monitor the patient's health. Excessive blood loss can indicate surgical complications, and blood loss assessment facilitates the evaluation of the need for transfusions. Childbirth is of particular interest, as obstetric hemorrhage is a major cause of maternal morbidity, with 11 percent of maternal deaths in the United States reported to be due to postpartum hemorrhage. Early detection of obstetric hemorrhage can significantly reduce maternal morbidity. There is growing support among clinicians and regulatory bodies for increasing the use and accuracy of methods and tools for quantifying blood loss, particularly in vaginal and cesarean section deliveries where postpartum hemorrhage is a concern.

[0005] It is known that intraoperative blood loss can be estimated by visual inspection of absorbent materials (e.g., sponges, surgical gowns, bedding, or drapes), measurement of absorbent materials using weighing instruments, and / or by measuring a graduated collection container under the operating table. Additionally or alternatively, blood loss estimation may include visually observing the color of the blood- and non-blood mixture in the waste container after aspiration from the surgical site.

[0006] The aforementioned method may provide near-optimal accuracy, and a considerable delay may exist between the determination of blood loss and the actual blood loss when using this method. Therefore, it is desirable to provide an improved system, apparatus, and method for accurately and rapidly quantifying blood loss during surgical procedures. [Overview of the project]

[0007] Without limiting the effects of the outline of the invention, and within the scope of the invention as defined by the claims and the items contained herein, 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 section for collecting and storing waste material. A vacuum source is configured to provide 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 a manifold.

[0008] The fluid characterization module is configured to facilitate the quantification of blood concentration in a fluid drawn through a medical waste collection system under the influence of suction. The fluid characterization module includes a sensor assembly and may further include a module housing. The fluid characterization module is free-floating and can be coupled to a dongle or integrated with a receiver. The sensor assembly includes an emitter(s) and a sensor(s). The emitter is configured to emit energy, and the sensor is configured to detect the emitted energy. The emitter may be a light-emitting diode (LED), and the sensor may be a photodetector. The emitter and sensor may be configured to be positioned opposite a detection window. The first emitter may be an infrared LED, and the second emitter may be a visible light LED. The infrared LED may be configured to emit light having wavelengths in the range of approximately 700 nanometers (nm) to 1000 nm, more specifically in the range of 750 nm to 850 nm, and even more specifically in the range of 770 nm to 810 nm. The visible light LED can be configured to emit light with wavelengths in the range of approximately 400nm to 600nm, more specifically in the range of 550nm to 600nm, and even more specifically in the range of 570nm to 580nm. The visible light LED can be a green LED. The sensor detects the emitted light, more specifically, the light after it has been transmitted or scattered through the fluid passing through the detection window. The detected intensity of the transmitted or scattered light may indicate the transmittance, opacity, and / or other physical properties of the fluid. The four measurements, namely two measurements of transmitted light and two measurements of scattered light, are values ​​provided to the processor to run an algorithm to determine the blood concentration of the fluid passing through the detection window.

[0009] The manifold includes a housing that defines the manifold volume. The manifold may include a head connected to a trunk that cooperates to define the manifold volume. The head may include an inlet fitting configured to removably receive at least one suction tube. The trunk may define an outlet opening that communicates fluid with the manifold volume and the inlet fitting. A seal may be connected to the housing and sized to cover the outlet opening. A filter element may be located within the manifold volume. The outlet opening may be offset from the longitudinal axis of the manifold and may be configured to function as a valve actuation for a rotatable valve in a medical waste collection system. The manifold may include a body and first and / or second legs extending proximal from the body. The first and second legs may be spaced apart from each other by a gap. The manifold may include arms, locking elements, spines, and / or catches. A rim may be located on the first leg and may define the outlet opening. Each arm includes a proximal-oriented surface positioned distal to the rim. The distal-oriented surface of the catch can be positioned proximal to the rim and proximal to the proximal-oriented surface of the arm. The proximal-oriented surface of the spine can be positioned distal to the rim, distal to the distal-oriented surface of the catch and distal to the proximal-oriented surface of the arm. The distal-oriented surface of the locking element can be positioned distal to the rim, distal to the distal-oriented surface of the catch, distal to the proximal-oriented surface of the arm and distal to the proximal-oriented surface of the spine. All internal features of the manifold may include a trunk having an offset outlet opening, or a trunk having a first leg and a second leg.

[0010] At least a portion of the manifold housing is optically transparent and defines a detection window. The detection window is configured to be positioned adjacent to or between the emitter and sensor of a sensor assembly. The emitter and sensor of the sensor assembly are configured to detect the optical properties of the fluid passing through the detection window. The portion of the housing defining the detection window can be formed from a transparent material. The manifold may include a projection. The projection may be located on the head and extend longitudinally from proximal to distal. The projection may include a coupling feature configured to engage with the module housing of a fluid characterization module. The coupling feature may be a rail sized to be slidably positioned by a slot defined by the module housing. The projection may define a reservoir configured to facilitate the separation of gases in the fluid from liquids 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 in the reservoir provides a short period during which gases can separate from liquids.

[0011] The manifold may further include a fluid directional member located within the housing. The fluid directional member includes various geometric shapes configured to provide a meandering path for the fluid within the manifold. The fluid directional member may be located within the manifold volume and at least partially within the head. The geometric shapes cooperate with the internal geometry of the housing to define fluid, liquid, and gas flow paths. Gas flow paths may be located near the top surface of the manifold, and liquid flow paths may be located near the bottom surface of the manifold. Liquid flow paths may be at least partially defined by a reservoir section including a detection window. The fluid directional member includes a first barrier and a second barrier, which can define a gas inlet, a gas channel, a liquid channel, and a fluid outlet. The second barrier and the manifold housing cooperate to define a liquid inlet between the manifold volume and the reservoir section. The first barrier is configured to provide a meandering path for the fluid entering the manifold through the inlet fitting. The separated gas is drawn in through the gas channel and fluid outlet, passing through the filter element and outlet opening. The separated liquid can be simultaneously drawn in through the liquid inlet from the vacuum provided by the medical waste collection system. The separated liquid can be further drawn in through a liquid reservoir section including a detection window, a liquid channel, and a fluid outlet. The liquid and gas channels can be joined before the fluid outlet.

[0012] The fluid directionor can be positioned proximal to the filter element. The fluid directionor can define a detection window. The fluid characterization module can be placed within the manifold. The fluid directionor may include at least one directional opening that communicates with a longitudinally extending lateral channel within the manifold. The fluid directionor can define a central channel that communicates with a liquid reservoir and a gas inlet near the proximal end of the manifold. The filter element is non-cylindrical and can be positioned in a stacked configuration with the fluid directionor. The filter element may be semi-cylindrical with a flat surface positioned to be supported on the upper surface of the fluid directionor.

[0013] The manifold may include a second filter element. The second filter element may be located within the reservoir. A straw may be located at least partially within the reservoir. The vacuum provided by the system is drawn through the straw, drawing the liquid from the reservoir through the first end of the straw against gravity. The liquid is drawn through the straw and further through a detection window defined by a second projection. The straw may extend through the second filter element.

[0014] The head can define an accessory sleeve extending from an accessory opening. A first inlet fitting can extend upward from the upper barrier of the accessory sleeve. The accessory sleeve is in fluid communication with the manifold volume. The fluid characterization module is configured to be removablely positioned through the accessory opening and supported within the accessory sleeve. The tray can facilitate the removable positioning of the fluid characterization module within the accessory sleeve to optically communicate with the suction path and, in particular, with the inflow of fluid through the first inlet fitting. The fluid characterization module may include a printed circuit board (PCB) assembly sized and molded for the opening of the tray cavity. The fluid characterization module includes a sensor assembly. The fluid characterization module may further include an LED driver integrated circuit, a photosensor integrated circuit, and a microcontroller that communicates with the LED driver integrated circuit and the photosensor integrated circuit, as well as one or more of a communication module, a battery, and a battery management integrated circuit.

[0015] Radio frequency identification (RFID) tags can be attached to a manifold and positioned to be detected by a data reader in a medical waste collection system. The RFID tag transmits data from its memory to the data reader, and the medical waste collection system's controller performs the resulting action. The RFID tag's memory can store calibration data for the emitter and / or sensor.

[0016] The fluid characterization module can be integrated with the receiver. The fluid characterization module can be located in the inlet mechanism of the receiver. The inlet mechanism includes a suction fitting configured to penetrate a seal and be at least partially located within the manifold. The emitter and sensor can be connected to the inlet mechanism and positioned relative to a detection window on the first leg of the trunk. Embodiments of the fluid characterization module can be used individually or in combination. The manifold and receiver can accommodate separate fluid characterization modules. The outputs from each of the fluid characterization modules can be compared and / or combined via a controller or processor to evaluate or improve the accuracy of determining blood concentration in the fluid. The output from one of the fluid characterization modules can be used to facilitate the calibration of another of the fluid characterization modules.

[0017] The fluid characteristics evaluation module can provide adjustment for the gain of one or both of the sensors. When the light detected by the sensor falls below a predetermined transmittance threshold, the sensor gain can be increased. When the light detected by the sensor rises above a predetermined transmittance threshold, the sensor gain can be decreased. The sensor assembly may include additional sensors that operate selectively based on the detected light transmittance. The emitter brightness can be adjusted based on the detected light transmittance.

[0018] The blood management system can include a medical waste collection system, a sponge system, and a user interface. The data can be transferred to the patient's electronic medical record (EMR). The medical waste collection system can perform a QBL analysis and wirelessly transmit blood volume data to the user interface. Additionally or alternatively, another device such as a mobile device or a remote server can receive the data described herein and perform an algorithm to conduct a QBL analysis. The sponge system is configured to determine the volume of blood loss contained within an absorbent article such as a surgical sponge. The user interface functions as a hub for providing acute patient information to medical staff. The volume of blood loss can be displayed in real-time on a control panel and / or the user interface throughout the procedure. The volume of blood loss can also be displayed as a graph plot over time since the procedure began. The user interface can trigger alarms, warnings, and all other important information. The alarm or warning can be based on thresholds or guidelines pushed wirelessly to the user interface.

[0019] The advantages of the present disclosure will be better understood and thus readily appreciated when considered in connection with the accompanying drawings and the following detailed description.

Brief Description of the Drawings

[0020] [Figure 1] FIG. is a perspective view of a medical waste collection system in a state where a manifold is removably inserted into a receiver of the medical waste collection system. [Figure 2] FIG. 1 is a cross-sectional view of the medical waste collection system schematically showing a certain optional component of the medical waste collection system. [Figure 3] FIG. is a perspective view of a manifold showing a fluid property evaluation module including a sensor assembly. [Figure 4]The manifold is an exploded view of the manifold of FIG. 3, including a head, a fluid-directing member, a filter element, and a trunk. [Figure 5] It is a cross-sectional perspective view of the manifold of FIG. 3 along cutting line 5-5. [Figure 6] It is a cross-sectional elevation view of the manifold of FIG. 3 along cutting line 6-6. [Figure 7] It is a cross-sectional elevation view of another manifold in which the first barrier of the fluid-directing member is positioned proximal to the inlet joint of the head. [Figure 8] It is an exploded view of another manifold in which the fluid-directing member is positioned proximal to the filter element. The fluid property evaluation module can be arranged inside the manifold. [Figure 9] It is a cross-sectional elevation view of the manifold of FIG. 8 along cutting line 9-9. [Figure 10] It is an exploded view of another manifold in which the fluid flow is filtered by the filter element before encountering the fluid-directing member. [Figure 11] It is a cross-sectional elevation view of the manifold of FIG. 10 along cutting line 11-11. [Figure 12] It is a perspective view of another manifold in which a protrusion defining a liquid reservoir extends downward from the head of the manifold. [Figure 13] It is an exploded view of one modification of the manifold of FIG. 12 in which a second filter element and a straw are arranged inside the liquid reservoir. [Figure 14] It is a cross-sectional elevation view of the manifold of FIG. 13 along cutting line 14-14. [Figure 15] It is a cross-sectional elevation view of another modification of the manifold of FIG. 12 in which the straw extends through the second filter element. [Figure 16] It is a perspective view of another manifold through which the fluid property evaluation module can be inserted through the accessory opening of the manifold. [Figure 17] It is a perspective view of the fluid property evaluation module of FIG. 16. [Figure 18]A perspective view of the receiver of a medical waste collection system and another manifold configured to be detachably inserted into the receiver. A fluid characterization module can be connected to the manifold. [Figure 19] This is a perspective view of the receiver of a medical waste collection system, and another manifold that is detachably inserted into the receiver. [Figure 20] This is a cross-sectional view of the receiver and manifold in Figure 19 along the cutting line 20-20. [Figure 21] Figure 19 is a rear perspective view of a portion of the manifold, where the first leg of the manifold defines a detection window configured to be positioned near the receiver's sensor assembly. [Figure 22] This is a perspective view of the receiver's inlet mechanism. The sensor assembly is connected to the inlet mechanism. [Figure 23] This is a schematic diagram of the electronic components of a fluid properties evaluation module and, optionally, a medical waste collection system for quantifying blood loss. [Figure 24] This is a perspective view of another manifold in which distal fluid directing members and proximal fluid directing members can operate between a first fluid reservoir and a second fluid reservoir based on the fluid levels in the first and second reservoirs. [Figure 25] Figure 24 is a top view of the manifold. [Figure 26] This figure shows an embodiment of a sensor assembly. [Figure 27] This graph shows the molar extinction coefficients of hemoglobin (Hb) and oxyhemoglobin (HbO2) in relation to the range of light wavelengths. [Figure 28] This is an electrical circuit diagram that includes a microcontroller for adjusting the gain of the sensor assembly. [Figure 29] This is a graph showing the light transmittance (UIN) and gain (UOUT) over time, with the gain adjusted based on the light transmittance relative to a predetermined threshold. [Figure 30]This is another graph showing the time-dependent light transmittance (UIN) and gain (UOUT), with the gain adjusted based on the light transmittance relative to a predetermined threshold. The gain adjustment can take hysteresis effects into account. [Figure 31] This is a diagram of a blood management system, including a medical waste collection system, a sponge system, and a user interface. [Modes for carrying out the invention]

[0021] Figures 1 and 2 illustrate a medical waste collection system 40 for collecting waste materials generated during medical procedures, more specifically during surgical procedures. Waste materials may include smoke, body tissue, and waste fluids such as body fluids and irrigation fluids. Often, medical procedures require large quantities of saline and / or other irrigation fluids for irrigation of anatomical sites. The medical waste collection system 40 collects and / or stores the waste materials until it becomes necessary or desired to empty and dispose of them. The medical waste collection system 40 can be transported to and operably coupled to a docking station for emptying the waste materials. The docking station may otherwise take any preferred form, such as that disclosed in U.S. Patent No. 7,621,898 issued November 24, 2009, which is jointly owned by the applicant and whose entire contents constitute part of this specification by reference.

[0022] The medical waste collection system 40 may include a chassis 42 and wheels 44 for moving the system 40 along the floor surface within a medical facility. The medical waste collection system 40 includes at least one waste container 46 that defines a waste volume section for collecting and storing waste materials. A vacuum source 48 may be supported on the chassis 42 and configured to provide suction to the waste container 46 through one or more internal lines 50. The vacuum source 48 may include a vacuum pump 52 and a vacuum regulator 54 (Schematicly shown in Figure 2) supported on the chassis 42 and in fluid communication with the waste container 46. The vacuum regulator 54 is configured to adjust the level of suction drawn by the vacuum pump 52 to the waste container 46. Preferred structures and operations of several subsystems of the medical waste collection system 40 are disclosed in U.S. Patent Application Publication No. 2005 / 0171495, published on 4 August 2005, International Publication No. 2007 / 070570, published on 21 June 2007, International Publication No. 2014 / 066337, published on 1 May 2014, and International Publication No. 2017 / 15284, published on 29 June 2017, all of which are jointly owned by the applicant and constitute part of this specification by reference. In other configurations, the vacuum source 48 may be a separate unit that can be detachably connected to the medical waste collection system 40 to suction the waste container 46. Preferred structures and operations of such configurations are disclosed in U.S. Patent No. 10,105,470, issued on 23 October 2018, all of which are jointly owned by the applicant and constitute part of this specification by reference.

[0023] The front of the chassis 42 may define a window 56 that allows a user to view the waste container 46. In embodiments in which the waste container 46 contains a transparent or translucent material, the user can view the level of waste material inside 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 help the user observe the level of waste material inside the waste container 46. Visualizing the contents of the waste container 46 can be particularly advantageous for a qualitative assessment of the degree of blood loss, especially when the waste material contains bodily fluids such as blood and non-blood fluids. A qualitative assessment can be added to the quantitative blood loss (QBL) analysis described. For example, the user can visually monitor the color of the waste material through the window 56, and if the color becomes very reddish, indicating excessive blood loss, the user can choose to view a control panel 58 displaying the quantitative blood loss analysis.

[0024] A control panel 58 located on the chassis 42 communicates with a controller 60 (Schematically shown in Figure 2), which includes a processor. The controller 60 is configured to generate a signal to the vacuum regulator 54 to operate the vacuum regulator 54 and adjust the vacuum level in the waste container 46. In another configuration, the controller 60 is configured to generate a signal to operate the vacuum source 48 to maintain or adjust the vacuum level in the waste container 46.

[0025] The medical waste collection system 40 includes at least one receiver 62 supported on a chassis 42. In its most comprehensive sense, the receiver 62 defines an opening 64 (see Figure 18) sized to removably receive at least a portion of a manifold 66, described later. Figure 2 shows a single receiver, but two receivers associated with one each of multiple waste containers are envisioned. A suction path can be established from the suction tube(s) through the manifold 66, which is removably inserted into the receiver 62, to the waste container 46. In other words, the vacuum generated by the vacuum source 48 is drawn through the suction tube(s), and waste material at the surgical site is drawn through the manifold 66, through the receiver 62, and into the waste container 46. The manifold 66 includes features described later, configured to facilitate QBL analysis of the fluid inflow. The manifold 66 can be a disposable component.

[0026] The fluid characterization module 68 is configured to facilitate the quantification of the blood concentration in the fluid drawn through the medical waste collection system 40 under the influence of suction. The quantification of the blood concentration in the fluid facilitates QBL analysis. The fluid characterization module 68 includes a sensor assembly 70 and may further include a module housing 72. In certain embodiments, the fluid characterization module 68 is integrated with or configured to be connected to the manifold 66, and in other embodiments, the fluid characterization module 68 is integrated with the medical waste collection system 40. Figure 2 schematically shows an embodiment in which the sensor assembly 70 of the fluid characterization module 68 is integrated with the medical waste collection system 40 by being connected to or positioned adjacent to an internal conduit 73 that communicates fluidly with the receiver 62. Other preferred locations for the fluid characterization module 68 are envisioned, e.g., adjacent to 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 in the fluid. In embodiments in which the fluid properties evaluation module 68 is integrated with the medical waste collection system 40, the conduit(s) 73 may be optically transparent, and may discolor or otherwise become soiled over time. A cleaning line may be provided, and the cleaning line is configured to guide water and / or detergent through the cleaning line and the conduit(s) 73 in order to maintain its optical properties. One preferred cleaning system is disclosed in U.S. Patent No. 7,612,898.

[0027] Referring here to Figures 3 to 6, embodiments of the manifold 66 are shown. The manifold 66 includes a housing 74 that defines the manifold volume 76. The manifold 66 may include a head 78 connected to a trunk 80, or in an alternative structure, the housing 74 of the manifold 66 may be a single unit or monolithic structure. The head 78 and the trunk 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 pipe (not shown). The trunk 80 may define an outlet opening 82 that is in fluid communication with the manifold volume 76 and the inlet fitting 88. A seal 84 may be connected to the housing 74 and sized to cover the outlet opening 82. A filter element 86 may be located within the manifold volume 76. In its broadest sense, the filter element 86 includes pores, openings, or other structures configured to capture or collect semi-solid or solid waste materials entrained in the fluid drawn through the manifold 66 under the influence of suction. It should be understood that not all manifold configurations require the use of a filter element, and the filter element can be located away from the manifold volume that communicates with the outlet opening 82 of the manifold 66.

[0028] In certain embodiments of the manifold 66, an outlet opening 82 is included, which is offset from the longitudinal axis of the manifold 66 and configured to function as a valve actuation unit for a rotatable valve of the medical waste collection system 40. More specifically, the trunk 80 may be substantially cylindrical so as to be inserted into the receiver 62 and then rotated to establish fluid communication between the manifold volume section 76 and the waste container 46, in the manner disclosed in U.S. Patent No. 7,615,037 issued on November 10, 2009, which is jointly owned by the applicants and whose entire contents form part of this specification by reference. In alternative embodiments of the manifold 66, the trunk 80 includes a feature section described below that allows the manifold 66 to be inserted proximal and the manifold to be removed distally from the receiver 62, in the manner disclosed in International Publication No. 2020 / 209898 published on October 15, 2020, which is jointly owned by the applicants and whose entire contents form part of this specification by reference. It should be understood that the feature components of the manifold 66, particularly the internal feature components related to facilitating QBL analysis, can be included in any embodiment of the trunk 80. In other words, the feature components described with reference to Figures 3 to 15 can be included in the trunk 80 shown in Figures 16 to 21, and the feature components described with reference to Figures 16 to 21 can be included in the trunk 80 shown in Figures 3 to 15.

[0029] The manifold 66 may include a projection 90. The projection 90 may function as a module connector so that the module housing 72 of the fluid characterization module 68 can be operably connected to the manifold 66. The projection 90 may be located on the head 78 and extend longitudinally from proximal to distal. The projection 90 may be elongated and have a width less than its length. The projection 90 may include a connector feature configured to engage with the module housing 72 of the fluid characterization module 68. For example, the connector feature may be a rail sized to be slidably positioned with a slot 92 defined by the module housing 72. Alternatively, the fluid characterization module 68 may be clipped to the projection 90 or otherwise secured. It should be understood that any preferred structure of the housing 74 or other components of the manifold 66 may be configured to be detachably connected to the fluid characterization module 68.

[0030] At least a portion of the housing 74 of the manifold 66 is optically transparent and defines a detection window 94. The detection window 94 is configured to be positioned adjacent to or between at least one emitter 96 and at least one sensor 98 of the sensor assembly 70. As will be further described, the emitter 96 and sensor 98 of the sensor assembly 70 are configured to detect the optical properties of a fluid passing through the suction path. In certain embodiments, the portion of the housing 74 defining the detection window 94 may be formed from a transparent material such as transparent plastic. The entire housing 74 may be formed from transparent plastic, and the portion of the housing 74 positioned between the emitter 96 and the sensor 98 constitutes the detection window 94. In certain embodiments, the housing 74 may be formed from a semi-opaque or opaque material having a notch sized to be fixedly bonded to an optically transparent panel. Embodiments in Figures 5 and 6 show a projection 90 defining the detection window 94. In such a configuration, at least a portion of the protrusion 90 can be made optically transparent so that, with the protrusion 90 positioned within the slot 92 of the fluid characteristics evaluation module 68, the sensor assembly 70 is positioned opposite the protrusion 90 so as to communicate optically with the detection window 94.

[0031] The fluid characterization module 68 in Figure 3 is shown as free-floating for illustrative purposes only. In one embodiment, the module housing 72 is connected to a dongle (not shown). The dongle may include data and power connections configured to be detachably connected to a complementary socket on the medical waste collection system 40. Once the data and power connections are established and the module housing 72 defines the slot 92, it may be slidably connected, for example, from the front of the manifold 66 along the projection 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 connected along the projection 90. It is understood that certain modifications to the housing 74 of the manifold 66 may be necessary to facilitate the detachable connection between the manifold 66 and the fluid characterization module 68 when the manifold 66 is inserted into the receiver 62 in the proximal direction.

[0032] As described above, the sensor assembly 70 includes emitters (may be more than one) 96 and sensors (may be more than one) 98. The emitters 96, 97 are configured to emit energy, and the sensors 98, 99 are configured to detect the emitted energy. An exemplary embodiment is a light energy-utilizing photosensor assembly having emitters 96, 97 which are light-emitting diodes (LEDs) and sensors 98, 99 which are photodetectors. The emitters 96, 97 and sensors 98, 99 are configured to be positioned opposite a detection window 94. Exemplary embodiments include two emitters and two sensors, and two emitters and four sensors, but it should be understood that any number or more of these can be provided. One of the emitters (also referred to herein as the first emitter 96) can be positioned facing the detection window 94 from two of the sensors, and another emitter (also referred to herein as the second emitter 97) is positioned facing the detection window 94 from the other two sensors. The four sensors detect the emitted light, more specifically, the light after it has been transmitted or scattered through the fluid passing through the detection window 94. The detected intensity of the transmitted or scattered light may indicate the transmittance, opacity, and / or other physical properties of the fluid. In an exemplary configuration, the first sensor 98 detects the transmitted light from the first emitter 96, the second sensor 99 detects the transmitted light from the second emitter 97, the third sensor (not shown) detects the scattered light from the first emitter 96, and the fourth sensor (not shown) detects the scattered light from the second emitter 97. The four measurements, namely two measurements of transmitted light and two measurements of scattered light, are values ​​provided to the processor to execute an algorithm for determining the concentration of blood in the fluid passing through the detection window 94.

[0033] An alternative configuration includes two sensors, namely a first sensor 98 and a second sensor 99, where the first emitter 96 is positioned opposite one of the detection windows 94 of sensor 98, and the second emitter 97 is positioned opposite the other detection window 94 of sensor 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. By positioning the emitters 96 and 97 opposite each other in the detection window 94, crosstalk between wavelengths of light emitted by the emitters 96 and 97 is limited or prevented. In another embodiment, the first emitter 96 and the second emitter 97 can be pulsed, i.e., each can be irradiated sequentially at a high frequency. The 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.

[0034] Embodiments including two sensors may be particularly suitable for space-constrained applications, as schematically shown in the configuration of Figure 26. The module housing 72 of the fluid characterization module 68 defines at least one passage through which the fluid or liquid is directed, identified as a detection window 94. The arrows in Figure 26 schematically indicate the light that is emitted and detected. Visible LEDs and infrared LEDs, for example, the first emitter 96 and the second emitter 97, emit visible light (G IN ) and infrared light (R IN The LEDs are configured to be positioned within the module housing 72 and directed toward the fluid being drawn in through the suction path (SP). The visible light LEDs and infrared LEDs can be placed within the openings of the module housing 72. As previously described, some of the visible light can be transmitted through the fluid (G T ), a portion of visible light can be scattered by fluids (G S Similarly, some infrared light can penetrate fluids (R T ), some infrared light can be scattered by fluids (R S)。The photodetectors, for example, the first sensor 98 and the second sensor 99, are 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 four values that are provided to an algorithm for determining the concentration of blood in the fluid. The photodetector can be disposed within the opening of the module housing 72. Two or four photodetectors can be provided. The fluid property evaluation module 68 of FIG. 26 is a non-limiting design, and in particular, the size and shape of the module housing 72 can be adapted to accommodate spatial constraints and / or the structure to which the module housing 72 is removably coupled. Similarly, the arrangement of the emitters 96, 97 and the sensors 98, 99 can be in any suitable manner for obtaining the necessary measurements of transmitted and scattered light.

[0035] 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 in the range of approximately 700 nanometers (nm) to 1000 nm, more specifically in the range of 750 nm to 850 nm, and even more specifically in the range of 770 nm to 810 nm. The visible light LED can be configured to emit light with wavelengths in the range of approximately 400 nm to 600 nm, more specifically in the range of 550 nm to 600 nm, and even more specifically in the range of 570 nm to 580 nm. The visible light LED can be a green LED. Figure 27 is a graph of the molar extinction coefficients of hemoglobin (Hb) and oxyhemoglobin (HbO2) over their respective wavelength ranges. Hemoglobin is the major protein in red blood cells, and oxyhemoglobin is the oxygen-carrying form of hemoglobin, which is bright red. The redness of blood, determined by oxyhemoglobin, affects the transmittance and scattering of light transmitted through the blood. Light transmittance can be a fluid property detected by the fluid property evaluation module 68. Green and infrared light have been shown to be optimal for determining the concentration of blood in a fluid. The measurement of infrared light absorbed by the fluid is determined by the reduction in transmitted light due to the presence of blood in the fluid. In one embodiment, the ratio of this absorbance of infrared light to scattered light from visible light is calculated and used to quantify the concentration of blood in the fluid.

[0036] It has been observed that the waste material drawn in through the manifold 66 may contain a mixture of gases and liquids, such as air and blood, respectively. The gas-liquid mixture may result from the gas and liquid being drawn into the suction tube connected to the inlet fitting 88, and / or from bubbles generated by collisions and turbulence within the internal geometry of the manifold 66. The presence of gas in the liquid can affect its optical properties and thus undesirably impair the accuracy of the transmitted and / or scattered light measurements. Referring further to Figures 4-6, the projection 90 can define a reservoir 100, which is configured to facilitate the separation of gases in the fluid from liquids in the fluid before the fluid characterization module 68 measures transmitted and scattered light. As best shown in Figures 5 and 6, the reservoir 100 can be positioned below the manifold volume 76. Conventionally, the liquid inlet 102 can define the boundary between the manifold volume section 76 and the liquid reservoir section 100, although the liquid reservoir section 100 can also be considered a lower volume section of the manifold volume section 76. Due to the relative size of the liquid inlet 102, the fluid can accumulate in the liquid reservoir section 100 and further accumulate in the manifold volume section 76. The accumulation of fluid in the liquid reservoir section 100 provides a short period during which gases can separate from liquids, for example, bubbles can separate from blood and other liquids (and possibly more) under the principles of bubble dynamics.

[0037] The manifold 66 may further include a fluid directionor 104 located within the housing 74. The fluid directionor 104 includes various geometric shapes configured to provide meandering paths for the fluid within the manifold 66. Among other advantages, the meandering paths can limit turbulence within the manifold 66, facilitate the separation of air from liquid in the fluid, and provide filtering of the fluid upstream of the sensor assembly 70. Continuing to refer to Figures 4–6, the fluid directionor 104 may be located within the manifold volume section 76 and at least partially within the head 78. The geometric shapes described can work in cooperation with the internal geometry of the housing 74 to define fluid flow paths (FFP) (i.e., including liquids and gases), liquid flow paths (LFP), and gas flow paths (GFP). Since gases have a lower density than liquids, gas flow paths can be located near the top surface of the manifold 66, while liquid flow paths can be located near the bottom surface of the manifold 66. In the illustrated embodiment, the liquid flow path is at least partially defined by a liquid reservoir 100 including a detection window 94.

[0038] The fluid directionor 104 includes a first barrier 106 and a second barrier 108, which can define a gas inlet 110, a gas channel 112, a liquid channel 114, and a fluid outlet 116. Furthermore, the second barrier 108 and the housing 74 of the manifold 66 can cooperate to define a liquid inlet 102 between the manifold volume section 76 and the liquid reservoir section 100. The first barrier 106 is configured to give a meandering path to the fluid entering the manifold 66 through the inlet fitting 88, and more specifically through the proximal end 118 of the inlet fitting 88. The meandering path, along with the size of the liquid inlet 102, can result in at least some accumulation of fluid within the manifold volume section 76. As described above, the accumulation provides a short period during which the gas can separate from the liquid. The separated gas occupies a portion of the manifold volume section 76 above the liquid and is drawn through the gas inlet 110 from the vacuum provided by the medical waste collection system 40. The separated gas is further drawn in through the gas channel 112 and the fluid outlet 116, and passes through the filter element 86 and the outlet opening 82. The separated liquid can be simultaneously drawn in through the liquid inlet 102 from the vacuum provided by the medical waste collection system 40. The separated liquid can be further drawn in through the liquid reservoir 100, which includes the detection window 94, the liquid channel 114, and the fluid outlet 116. The liquid that passes through the detection window 94 and is measured by the fluid characterization module 68 contains less gas, almost no gas, or no gas at all, and thus the accuracy of the measurements from the fluid characterization module 68 can be favorably maintained. For example, the relative absence of bubbles eliminates optical interference from the refractive properties of the bubble surfaces.

[0039] As best shown in Figures 5 and 6, the liquid and gas channels can be joined before the fluid outlet 116. In particular, 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 upstream of the confluence of the liquid and gas channels, there is no need to maintain their separation as the fluid is drawn through the rest of the manifold 66. Therefore, the detection window 94 can be positioned between the liquid inlet 102 and the liquid channel 114 and fluidically separated from the gas channel 112 (based on the direction of suction through the manifold 66).

[0040] To facilitate the meandering path and accumulation of fluid within the manifold volume 76, the first barrier 106 is positioned adjacent to the proximal end 118 of the inlet fitting 88 within the head 78. More specifically, the first barrier 106 can extend distally from the rear barrier 120 to the distal edge 122 positioned distal to the proximal end 118 of the inlet fitting 88. In other words, the first barrier 106 and the inlet fitting 88 can "overlap" in the elevation view of Figure 6. Furthermore, the liquid inlet 102 can be positioned distal to the proximal end 118 of the inlet fitting 88, and the first barrier 106 can be positioned adjacent to the gas inlet 110. In such a configuration, the first barrier 106 prevents a direct path from the proximal end 118 of the inlet fitting 88 to the gas inlet 110, effectively requiring the fluid passage to double back over itself at least once so that either the gas inlet 110 or the liquid inlet 102 can access the fluid inflow. The inlet fitting 88 can be laterally offset toward the wall of the housing 74 to achieve an overlapping position relative to the first barrier 106. The first barrier 106 (and / or the housing 74) can be contoured to promote less turbulence, which can further promote the separation of gas from liquid. The fluid passage can accumulate in the manifold volume section 76, with some of the accumulated liquid being drawn in from below through the liquid inlet 102, as previously described, and some of the gas separated from the liquid being drawn in from above through the liquid inlet 102, as previously described. The dimensions of the liquid inlet 102, taking into account the expected inflow velocity into the manifold volume section 76, can ensure a desired accumulation amount, for example, to provide a suitable opportunity for the gas to separate from the liquid.

[0041] If the fluid is mostly gas and contains little liquid, the manifold volume section 76 is efficiently emptied through the liquid reservoir section 100, as described above. If the fluid is mostly liquid, the accumulation of liquid in the manifold volume section 76 may reach the gas inlet 110. The gas inlet 110 can function as an overflow opening, after which both gas and liquid can be drawn in through the gas channel 112 and fluid outlet 116 of the fluid directional member 104. Any interruption or loss of suction is prevented by the continuous flow of liquid drawn in through the liquid flow path and measured in the detection window 94.

[0042] The relative geometry of the gas inlet 110, the manifold volume section 76, and the liquid channel 114 can be designed to minimize potential blockages and maximize inflow through the inlet fitting 88. For example, the outflow velocity of the liquid through the liquid channel can be based on the dimensions of the liquid channel 114, and perhaps more importantly, the dimensions of the reservoir section 100 defined by the projection 90. As described above, the detection window 94 can be part of the optically transparent projection 90, and in certain embodiments, the entire head 78 can be optically transparent. Due to the relatively high light absorption rate of blood, especially at higher concentrations, it is beneficial for the emitters 96, 97 and sensors 98, 99 positioned opposite the projection 90 to be sufficiently close in order to improve measurement accuracy. Therefore, in certain embodiments, the width of the projection 90, and thus the detection window 94, is less than three-quarters of an inch, more specifically about half an inch. The width of the protrusion 90 can affect the flow rate of the liquid through the detection window 94, and therefore can affect the outflow velocity of the liquid through the liquid channel. Furthermore, limiting the width of the protrusion 90 can correspondingly limit the required operating range of the emitters 96, 97 and sensors 98, 99, thereby improving accuracy using lower-cost electronic components. In addition to quantifying blood loss, embodiments using the fluid directionor 104 can also be used in conjunction with other applications of continuous flow measurement that can benefit from removing gas from a liquid, such as intravenous pumps and arthroscopy.

[0043] An alternative embodiment of the fluid directionor 104 is shown in Figure 7, in which a separate liquid channel defined by the fluid directionor 104 is not required. Rather, the first barrier 106 is positioned proximal to the proximal end 118 of the inlet fitting 88 to encounter the incoming fluid and direct it towards the manifold volume section 76 and the reservoir section 100 in a less turbulent manner. The accumulation of the incoming fluid in the reservoir section 100 allows the accumulated fluid to be agitated, thereby promoting the homogeneity of the fluid collected in the reservoir section 100, as measured by the fluid characterization module 68. The inlet 110 can initially provide a gas channel, but once sufficient fluid has accumulated in the reservoir section 100 and the manifold volume section 76, the inlet 110 functions as an overflow opening, after which both gas and liquid can be drawn in through the fluid outlet 116 of the fluid directionor 104.

[0044] Referring here to Figures 8 and 9, another embodiment of the manifold 66 is shown in which the fluid direction member 104 is positioned proximal to the filter element 86. In other words, the fluid direction member 104 is positioned closer to the outlet opening 82 than to the filter element 86. In such a configuration, the fluid entering the manifold volume 76 is filtered by the filter element 86 before encountering the detection window 94. As a result, any texture or semi-solid material that could affect the optical properties of the fluid is removed from the fluid. In other respects, the fluid direction member 104 may function similarly to the embodiments described above, using similar figures to identify similar components. In particular, Figure 9 shows a fluid direction member 104 including a liquid inlet 102, a gas inlet 110, and a fluid outlet 116. The fluid direction member 104 defines a gas channel 112 between the gas inlet 110 and the fluid outlet 116, and further defines a liquid channel 114 between the liquid inlet 102 and the fluid outlet 116.

[0045] In this embodiment, the fluid directionor 104 defines the detection window 94. More specifically, the liquid channel 114 can define the detection window 94, and therefore at least a portion of the fluid directionor 104 is optically transparent. In this embodiment, the fluid characterization module 68 is located within the manifold 66. Figure 9 generally shows the fluid characterization module 68 positioned within the trunk 80, with the liquid channel 114 positioned adjacent to or between the sensor assembly 70 of the fluid characterization module 68. In this embodiment, the fluid characterization module 68 may include a communication module (not specified) that wirelessly transmits a signal to the medical waste collection system 40, and a controller or processor 60 may require the use of the signal in real time to determine blood concentration and, as a result, perform QBL analysis. Alternatively, the fluid characterization module 68 may be positioned outside the manifold 66, and modifications to the trunk 80 are intended to allow optical communication with the fluid directionor 104 through the trunk 80, a portion of which may also be optically transparent. With the fluid properties evaluation module 68 engaged with the liquid channel 114 of the fluid directionor 104, this embodiment is understood to not include any protrusions defining the liquid reservoir, while still achieving proper separation of gas and liquid in the fluid before measuring the optical properties of the fluid.

[0046] Figures 10 and 11 show another embodiment of the manifold 66 in which the fluid is filtered by a filter element 86 before it encounters a detection window 94. The previous embodiment took into account positioning the filter element 86 distal to the detection window 94 and included a fluid characterization module 68 located within the trunk 80 of the manifold 66, whereas the fluid directioning member 104 of this embodiment redirects the fluid distally toward the reservoir 100. As a result, the fluid characterization module 68 can be connected to the outside of the head 78 of the manifold 66 (and optionally outside the receiver 62) despite the inflow of fluid that first passes through the filter element 86. The fluid directioning member 104 includes at least one redirection opening 124 that communicates with a transverse channel 126 extending longitudinally within the manifold 66. The fluid directioning member 104 further defines a reservoir 100 that communicates with the transverse channel 126 and further communicates with an outlet opening 82. Furthermore, the fluid direction member 104 can define a central channel 128 communicating with the reservoir 100 and a gas inlet 110 near the proximal end of the manifold 66. A ridge can separate the reservoir 100 from the lateral channel 126, and the ridge is sized to accommodate the fluid characterization module 68. The reservoir 100 is positioned between the sensor assemblies 70. To accommodate the lateral channel 126, the filter element 86 can be non-cylindrical and positioned in a stacked configuration with the fluid direction member 104. For example, the filter element 86 can be semi-cylindrical with a flat surface positioned to be supported on the upper surface of the fluid direction member 104.

[0047] Referring to Figure 9 and the arrows shown therein, the fluid enters the manifold 66 through the inlet fitting 88 and is then filtered by the filter element 86. Part of the fluid can enter the reservoir 100 through a hole at the base of the filter element 86, and part of the fluid enters the manifold volume section 76 through the proximal end of the filter element 86. The liquid in the fluid can be drawn towards the reservoir 100 through the central channel 128, while the gas is separated and drawn towards the outlet opening 82 through the gas inlet 110. Part of the fluid is drawn in through the reversal opening 124 and directed distally along the lateral channel 126. Near the distal end of the manifold 66, the fluid is again reversed from distal to proximal and enters the reservoir 100. The optical properties of the fluid passing through the reservoir 100 are measured by the sensor assembly 70 of the fluid properties evaluation module 68, and the fluid is then drawn toward the outlet opening 82.

[0048] In certain embodiments, a second filter element 130 can be provided. Referring here to Figures 12 to 15, the projection 90 of the manifold 66 can be molded and sized to accommodate the second filter element 130. The illustrated embodiment shows a cylindrical projection 90 extending downward from the head 78 of the manifold 66. The size and shape of the projection 90 allow the reservoir 100 of this embodiment to accommodate a larger volume of fluid, for example, to allow sufficient separation of gas and liquid in the fluid. The fluid characterization module 68 is positioned proximal to the reservoir 100, and therefore the size of the projection 90 can not be constrained by the technical limitations of the sensor assembly 70.

[0049] A second filter element 130 is located within the reservoir 100. In the first modified example shown in Figures 13 and 14, the second filter element 130 includes a spacer 132 that abuts against the base 134 of the projection 90 and is configured to create a gap between the second filter element 130 and the base 134. A straw 136 is located at least partially within the reservoir 100. The straw 136 includes a first end 138 located within the reservoir 100 and a second end 140 located within the manifold volume 76 (the dashed line defines the boundary between the reservoir 100 and the manifold volume 76). The fluid directionator 104 includes a first barrier 106 defining the gas inlet 110. The first barrier 106 requires that the inflow of fluid through the inlet fitting 88 be directed into the reservoir 100 under the influence of gravity. Within the liquid reservoir 100, the gas and liquid in the fluid can be separated by the method described above. The gas in the manifold volume section 76 is drawn through the gas inlet 110 toward the outlet opening 82. The liquid is accumulated in the liquid reservoir 100.

[0050] The remaining vacuum provided by system 40 is drawn through the straw 136. In other words, the vacuum on the second end 140 of the straw 136 draws the liquid from the reservoir 100 through the first end 138 of the straw 136 against gravity. The liquid is drawn through the straw 136 and further through the detection window 94 defined by the second projection 91. By convention, the second projection 91 can be elongated and configured to be positioned within a slot 92 of the module housing 72, thereby resembling a particular embodiment of the (first) projection 90 described above. As best shown in Figure 13, the second projection 91 can define a channel 142 that fluidly communicates with the reservoir 100 through the straw 136. The optical properties of the liquid passing through the detection window 94 are measured by the fluid properties evaluation module 68.

[0051] In another modification, the straw 136 may extend through a second filter element 130. Referring to Figure 15, the projection 90 may be tapered and / or define a stepped portion 144, and the second filter element 130 is supported on the stepped portion 144 so as to provide a gap above the base 134 of the projection 90. The base of the second filter element 130 defines an opening, and the straw 136 includes a stepped portion 146 supported within the opening. With the tapered portion of the projection 90 to the base 134 and the first end 138 of the straw 136 located in the center within the liquid reservoir 100, improved performance can be achieved with the straw 136. The liquid is drawn through the straw 136 and through the detection window 94 of the second projection 91.

[0052] Referring here to Figures 16 and 17, another embodiment of the manifold 66 is shown in which a fluid properties evaluation module 68 can be removably inserted into a portion of the housing 74 of the manifold 66. First describing the features of the trunk 80 configured to engage with the complementary features of the receiver 62 of the medical waste collection system 40, the manifold 66 includes an arm 148, a locking element 150, a spine 152, and / or a catch 154. For convention, directional references (e.g., proximal, distal, up, down, upward, downward, etc.) are made relative to the manifold 66 in the orientation shown in Figure 16 in which the manifold 66 is inserted into the receiver 62. The housing 74 may include a body 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 main body 156, and more specifically, one or both of the first leg 158 and the second leg 160 may extend proximal to the main body 156. The first leg 158 may be positioned below the second leg 160 when the manifold 66 is oriented to be inserted into the receiver 62. The first leg 158 and the second leg 160 may be spaced apart from each other by a gap 162, as best shown in the rear perspective view of Figure 21. It is understood that potentially minor modifications may be made to the illustrated geometry without departing from the above conventions. The housing 74 may include a rim 164 defining an outlet opening 82. The rim 164 may be located on the first leg 158, more specifically, at or near the proximal end of the first leg 158. In one convention, the rim 164 can be considered as a proximal-oriented surface at the proximal end of the first leg 158. The rim 164 may include a width greater than its height, such that the exit opening 82 is non-circular. The rim 164 may be configured to connect with the seal 84.

[0053] The manifold 66 includes arms 148 extending outward from the housing 74. While a pair of arms 148 are referred to, it is understood that a single arm may be provided. Figures 16 and 21 show arms 148 that are elongated rib-like structures in the proximal-distal direction and have a width greater than their thickness. Arms 148 can be sized and molded to be movably inserted into arm slots that define the opening 64 of the receiver 62 (see Figure 18). It should be understood that not all configurations of the manifold 66 require the use of arms 148, and manifold designs without arms are intended. Each arm 148 includes a proximal-oriented surface 166 configured to engage with the receiver 62 during insertion of the manifold 66 into the receiver 62, facilitating the movement of the receiver 62 and its components between certain operating positions. The proximal-oriented surface 166 of the arm 148 can be positioned distal to the rim 164.

[0054] The manifold 66 includes a pair of catches 154, which are described later. It should be understood that a single catch may be provided, and a manifold design without any catches (or more) is intended. The catches 154 may be positioned on the second leg 160. Each of the catches 154 includes a distally oriented surface 168 configured to engage with the claws of the receiver 62 while inserting the manifold 66 into and removing it from the receiver 62, in order to facilitate the movement of the receiver 62. The distally oriented surface 168 of the catch 154 may be positioned proximal to the rim 164 and proximal to the proximal oriented surface 166 of the arm 148. The rim 164 and at least one of the catches 154 can be separated from each other by a gap 162. More specifically, the rim 164 on the first leg 158 can be separated from the catch 154 on the second leg 160 by a gap 162. In other words, the rim 164 may be located on the first side or below the gap 162, and the catch 154 may be located on the second side or above the gap 162, opposite to the first side or below. Furthermore, the rim 164 is positioned below the catch 154 when the manifold 66 is oriented to be inserted into the receiver 62.

[0055] The manifold 66 may include a spine 152 extending outward from the housing 74. The spine 152 is an elongated structure in the proximal-distal direction and may include a width greater than its thickness. The spine 152 may extend outward from at least one of the main body 156 and / or the first leg 158. Furthermore, the spine 152 may extend downward from the bottom wall of the trunk 80. The spine 152 includes a proximal-oriented surface 170 configured to engage with the threadlock assembly of the receiver 62 while inserting the manifold 66 into and removing it from the receiver 62, and to facilitate the movement of the receiver 62 and its components between operating positions. The proximal-oriented surface 170 of the spine 152 may be positioned distal to the rim 164, distal to the distal-oriented surface 168 of the catch 154, and distal to the proximal-oriented surface 166 of the arm 148. In a particular embodiment, the proximal-oriented surface 170 is inclined proximal toward the housing 74 so as to define the proximal end of the spine 152. The inclination can be an inclined surface.

[0056] The manifold 66 includes locking elements 150 extending outward from the housing 74. While a pair of locking elements 150 are referred to throughout this disclosure, it is understood that a single locking element may be provided, and that manifold designs without locking elements are intended. Figure 16 shows each of the locking elements 150 such that they share an elongated structure as one of each of the arms 148. In particular, each locking element 150 may include a distally oriented surface at the distal end of an elongated structure opposite to a proximal oriented surface 166 of the arm 148. The locking elements 150 may extend outward from at least one of the body portion 156 and the first leg portion 158. The distally oriented surface is configured to engage with the locking assembly of the receiver 62 after the manifold 66 has been inserted into the receiver 62, in order to selectively prevent distal movement of the manifold 66 relative to the receiver 62. The distally oriented surface of the locking element 150 can be positioned distally to the rim 164, distally to the distally oriented surface 168 of the catch 154, distally to the proximally oriented surface 166 of the arm 148, and distally to the proximally oriented surface 170 of the spine 152. The relative proximal-to-distal positions of the rim 164, the proximally oriented surface 166 of the arm 148, the distally oriented surface 168 of the catch 154, the proximally oriented surface 170 of the spine 152, and / or the distally oriented surface of the locking element 150 are adjusted to facilitate the precise timing of the complementary components of the receiver 62 when the manifold 66 is inserted into the receiver 62.

[0057] The head 78 is positioned distal to the trunk 80 when the manifold 66 is oriented to be inserted into the opening 64 of the receiver 62. The head 78 may include a first inlet fitting 88a and a second inlet fitting 88b. More specifically, the head 78 may define an accessory sleeve 172 extending from the accessory opening 174, and the first inlet fitting 88a may extend upward from the upper barrier 176 of the accessory sleeve 172. The second inlet fitting 88b extends distally from the cap faceplate 178 and defines a second inlet bore (also referred to as a bypass bore). The accessory sleeve 172 is in fluid communication with the manifold volume section 76, which is mainly defined by the trunk 80.

[0058] The fluid characterization module 68 is configured to be removable through an accessory opening 174 and supported within an accessory sleeve 172. A tray 180 may be provided to facilitate the removable positioning of the fluid characterization module 68 within the accessory sleeve 172. In its most comprehensive sense, the tray 180 provides a module coupling portion to which the module housing 72 of the fluid characterization module 68 is coupled. With the tray 180 positioned within the accessory sleeve 172, the fluid characterization module 68 is in optical communication with the suction path, particularly the inflow of fluid through the first inlet fitting 88a. The tray 180 includes a side surface 182 and a base portion 184 coupled to the side surface 182 and collectively defining a cavity. The fluid characterization module 68 can be coupled to the base portion 184 and / or positioned within the cavity. More specifically, the fluid properties evaluation module 68 may include a printed circuit board (PCB) assembly 186 that is sized and molded to fit the opening of a cavity defined by the module housing 72.

[0059] The tray 180 may also include a sealing member 188 adapted to engage with the accessory opening 174 when the tray 180 is inside the accessory sleeve 172, in order to facilitate the maintenance of the suction path through the manifold 66. The sealing member 188 includes an elastic flexible portion 190 between upper and lower regions 192. Input to the control member 194 causes the flexible portion 190 to move elastically and pivotably away from the accessory opening 174, as described in International Publication No. 2019 / 0222655, published on November 21, 2019, which is jointly owned by the applicant and whose entire contents form part of this specification by reference, thereby providing “bleeding” of the suction path.

[0060] The fluid characterization module 68 includes a sensor assembly 70 configured to be removably inserted through an accessory opening 174 and positioned within an accessory sleeve 172. The sensor assembly 70 includes emitters 96, 97 configured to release energy and sensors 98, 99 configured to detect the released energy. The emitters 96, 97 and sensors 98, 99 are positioned opposite the suction path. For example, the fluid characterization module 68 includes a recess, opening, or other type of void to which the suction path is directed. For example, as best shown in Figure 16, the detection window 94 may consist of a transparent tube or another component of the tray 180 positioned within the accessory sleeve 172. At least one of the emitters 96, 97 is positioned on one side of the detection window 94, and at least one of the sensors 98, 99 is positioned on the other side of the detection window 94. As best shown in Figure 17, the emitters 96, 97 can be connected and positioned on both sides of the PCB assembly 186. In one example, the first emitter 96 is positioned opposite one of the recesses and sensors 98 of the PCB assembly 186, and the second emitter 97 is positioned opposite the other of the recesses and 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, namely two measurements of transmitted light and two measurements of scattered light, are values ​​provided to the controller or processor 60 to execute an algorithm for determining the blood concentration of the fluid. It is understood that the above alternative configuration, in which two (or three) emitters and four sensors are provided, can be included in embodiments of the fluid characterization module 68 disposed on the tray 180.

[0061] As can be understood from the use of visible and infrared light, sensors 98 and 99 can have high sensitivity in both the visible and infrared regions of the electromagnetic spectrum. One suitable sensor is the OSRAM SFH3310 phototransistor, which is not only optimized for detecting visible light but also maintains approximately 35% of its maximum sensitivity in the infrared region. It should be noted that the magnitude of the infrared light emitted by the second emitter 97 is relatively larger than that of scattered green light, and therefore, the decrease in sensitivity of sensors 98 and 99 in the infrared region of the electromagnetic spectrum should not impair the performance of sensors 98 and 99.

[0062] The fluid characteristics evaluation module 68 may further include at least one integrated circuit. In one embodiment, the fluid characteristics evaluation module 68 includes an LED driver integrated circuit 196, a photosensor integrated circuit 198, and a microcontroller 200 that communicates with the LED driver integrated circuit 196 and the photosensor integrated circuit 198. The LED driver integrated circuit 196 is configured to supply current to drive a first emitter 96 and a second emitter 97. The photosensor integrated circuit 198 is configured to transmit signals generated by sensors 98, 99 to the microcontroller 200 (or to controller 60 or another processor). The microcontroller 200 is configured to convert the signals into the aforementioned values ​​provided to an algorithm to determine the blood concentration of the fluid.

[0063] The fluid properties evaluation module 68 may include a communication module 202 (see Figure 23), such as a transceiver. The communication module 202 may be a component of the microcontroller 200. In one example, the communication module 202 utilizes the Bluetooth Low Energy Protocol to wirelessly transmit data. The data can be transmitted to a medical waste collection system 40, a mobile device with appropriate software, or any other suitable electronic device for evaluating patient blood loss.

[0064] The fluid characteristics evaluation module 68 may further 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 be configured to communicate with the battery management integrated circuit 206 and to receive power from the battery 204 as regulated by the battery management integrated circuit 206. In one embodiment, the battery 204 may be rechargeable. For example, the battery 204 may be recharged on a charging station or on a charging port integrated with a medical waste collection system 40. The battery management integrated circuit 206 is configured to manage the charging and power level monitoring of the battery 204. For example, when the battery 204 is low, the battery management integrated circuit 206 may be configured to send an alert that is displayed on a control panel 58 or another electronic device.

[0065] Referring here to Figure 18, another embodiment of the fluid characterization module 68 is shown, configured such that the module housing 72 is removably connected to the head 78 of the manifold 66. The manifold 66 includes a plurality of inlet fittings 88a, 88b, 88c, and 88d. Four inlet fittings are shown, but more or fewer are intended. At least one of the inlet fittings 88a, 88b, 88c, and 88d can 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, and 88d for connecting 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 in the module housing 72. Suction tubes(s) can be connected to the distal first inlet fittings 88a and second inlet fittings 88b of the module housing 72, such that the module housing 72 is positioned between the suction tubes(s). With the manifold 66 removably positioned within the receiver 62, a suction path is established from the suction tubes(s)(s) through the first inlet fittings 88a and second inlet fittings 88b and the manifold volume section to the receiver 62 and the waste container 46 of the medical waste collection system 40. Thus, the fluid characterization module 68 is in optical communication with the suction path via the optically transparent first inlet fittings 88a and second inlet fittings 88b. The fluid characterization module 68 can be electronically connected to the medical waste collection system 40 using a dongle (not shown).

[0066] In a particular embodiment, the manifold 66 is disposable after each use and provides a sterile barrier between the fluid and the medical waste collection system 40. Similarly, the detection window 94 of the manifold 66 provides a sterile and liquid barrier between the fluid and the electronic components of the fluid characterization module 68. In such a configuration, the fluid characterization module 68 can be a main component configured to be reused, while the manifold 66 can be a disposable component configured to be discarded after use. Therefore, it may be desirable to integrate the fluid characterization module 68 into or as a component of the medical waste collection system 40. Referring here to Figures 19 to 22, the fluid characterization module 68 can be integrated with the receiver 62. In particular, the fluid characterization module 68 can be located in the inlet mechanism 208 of the receiver 62. The inlet mechanism 208 includes a suction fitting 210 configured to define a suction inlet and to penetrate a seal 84 and be at least partially positioned within the first leg 158 of the manifold 66, as best shown in Figure 20. With the suction fitting 210 passing through the seal 84, a sealed fluid communication is provided between the manifold volume section 76 and the receiver 62.

[0067] 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 the fully inserted operating position. The first support element 212 and the second support element 214 may have an arched shape and be contoured to match the first leg portion 158. Furthermore, the first support element 212 and the second support element 214 may be spaced apart from the suction fitting 210 by a distance equal to at least the thickness of the first leg portion 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. With the manifold 66 inserted into the receiver 62 and in the fully inserted position, the first support element 212 is seated or housed within the gap 162 with the seal 84 engaged with the suction fitting 210. The first support element 212 can further support the manifold 66 to minimize its movement relative to the receiver 62 when it is in the fully inserted position.

[0068] The inlet mechanism 208 is movable within the receiver 62 and prevents fluid communication between the vacuum source 48 and the manifold 66 unless the manifold 66 is in the fully inserted position. In particular, the inlet mechanism 208 can be made movable in the proximal-distal direction. As the manifold 66 is moved proximal towards the fully inserted position, the inlet mechanism 208 is translated distally, and as the manifold 66 is moved distally away from the fully inserted position, for example, while removing the manifold 66, the inlet mechanism 208 is translated proximal and disengages from the alignment with the receiver outlet. Finally, when the manifold 66 is in the fully inserted position, the suction outlet and the receiver outlet are aligned to provide fluid communication between the manifold 66 and the waste container 46 (see Figure 20).

[0069] In this embodiment, the inlet mechanism 208 is positioned particularly well for integration with the fluid characteristics evaluation module 68 because it defines a portion of the suction path. Figure 22 shows emitters 96, 97 and sensors 98, 99 connected to the inlet mechanism 208. Specifically, the first emitter 96 is connected to the first support element 212, the second emitter 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 can further accommodate an LED driver integrated circuit 196, a photosensor integrated circuit 198, and a microcontroller 200. In this embodiment, the fluid characteristics evaluation module 68 and its electronic components can be powered by the power supply of the medical waste collection system 40, and therefore a battery may not be provided.

[0070] The suction fitting 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 emitter 96 and a first sensor 98 on a first support element 212 and a second emitter 97 and a second sensor 99 on a second support element 214. The first window 218 and the second window 220 of the inlet mechanism 208 are configured to further align with the first window 222 and the second window 224 of the manifold 66 when the manifold 66 is in the fully inserted operating position. In other words, the manifold 66 may include a detection window 94, which itself is formed from the first window 222 and the second window 224. The first window 222 and the second window 224 may be optically transparent. Referring here to Figure 21, the first leg 158 of the trunk 80 can define a first window 222 on its upper surface 226 and a second window 224 on its lower surface 228. With the first window 222 and the second window 224 on the first leg 158, the catch 154 and the first window 222 are separated by a gap 162. The first window 222 and the second window 224 are positioned below the second leg 160 when the manifold 66 is oriented to be inserted into the receiver 62. Furthermore, the first window 222 and the second window 224 can be positioned distal to the rim 164, distal to the proximal-oriented surface 166 of the arm 148, distal to the proximal-oriented surface 170 of the spine 152, distal to the distal-oriented surface 168 of the catch 154, and proximal to the distal-oriented surface of the locking element 150.

[0071] With the manifold 66 in the fully inserted position, optical communication is provided between the emitters 96, 97 and the sensors 98, 99. In particular, light emitted from the first emitter 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 emitter 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, the fluid flows through the first leg 158 toward the seal 84 and through the seal 84. Thus, the transmitted and scattered light can be detected using the first sensor 98 and the second sensor 99, and four values ​​are provided to the algorithm. Furthermore, this configuration results in the fluid contacting only the manifold 66 and not the fluid characterization module 68, thereby limiting contamination of the inlet mechanism 208 inside the medical waste collection system 40 and / or the need for inspection or cleaning.

[0072] In certain embodiments, a radio frequency identification (RFID) tag 216 can be connected to the manifold 66 and positioned to be detected by a sensor (e.g., a data reader) of the medical waste collection system 40. Referring to Figures 3-6, 16, 18, and 21, it should be understood that the RFID tag 216 can be positioned on the upper wall or top surface of the trunk 80, and the remaining illustrations of the manifold 66 can also include the RFID tag 216. More specifically, the RFID tag 216 can be positioned at least partially on the main body 156 and / or at least partially on the second leg 160. The RFID tag 216 can be configured to be detected by the 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. For the reasons stated above, if the item cannot be inserted into the fourth operating position or the full insertion operating position, data communication will not be established between the RFID tag 216 and the reader, and the controller 60 may prevent the operation of the medical waste collection system 40. In certain embodiments, the RFID tag 216 may include a memory that stores data for determining whether the manifold 66 is usable 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 the resulting action. 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 certain embodiments, the memory of the RFID tag 216 may store calibration data for emitters 96, 97 and / or sensors 98, 99. If authentication is successful, the calibration data is provided to the processor 60 for accurate quantification of the concentration of blood in the fluid.

[0073] As mentioned above, quantifying the blood concentration in a fluid from a patient can then facilitate the quantification of the patient's blood loss or QBL analysis, which is a particularly important metric for healthcare professionals. To quantify the volume of blood loss, it is necessary to determine the amount of fluid collected. 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 volume of blood loss. One exemplary method by which the volume of collected fluid can be determined is by measuring the volume of fluid in a waste container 46 of a medical waste collection system 40. A fluid measurement assembly 47 can be provided, in which a float element configured to float on the fluid moves along a sensor rod. An interrogating signal is sent along the sensor rod, and a return signal is detected based on the position of the float element along the sensor rod. One preferred fluid measurement assembly 47 is disclosed in U.S. Patent No. 7,612,898 mentioned above. The fluid measurement assembly 47 can communicate with a processor 60 and / or wirelessly communicate 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 period of time. A flow sensor (not shown) can be placed at any suitable location in the suction path. The flow sensor can communicate with the processor 60 and / or wirelessly with another device. The flow sensor can be an ultrasonic sensor. Embodiments utilizing the flow sensor can provide real-time quantification and display of blood loss on the control panel 58 or another electronic device.

[0074] Referring here to Figure 23, the main routine 300 is shown as a schematic diagram of the workflow for real-time quantification of blood loss, including an optical acquisition subroutine 302, a volume acquisition subroutine 304, and a blood volume calculation subroutine 306. The main routine 300 initiates step 308. Step 308 may include the user initiating the operation of the medical waste collection system 40 with the manifold 66 detachably inserted into the receiver 62. Step 308 may further include the data reader of the medical waste collection system 40 detecting an RFID tag 216 placed on the manifold 66, and the data transmitted to the data reader reflecting that the manifold 66 includes a fluid characterization module 68. In other words, the medical waste collection system 40 identifies the manifold 66 as the type to be used to determine blood loss (other manifolds may not have such capability), and therefore needs to initiate the main routine 300. Alternatively, step 308 may include the user selecting on the control panel 58 that QBL analysis is desired.

[0075] In steps 310a and 310b, the emitters 96, 97 and / or sensors 98, 99 can be calibrated and the optical readings normalized. The power output from the emitters 96, 97, the sensitivity of the sensors 98, 99, and the optical clarity of the detection window 94 may vary over time. For example, these variations may be caused by aging, temperature changes, contamination, component tolerances, etc. Steps 310a and 310b can be performed at startup and / or during a “downtime” when the medical waste collection system 40 is idle. In one embodiment, steps 310a and 310b include calibrating the infrared LED and the visible light LED, respectively. The LEDs are switched off, and after a few seconds for thermal equalization, the output from the sensors 98, 99 is stored as the “dark” calibration reading d. The LEDs are switched, and after a few seconds for heat equalization, the outputs from sensors 98 and 99 are stored as the "bright" calibration reading b. These values ​​are stored in the memory of the calibration data database 312. During system operation, any sensor value reading s is converted to an absorbance value A using the following formula.

number

[0076] By performing steps 310a and 310b, all subsequent readings for the light and dark calibration values ​​are rendered. Furthermore, by converting to absorbance, the optical readings are transformed from a fundamentally logarithmic region to a linear region that is easier to model. The resulting calibration data can be provided to the calibration data database 312.

[0077] Alternatively, calibration data may be provided by a calibration data database 312 that has been pre-stored. The calibration data database 312 can store calibration data for one or more emitter models and one or more photodetector models. The emitter and sensor models on the specific fluid characterization module 68 may be data transmitted from the RFID tag 216 to the data reader. Calibration data can be written to the calibration data database 312. Steps 310a and 310b are optional.

[0078] In step 314, an optical signal delay can be set. Additionally or alternatively, in step 314, a volume signal delay can be set. Because there is a physical distance between the sensor assembly 70 and the fluid measurement assembly 47, there is a delay between when the sensor assembly 70 measures the properties of the fluid and when that same fluid enters the waste container 46 and is measured by volume change using the fluid measurement assembly 47. Furthermore, since the blood concentration and the collected fluid volume are used together to calculate the volume of blood loss, the two signals can be synchronized. In one embodiment, the optical signal is delayed before being multiplied by the volume signal. The resulting delay data can be provided to the delay database 316. Step 314 may be optional. In another embodiment, the delay is updated based on the calculated blood concentration. In such an embodiment, step 314 may be considered an initial delay, but thereafter the delay is continuously adjusted based on the calculated percentage of blood. This can favorably improve accuracy by taking into account a higher percentage of blood that moves more slowly through the system, and therefore requires a longer delay value.

[0079] After step 310, the optical acquisition subroutine 302, the volume 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. Continuing to refer to Figure 23, the optical acquisition subroutine 302 includes step 320, which waits for an interrupt. The main routine 300 may remain idle until it receives notification (an interrupt) from the optical acquisition subroutine 302 and the volume acquisition subroutine 304 that additional data has been generated. The main routine 300 uses the data to determine the blood volume for a given period. The main routine 300 then remains idle until the next interrupt. The optical acquisition subroutine 302 may further include step 322, which generates an optical signal. The optical signal is generated by emitters 96, 97 that emit light energy, such as visible light and infrared light. The optical acquisition subroutine 302 includes step 324, which acquires the optical signal. Optical signals are acquired by sensors 98 and 99, in particular, transmitted and scattered light are acquired for visible light and infrared light, respectively. Step 324 may include accumulating the optical signal data and transmitting the optical signal data to the optical signal database 326. The optical acquisition subroutine 302 includes an optional step 328 for controlling emitters 96 and 97, and / or an optional step 330 for gain adjustment, which will be described in more detail. Step 328 includes monitoring the current flowing through emitters 96 and 97. If the current increases or decreases (for example, due to some external influence such as a change in temperature), the control signal to the LED driver integrated circuit 196 is adjusted to compensate. The optical acquisition subroutine 302 can be run at a sampling rate in the range of approximately 800 samples / second (sam / sec) to 1000 sam / sec, more specifically in the range of approximately 875 sam / sec to 925 sam / sec, and even more specifically, approximately 900 sam / sec. Optical signal conversion can be performed 10,000 times per second, and the filtered results can be stored 900 times per second.

[0080] The volume acquisition subroutine 304 includes the steps of generating a volume signal for measuring the volume of fluid in the waste container 46 (step 332) and acquiring the signal (step 334). As previously described, the fluid measurement assembly 47 can determine the volume of collected fluid in the waste container 46, and / or the flow sensor can measure the flow rate of fluid in the suction path to determine the volume of collected fluid. The determined volume is provided as volume data, and step 334 may include accumulating the volume data and transmitting it to the volume data database 336. The volume acquisition subroutine 304 can 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, approximately 1000 calc / sec.

[0081] The blood volume calculation subroutine 306 includes step 338, which receives the accumulated optical signal data from the optical signal database 326 and calculates the average optical signal. The average optical signal can be provided to the optical output (O / P) database 340. The optical output is the average optical data from sensors 98, 99 over the last period (e.g., 1 / 10 second). Step 346 is similar except for the volume data. Then, in step 350, the volume data is used to calculate the flow rate, in particular the difference between the most recent volume measurement and the previous volume measurement. The flow rate data can be provided to the flow rate O / P database 352. The delayed optical data is determined in step 354, and the data is converted to a percentage concentration of blood. This can indicate the blood concentration in the fluid over the last period (e.g., 1 / 10 second). The flow rate is obtained in step 356 and multiplied by the blood concentration to determine the volume of blood loss. The blood volume calculation subroutine 306 can be executed at a calculation speed of approximately 5 calculations / second (calc / sec) to 15 calc / sec, more specifically within the range of approximately 8 calc / sec to 12 calc / sec, and even more specifically, approximately 10 calc / sec.

[0082] As described above, there may be a delay between the time the sensor assembly 70 measures the optical properties of the fluid and the time the same fluid enters the waste container 46 and is measured using the fluid measurement assembly 47. Referring now to Figures 24 and 25, another embodiment of the manifold 66 is shown in which the volume of the fluid can be determined immediately before the optical properties of the fluid are detected using the fluid properties evaluation module 68. The manifold 66 includes at least one barrier 230 that divides the manifold 66 into at least a first reservoir 232 and a second reservoir 234. The first reservoir 232 and the second reservoir 234 are not in fluid communication with each other. The inlet fitting 88 selectively communicates with one of the first reservoir 232 and the second reservoir 234 in a manner described later. The 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 in fluid communication with the first reservoir 232 and the second reservoir 234, respectively. Each of the first outlet fitting 236 and the second outlet fitting 238 is configured to receive an outlet suction pipe so that the manifold 66 operates in an in-line configuration. The outlet suction pipe is connected to a fluid characterization module 68. An adapter may be provided to merge the outlet suction pipe before the fluid flow encounters the fluid characterization module 68.

[0083] The manifold 66 includes a first fluid level assembly 240 and a second fluid level assembly 242, associated with the first reservoir 232 and the second reservoir 234, respectively. Figure 25 shows the first fluid level assembly 240 located in the first reservoir 232 and the second fluid level assembly 242 located in the second reservoir 234. The first fluid level assembly 240 and the second fluid level assembly 242 are configured to function as mechanically actuated valves to provide selective fluid communication between the inlet fitting 88 and one of the first reservoir 232 and the second reservoir 234, and further to provide selective communication between one of the first reservoir 232 and the second reservoir 234 and their respective outlet fittings 236, 238. The first fluid level assembly 240 and the second fluid level assembly 242 include a float element connected to a mechanism that pivots a distal flow directional member 244 and a proximal flow directional member 246 connected to the distal flow directional member 244. It is intended that electronic sensors may be provided instead to determine the respective fluid levels, and / or electronically operated valves may be provided instead to selectively alternate the suction paths.

[0084] The first fluid level assembly 240 and the second fluid level assembly 242 are adjusted to alternately switch the suction path between the first reservoir 232 and the second reservoir 234 at a predetermined or determinable fluid level. Because the dimensions of the manifold 66 are fixed, the suction path is effectively alternately switched between the first reservoir 232 and the second reservoir 234 with a known fluid volume. Thus, when the suction path is alternately switched, a known volume of fluid is drawn through the fluid characterization module 68, thereby eliminating the aforementioned delay between optical measurement and volume measurement.

[0085] For example, Figure 25 shows a manifold 66 in a first configuration in which the distal flow directioning member 244 is positioned or angled so that the second barrier 248 directs the fluid into the second reservoir 234. The proximal flow directioning member 246 is correspondingly positioned or angled so as to block the second outlet opening and allow flow through the first outlet opening. When a vacuum is drawn to both outlet suction pipes, there is no vacuum in the second reservoir 234, but there is a vacuum at the inlet fitting 88 through the first reservoir 232. The inflow of fluid collects in the second reservoir 234, and the float element of the second fluid level assembly 242 rises accordingly. Due to the interconnection of the mechanism, when the collected fluid and float in the second reservoir 234 reach a predetermined level, the distal flow directioning member 244 and the proximal flow directioning member 246 are shifted to alternately switched positions. In other words, the manifold 66 is moved to a second configuration in which the distal flow directionor 244 is positioned or angled to direct the fluid into the first reservoir 232, and the proximal flow directionor 246 is positioned or angled to allow flow through the second outlet opening. In the second configuration, the vacuum begins to empty the second reservoir 234 through 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 reservoir 234 to the waste container 46. Perhaps simultaneously, additional waste fluid is accumulating in the first reservoir 232. The manifold 66 can be selectively switched between the first and second configurations or toggled to repeat the process a desired or required number of times.

[0086] As explained earlier, the optical acquisition subroutine 302 includes a gain adjustment step 330. Gain adjustment is necessary because blood is very effective at absorbing and scattering light, and therefore, as the blood concentration increases, the amount of light passing through the blood decreases very rapidly, which in some cases can result in insufficient sensitivity and resolution of sensors 98, 99 at high concentrations. For example, if a high gain is selected for sensors 98, 99, sensors 98, 99 may saturate when the blood concentration level is low, which can result in insufficient 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 the blood concentration increases, the gain of sensors 98, 99 can be increased. More specifically, when the light detected by sensors 98, 99 falls below a predetermined transmittance threshold, the gain of sensors 98, 99 increases. Conversely, as the blood concentration decreases, the gain of sensors 98, 99 can be decreased. More specifically, when the light detected by sensors 98 and 99 rises above a predetermined transmittance threshold (or another predetermined transmittance threshold), the gain of sensors 98 and 99 decreases.

[0087] In one embodiment, a photodetector detects a first light transmittance of a fluid at a first gain level and generates a transmittance signal. The 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 the transmittance signal and at least one of the first and second gain levels. The second gain level may be greater than or less than the first gain level. For example, the light transmittance (U) over time (t) IN ) and gain (U OUT Referring to Figure 29, which shows the gain at the first gain level (U1), the light transmittance is first measured at point A, which is a predetermined transmittance threshold (U TThe gain level increases to exceed ). 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 based on the fluid transmittance or another sensing parameter. Subsequently, the blood concentration decreases further, but then increases so that the light transmittance decreases 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. The adjustment of the gain level between the first and second gain levels may be performed in each instance where the light transmittance passes a predetermined transmittance threshold. It is understood that there may be two or more predetermined transmittance thresholds so that three or more different gain levels can be achieved. Furthermore, as shown in Figure 28, the gain can be selectively changed as needed by using an analog switch controlled by a microcontroller and a plurality of resistors.

[0088] When the light transmittance varies over a predetermined transmittance threshold, the gain may be adjusted excessively repeatedly. To avoid excessive switching of the gain level, a level of hysteresis may be included. An exemplary solution for providing the aforementioned gain adjustment with less "noise" is shown in Figure 30, where a first predetermined transmittance threshold (U T1 ) and a second predetermined transmittance threshold (U T2) is used. More specifically, the second predetermined transmittance threshold is greater than the first predetermined transmittance threshold, and as a result, the threshold for increasing the gain level is higher than the threshold for decreasing the gain level. For example, the gain is at the first gain level, and the light transmittance first increases to exceed the first predetermined transmittance threshold at point F. The gain level is not adjusted at point F, since the decrease in the gain level is limited to the measured light transmittance rising above the second predetermined transmittance threshold. The plot shows the light transmittance further increasing 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. The plot then shows that the blood concentration increases further and then decreases to below the second predetermined transmittance threshold at point J. The gain level is not adjusted at point J, since the increase in the gain level is limited to the measured light transmittance below the first predetermined transmittance threshold. The plot shows the light transmittance at point K, which further decreases until it falls below a first predetermined transmittance threshold. 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 three or more predetermined transmittance thresholds can be provided so that four or more different gain levels can be achieved.

[0089] The sensor assembly 70 is intended to have additional sensors that operate selectively based on the detected light transmittance. For example, one or more of the sensors can be calibrated to a low light transmittance, while others can be calibrated to a high light transmittance. Certain sensors can be set to operate by default. If the detected light transmittance decreases below a predetermined transmittance threshold, the controller 60 can selectively activate the sensor(s) calibrated to the low light transmittance. If the detected light transmittance returns to or increases above the predetermined transmittance threshold, the controller 60 can selectively activate the sensor(s) calibrated to the high light transmittance. Additionally or alternatively, the brightness of the emitters 96, 97 can be adjusted based on the detected light transmittance. For example, if the detected light transmittance decreases below a predetermined transmittance threshold, the controller 60 can increase the brightness of the light emitted from the emitters 96, 97 (or activate a brighter emitter). Conversely, if the detected light transmittance returns to or increases above a predetermined transmittance threshold, the controller 60 can reduce the brightness of the light emitted from the emitters 96, 97 (or deactivate the brighter emitter).

[0090] Referring here to Figure 31, the blood management system 39 may include a medical waste collection system 40, a sponge system 41, and a user interface 43. In its most comprehensive sense, the blood management system 39 utilizes systems 40, 41, and 43 to provide real-time quantification of patient blood loss, taking into account the different ways in which blood may be brought into the operating room. The compilation of data from systems 40, 41, and 43 advantageously provides real-time, accurate quantification of patient blood loss displayed on the user interface 43. The data can optionally be transferred to the patient's electronic medical record (EMR) 45. The improved accuracy provides more reliable visual and auditory alarms that can be provided to healthcare professionals in the event of excessive blood loss.

[0091] The blood management system 39 includes a medical waste collection system 40, which is described throughout this disclosure and forms part of this specification by reference. The medical waste collection system 40 can separate blood from other bulk fluids, and subsequent volume measurements are used for blood loss volume calculations. Additionally or alternatively, the medical waste collection system 40 can receive input from the user that only blood has been aspirated. For example, it is known to measure the volume of fluid after amniotic fluid collection. The fluid characterization module 68 is either integrated with the manifold 66 or detachably coupled to the manifold 66 and / or integrated with the medical waste collection system 40 through one or more of the embodiments described herein.

[0092] The medical waste collection system 40 can perform QBL analysis and wirelessly transmit blood volume data to the user interface 43. Additionally or alternatively, the user interface 43, another device such as a mobile device, or a remote server may receive the data described herein, execute algorithms, and perform QBL analysis. The medical waste collection system 40 communicates electronically with the user interface 43. Exemplary forms of electronic communication include the Bluetooth Low Energy Protocol, as well as a local area network (LAN) to which the medical waste collection system 40 and the user interface 43 are wirelessly connected.

[0093] The sponge system 41 is configured to determine the volume of blood loss contained within an absorbent article, such as a surgical sponge. One exemplary sponge system is marketed under the trade name SurgiCount by Stryker Corporation (Kalamazoo, Michigan). The sponge system 41 includes a stand having onboard components for calculating blood loss parameters. The stand includes one or more detection devices and one or more mass measuring devices. In an exemplary embodiment, the detection device is a code reader and the mass measuring device is a load cell.

[0094] In another embodiment, the mass measuring device may be a container assembly for absorbent articles having an embedded load cell for weighing the absorbent articles. This container assembly may also include electronic equipment configured to detect the absorbent articles within the container assembly. When absorbent articles are detected, information is sent to a processor to identify them by part number and dry weight from a pre-programmed dataset.

[0095] Once the blood loss volume data is displayed, the bag or other storage container may be physically supported on or by the mass measuring device. The bag may contain a scannable code associated with its part number and dry weight. When absorbent articles(s) are introduced into the bag, the scannable code placed on the absorbent articles is scanned by a code reader. The database contains the part number and dry weight of the absorbent articles. The mass measuring device measures the total weight and subtracts the dry weight(s) of the absorbent articles(s) to calculate the weight of the absorbed fluid. From the weight of the blood and a known density, the absorbed blood loss volume can be calculated. The sponge system 41 communicates electronically with the user interface 43, and the sponge system 41 can transmit the blood loss volume to the user interface 43 wirelessly or via a wired connection.

[0096] In another embodiment, the accuracy of the dry weight can be improved by measuring the mass of the bag or absorbent article during manufacturing, and the measured mass(s) may be stored in a pre-programmed dataset of, for example, an RFID tag 216. The measured mass may be based on the measured lot or pack average mass.

[0097] The user interface 43 functions as a hub for providing acute patient information to healthcare professionals. The volume of blood loss can be displayed in real time on the control panel 58 and / or the user interface 43 throughout the procedure. The volume of blood loss can also be displayed as a graph plot over time since the start of the procedure. In an exemplary embodiment, the user interface 43 is a tablet with a touchscreen display that shows all desirable information, such as aspirated blood loss volume, absorbed blood loss volume, alarms, warnings, and all other important information. For example, the blood loss rate can be used to trigger an alarm and warn healthcare staff of a high blood loss rate, and thus the possibility of postpartum hemorrhage. The user interface 43 displays the patient's total blood loss by combining all relevant data. Alarms or warnings may be based on thresholds or guidelines that are wirelessly pushed to the user interface 43. Thresholds may be predetermined by the manufacturer, implemented based on healthcare facility protocols, or obtained through clinical or other guidelines. Guidelines may be based on external clinical organizations, artificial intelligence determination from clinical data mining, or other sources. Additional alerts may be generated based on the blood loss rate. Furthermore, the touchscreen display is configured to receive user input, particularly qualitative input from healthcare professionals related to blood loss. Qualitative input may include estimates of blood loss volume visualized on the floor or additional absorbent material.

[0098] The volume of the irrigation fluid used during the procedure can also be entered into the touchscreen display if known. Additionally or alternatively, the irrigation fluid can be gravity-fed, supported by a system capable of measuring and / or communicating the mass or volume of the fluid used. The initial volume of the irrigation fluid can be entered, measured, and / or scanned. The irrigation system may include a load cell to measure the current mass for calculating the volume of the irrigation fluid used. Additionally or alternatively, if an electronic pump is used to deliver the irrigation fluid, the electronic pump can generate and transmit data indicating the volume of the irrigation fluid used.

[0099] Several embodiments have been discussed in the preceding description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terms used are intended to be descriptive, not restrictive. Many modifications and variations are possible in light of the above teachings, and the invention can be carried out in ways other than those described in detail.

[0100] Certain embodiments can be described with reference to the following exemplary items.

[0101] Item 1 - A manifold configured to be detachably coupled to a receiver of a medical waste collection system including a sensor assembly of a fluid characterization module and a vacuum source configured to generate a fluid suction path, comprising 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 detachably coupled to a suction tube, wherein the detection window is positioned to communicate optically with the sensor assembly when the manifold is detachably inserted into the receiver.

[0102] Item 2 - The manifold according to Item 1, wherein the detection window comprises a first window located on the upper surface of the first leg and a second window located on the lower surface of the first leg.

[0103] Item 3 - The outlet opening is located proximal to the detection window of the manifold described in Item 1 or 2.

[0104] Item 4 - A manifold according to any one of items 1 to 3, further comprising an arm extending outward from a first leg, wherein the proximal surface of the first leg is distal to a detection window.

[0105] Item 5 - A manifold according to any one of items 1 to 4, further comprising a catch positioned on a second leg, the distally oriented face of the catch positioned proximal to the detection window.

[0106] Item 6 - The catch and detection windows are separated by a gap, as described in Item 5 of the manifold.

[0107] Item 7 - A manifold as described in any one of items 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.

[0108] Item 8 - A manifold according to any one of items 1 to 7, further comprising a spine extending from a first leg, wherein the proximal surface of the spine is positioned distal to the detection window.

[0109] Item 9 - A manifold according to any one of items 1 to 8, further comprising a radio frequency identification (RFID) tag, at least partially positioned on a second leg, and containing memory for storing data.

[0110] Item 10 - A method for determining the volume of blood loss from a fluid collected through an aspiration path generated by a medical waste collection system, comprising the steps of: receiving a signal from a photodetector; executing an optical acquisition subroutine in which the concentration of blood in the fluid is determined based on the signal; executing a volume acquisition subroutine in which the volume of the collected fluid is measured or determined; and executing a blood volume calculation subroutine in which the volume of blood loss is determined based on the blood concentration and the volume of the collected fluid.

[0111] The method according to item 10, further comprising the step of executing a main routine which includes an optical acquisition subroutine, a volume acquisition subroutine, and a blood volume calculation subroutine, wherein the main routine further includes a calibration subroutine which calibrates a photodetector based on at least two different wavelengths of light.

[0112] The method according to item 10 or 11, further comprising the step of adjusting the gain of a photodetector based on the transmittance of light relative to a predetermined transmittance threshold, item 12 - Blood volume calculation subroutine.

[0113] Item 13 - Blood volume calculation subroutine, the method according to any one of items 10-12, further comprising the step of calculating the flow rate of the suction pathway.

[0114] Item 14 - A computer program product configured to perform any one of the methods described in items 10 through 13.

[0115] Item 15 - A medical waste collection system for collecting fluid through a manifold, comprising: a waste container; a vacuum source configured to generate a suction path; a receiver connected to the waste container and defining an opening configured into which a manifold is removably inserted; a fluid characterization module including a sensor assembly positioned to detect the optical properties of the fluid in the suction path; a processor configured to communicate with the sensor assembly and receive a blood concentration signal from the sensor assembly, along with a signal for determining blood volume loss in the fluid; and a fluid measuring assembly connected to the waste container and communicating with the processor, configured to measure the volume of the collected fluid, wherein the processor is configured to receive a fluid volume signal from the fluid measuring assembly, and the values ​​associated with the blood concentration signal and the fluid volume signal facilitate the quantification of blood loss volume.

[0116] Item 16 - A medical waste collection system according to Item 15, further comprising a flow sensor communicating with a controller, configured to measure the flow rate of a collected fluid, wherein the controller is configured to receive a flow signal from a fluid measuring assembly, and the values ​​associated with the blood concentration signal and the flow signal facilitate the quantification of blood loss volume.

[0117] Item 17 - A medical waste collection system according to Item 15 or 16, further comprising a mobile device including a processor.

[0118] Item 18 - A medical waste collection system for collecting waste fluid material through a manifold, comprising: a waste container; a vacuum source configured to provide a vacuum to the waste container; a receiver connected to the waste container and defining an opening into which a manifold is removably inserted, the receiver including an inlet mechanism movable in the proximal and distal directions; and a sensor assembly connected to the inlet mechanism and configured to detect the optical properties of a fluid passing through the manifold.

[0119] Item 19 - A medical waste collection system as described in Item 18, further comprising a processor configured to communicate with a sensor assembly and receive a characteristic signal from the sensor assembly, and to determine the blood concentration in a fluid from the signal.

[0120] Item 20 - A medical waste collection system according to Item 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 emitter positioned on the first support element.

[0121] Item 21 - The medical waste collection system according to Item 20, wherein the inlet mechanism further includes a second support element positioned spaced apart from the suction inlet and opposite to the first support element, and the sensor assembly includes a first sensor positioned on the second support element.

[0122] Item 22 - The medical waste collection system as described in Item 21, wherein the sensor assembly includes a second emitter positioned on a second support element.

[0123] Item 23 - A sensor assembly comprising a second sensor positioned on a first support element, as described in Item 22, for the medical waste collection system.

[0124] Item 24 - A medical waste collection system as described in any one of Items 18-23, wherein the inlet mechanism is configured to move in a proximal to distal direction while inserting the manifold into the receiver and while removing the manifold from the receiver.

[0125] Item 25 - A medical waste collection system for collecting waste fluid material through a manifold, comprising: a waste container; a vacuum source configured to provide a vacuum to the waste container; a receiver connected to the waste container and having an opening configured to allow a manifold to be removably inserted, and an inlet mechanism defining a receiver outlet and movable in the proximal and distal directions; and a sensor assembly connected to the receiver and positioned relative to the manifold to detect characteristics of a fluid passing through the manifold, the characteristics of which indicate blood concentration in the fluid.

[0126] Item 26 - A medical waste collection system for quantifying blood loss, comprising: a waste container; a vacuum source configured to provide a vacuum to the waste container; a fluid characterization module equipped with 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 configured to communicate with the photodetector, receive a transmittance signal from the photodetector, change a first gain level to a second gain level based on the transmittance signal, and determine the concentration of blood in the fluid based on the transmittance signal and at least one of the first and second gain levels.

[0127] Item 27 - The medical waste collection system according to claim 26, wherein the transmittance signal is above a first predetermined transmittance threshold and the second gain level is less than the first gain level.

[0128] Item 28 - A medical waste collection system according to item 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.

[0129] Item 29 - A medical waste collection system according to Item 27 or 28, further configured to determine whether the transmittance signal is above or below a second predetermined transmittance threshold which is less than a first predetermined transmittance threshold, and to change a second gain level to a first gain level or a third gain level if the transmittance signal is below the second predetermined transmittance threshold.

[0130] Item 30 - A manifold for quantifying blood in a fluid, configured to be positioned in fluid communication with a sensor assembly and vacuum source of a medical waste collection system, comprising a housing comprising a barrier separating a first fluid reservoir and a second fluid reservoir, and an inlet fitting, defining a first outlet opening in fluid communication with the first fluid reservoir and a second outlet opening in fluid communication with the second fluid reservoir; a first fluid level assembly disposed within the first fluid reservoir; a second fluid level assembly disposed within the second fluid reservoir; a distal flow directional member and a proximal flow directional member, the distal flow directional member and the proximal flow directional member being configured to be switchable to selectively direct fluid into one of the first fluid reservoir and the second fluid reservoir, and to selectively block fluid from being drawn through the same one of the first fluid reservoir and the second fluid reservoir.

[0131] Item 31 - The distal flow directionor is connected to the first fluid level assembly and the second fluid level assembly, as described in Item 30.

[0132] Item 32 - The proximal flow directionor is operably connected to the distal flow directionor in the manifold as described in Item 30 or 31.

[0133] Item 33 - The distal flow directionor and proximal flow directionor are electronically controlled valves, as described in Item 30.

[0134] Item 34 - A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, the manifold comprising: a housing comprising a head having an inlet fitting configured to be removably connected to a suction tube that draws fluid through the manifold under the influence of a vacuum from a vacuum source; a trunk connected to the head and including defining an outlet opening offset from the longitudinal axis of the manifold; and a filter element disposed within the housing, the manifold being optically transparent such that at least a portion of the head has a detection window configured to be positioned between the emitter and detector of an optical sensor assembly.

[0135] Item 35 - The manifold according to Item 34, wherein the housing defines a manifold volume and further comprises a projection defining a liquid reservoir below the manifold volume, the projection comprising a detection window.

[0136] Item 36 - The manifold according to Item 34 or 35, wherein the projection comprises a connecting feature configured to be removably connected to a fluid characterization module including an optical sensor assembly, and optionally the connecting feature comprises at least one rail configured to slidably engage with a slot in the fluid characterization module. Furthermore, the technical concepts that can be understood from the above embodiments are described below. [Aspect 1] A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising a main body, a first leg extending from the main body and having a rim defining an outlet opening, a second leg extending from the main body and spaced apart from the first leg to define a gap, and an inlet fitting configured to be detachably connected to a suction pipe that draws the fluid through the manifold under the influence of a vacuum from the vacuum source, A filter element arranged within the housing, Equipped with, A manifold in which at least a portion of the housing is optically transparent and includes a detection window configured to be positioned between the emitter and detector of an optical sensor assembly. [Aspect 2] The manifold according to embodiment 1, wherein the housing further comprises a trunk having a first leg and a second leg, and a head connected to the trunk and having the inlet joint, the head having the detection window. [Aspect 3] The manifold according to embodiment 1 or 2, wherein the housing defines a manifold volume and further comprises a projection defining a liquid reservoir below the manifold volume, and the projection comprises the detection window. [Aspect 4] The manifold according to embodiment 3, wherein the protruding portion comprises a connecting feature portion configured to be detachably connected to a fluid characteristics evaluation module including the optical sensor assembly. [Aspect 5] The manifold according to embodiment 4, wherein the connecting feature portion comprises at least one rail configured to slidably engage with a slot in the fluid characteristics evaluation module. [Aspect 6] The manifold according to any one of embodiments 3 to 5, wherein the protrusion has a width of 3 / 4 of an inch or less. [Aspect 7] The manifold according to any one of embodiments 3 to 5, wherein the filter element is a first filter element disposed within the manifold volume, and the manifold further comprises a second filter element disposed within the liquid reservoir. [Aspect 8] The manifold according to embodiment 7, further comprising a straw having a first end positioned near the base of the liquid reservoir and a second end positioned within the manifold volume. [Aspect 9] The manifold according to embodiment 8, wherein the straw extends through the second filter element. [Aspect 10] The manifold according to any one of embodiments 1 to 9, further comprising a fluid directionor disposed within the housing, wherein the fluid directionor has a geometric shape configured to provide a meandering path for the fluid in the manifold. [Aspect 11] The manifold according to embodiment 10, wherein the fluid directional member is positioned above the detection window and comprises a barrier defining a liquid inlet configured to facilitate the accumulation of the fluid in the housing while gas in the fluid separates from liquid in the fluid. [Aspect 12] The manifold according to embodiment 11, wherein the fluid directionating member further defines a gas inlet positioned above the liquid inlet. [Aspect 13] The manifold according to embodiment 12, wherein the fluid directionating member further defines fluid outlets communicating with the liquid inlet and the gas inlet, respectively. [Aspect 14] The manifold according to any one of embodiments 10 to 13, wherein the filter element is positioned closer to the outlet opening with respect to the fluid direction member. [Aspect 15] The manifold according to any one of embodiments 10 to 14, wherein the fluid directionor is positioned closer to the outlet opening relative to the filter element. [Aspect 16] A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising a rim defining an outlet opening and an inlet fitting configured to be removably connected to a suction tube that draws the fluid through the manifold under the influence of a vacuum from the vacuum source, wherein at least a portion of the housing comprises a detection window configured to be optically transparent and positioned between the emitter and detector of an optical sensor assembly, A filter element arranged within the housing, A fluid directioning member having a geometric shape disposed within the housing and configured to provide a meandering path for the fluid in the manifold, A manifold equipped with this. [Aspect 17] The manifold according to embodiment 16, wherein the meandering path includes changing the fluid flow from the proximal direction to the distal direction. [Aspect 18] The manifold according to embodiment 16 or 17, wherein the filter element is positioned closer to the inlet fitting with respect to the fluid directioning member so that the fluid is filtered by the filter element before it encounters the detection window. [Aspect 19] The manifold according to any one of embodiments 16 to 18, wherein the fluid directionor defines a liquid inlet, a gas inlet positioned above the liquid inlet, and a fluid outlet communicating with the liquid inlet and the gas inlet, respectively. [Aspect 20] The manifold according to embodiment 19, wherein the fluid directional member comprises a first barrier positioned proximal to the inlet joint, configured to restrict turbulence of the fluid entering the manifold from the inlet joint. [Aspect 21] The manifold according to embodiment 20, wherein the fluid directional member further comprises a second barrier defining the liquid inlet, the second barrier defining the liquid inlet which is sized to facilitate the accumulation of the fluid within the housing while gas in the fluid separates from liquid in the fluid. [Aspect 22] The manifold according to any one of embodiments 19 to 21, wherein the housing defines a liquid reservoir, and the fluid directional member comprises a straw having a first end positioned near the base of the liquid reservoir and defining the liquid inlet, and a second end positioned near the top of the liquid reservoir. [Aspect 23] The manifold according to embodiment 22, wherein the filter element is a first filter element, and the manifold further comprises a second filter element disposed within the liquid reservoir. [Aspect 24] The manifold according to embodiment 23, wherein the straw extends through the second filter element. [Aspect 25] The manifold according to any one of embodiments 16 to 24, wherein the housing defines a liquid reservoir and includes a projection with the detection window, and the fluid directioning member further defines a central or lateral channel communicating with the liquid reservoir. [Aspect 26] A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising a rim defining a manifold volume and an outlet opening, an inlet fitting configured to be detachably connected to a suction pipe, and a projection defining a liquid reservoir below the manifold volume, wherein at least a portion of the projection is optically transparent and includes a detection window configured to be positioned between the emitter and detector of an optical sensor assembly, A filter element arranged within the manifold volume section, A manifold equipped with this. [Aspect 27] The manifold according to embodiment 26, wherein the filter element is positioned closer to the outlet opening with respect to the detection window. [Aspect 28] The manifold according to embodiment 26, wherein the detection window is positioned closer to the outlet opening with respect to the filter element. [Aspect 29] The manifold according to any one of embodiments 26 to 28, wherein the protruding portion comprises a connecting feature portion configured to be removably connected to a fluid characteristics evaluation module including the optical sensor assembly. [Aspect 30] The manifold according to embodiment 29, wherein the connecting feature portion comprises at least one rail configured to slidably engage with a slot in the fluid properties evaluation module. [Aspect 31] The manifold according to any one of embodiments 26 to 30, further comprising a second filter element disposed within the liquid reservoir. [Aspect 32] The manifold according to embodiment 31, further comprising a straw having a first end positioned near the base of the liquid reservoir and a second end positioned within the manifold volume. [Aspect 33] The manifold according to embodiment 32, wherein the straw extends through the second filter element. [Aspect 34] The manifold according to any one of embodiments 26 to 33, further comprising a fluid directional member positioned above the liquid reservoir and configured to facilitate the accumulation of the fluid in the manifold volume while gas in the fluid separates from the liquid in the fluid. [Aspect 35] The manifold according to embodiment 34, wherein the fluid directionating member defines a liquid inlet communicating with the liquid reservoir and a gas inlet positioned above the barrier. [Aspect 36] A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising a main body, a first leg extending from the main body and having a rim defining an outlet opening, a second leg extending from the main body and spaced apart from the first leg to define a gap, and an inlet fitting configured to be detachably connected to a suction pipe that draws the fluid through the manifold under the influence of a vacuum from the vacuum source, A filter element arranged within the housing, Equipped with, A manifold having at least a portion of the first leg comprising a detection window that is optically transparent and configured to be positioned between the emitter and detector of an optical sensor assembly. [Aspect 37] A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising: a main body; a first leg extending from the main body and having a rim defining an outlet opening; a second leg extending from the main body and spaced apart from the first leg to define a gap; a head defining an accessory sleeve configured to slidably receive an optical sensor assembly including an emitter and a detector; and an inlet fitting positioned on the head and configured to be detachably connected to a suction tube that draws the fluid through the manifold under the influence of a vacuum from the vacuum source; A filter element arranged within the housing, Equipped with, A manifold in which at least a portion of the accessory sleeve is optically transparent and includes a detection window configured to be positioned between the emitter and the detector. [Aspect 38] An assembly for quantifying blood in a fluid, The manifold described in embodiment 37, A fluid characteristics evaluation module comprising the optical sensor assembly described in embodiment 37, wherein the fluid characteristics evaluation module is configured to be slidably inserted into the accessory sleeve, An assembly comprising: [Aspect 39] The assembly according to embodiment 38, further comprising at least one of the fluid characteristics evaluation module, a rechargeable battery configured to supply power to the optical sensor assembly, and a communication module configured to wirelessly transmit signals to a receiver of the medical waste collection system or another electronic device. [Aspect 40] The manifold according to any one of embodiments 1 to 37, further comprising a radio frequency identification (RFID) tag disposed on the housing and having a memory for storing data indicating that the manifold is of a type used together with the optical sensor assembly to quantify blood loss. [Aspect 41] A medical waste collection system that quantifies blood loss, Waste containers and A vacuum source configured to provide a vacuum to the waste container in order to create a fluid suction path, A receiver that communicates with the vacuum source and defines an opening into which a manifold is removably inserted, A fluid characteristics evaluation module comprising an optical sensor assembly configured to be operably connected to the manifold, A processor that communicates with the optical sensor assembly, Receiving a blood concentration signal from the aforementioned optical sensor assembly, To determine the concentration of blood in the aforementioned fluid, A processor configured to perform the following: A medical waste collection system equipped with the following features. [Aspect 42] A fluid measuring assembly connected to the waste container and communicating with the processor, further comprising a fluid measuring assembly configured to measure the level of the fluid collected in the waste container, wherein the processor Receiving a fluid volume signal from the aforementioned fluid measurement assembly, The volume of the collected fluid is determined from the fluid volume signal, The volume of blood loss is determined from the determined blood concentration and the determined volume of the collected fluid, A medical waste collection system according to embodiment 41, further configured to perform the following: [Aspect 43] A flow sensor that communicates with the processor, further comprising a flow sensor configured to measure the flow rate of the collected fluid, wherein the processor Receiving a flow signal from the aforementioned flow sensor, The volume of the collected fluid is determined from the flow rate signal, The volume of blood loss is determined from the determined blood concentration and the determined volume of the collected fluid, A medical waste collection system according to embodiment 41, further configured to perform the following: [Aspect 44] A method for determining the concentration of blood in a fluid suction path of a medical waste collection system, comprising a processor, a first photodetector, and a second photodetector, The steps include using the processor to receive a first transmission measurement from the first photodetector, which indicates light transmitted through the fluid at a first wavelength, The steps include using the processor to receive a first scattering measurement from the first photodetector, which indicates light emitted at a second wavelength and scattered by the fluid, The steps include using the processor to receive a second transmission measurement from the second photodetector, which indicates the light transmitted through the fluid at a second wavelength, The steps include using the processor to receive a second scattering measurement from the second photodetector, which indicates the light emitted at a first wavelength and scattered by the fluid, A step of determining the concentration of the blood in the aspiration path based on the first transmission measurement, the first scattering measurement, the second transmission measurement, and the second scattering measurement using the processor, Methods that include... [Aspect 45] The method according to embodiment 44, wherein the medical waste collection system further comprises a first light-emitting diode (LED) and a second LED, and the method further comprises emitting light of a first wavelength from the first LED and emitting light of a second wavelength from the second LED. [Aspect 46] Using the aforementioned processor, a fluid level signal indicating the fluid level is received, Determining the fluid volume based on the aforementioned fluid level signal, The volume of blood loss is determined based on the determined fluid volume and the determined blood concentration. The method according to embodiment 44 or 45, further comprising the above. [Aspect 47] A computer program product that is executed on the processor to perform the method described in any one of embodiments 44 to 46. [Aspect 48] A medical waste collection system comprising: a waste container; a vacuum source configured to collect fluid into the waste container under suction; an optical sensor assembly; and a processor configured to determine the blood concentration in the fluid based on a signal from the optical sensor assembly, and to further determine the volume of aspirated blood loss based on the determined blood concentration. A sponge system configured to determine the parameters of absorbed blood loss, A user interface that electronically communicates with the aforementioned medical waste collection system and the aforementioned sponge system, Equipped with, A blood management system comprising a processor configured to calculate total blood loss based on the determined volume of aspirated blood loss and the parameters of absorbed blood, and a user interface configured to display the total blood loss. [Aspect 49] The blood management system according to embodiment 48, wherein the medical waste collection system further comprises a fluid measuring assembly configured to communicate with the processor and measure the level of the fluid collected in the waste container, the processor further configured to determine the volume of the aspirated fluid and, based on the determined volume of the aspirated fluid and the determined blood concentration, determine the volume of the aspirated blood loss. [Aspect 50] A fluid properties evaluation module configured to detect the properties of a fluid passing through an aspiration path, wherein the properties indicate the blood concentration in the fluid, A module housing configured to define a portion of the aforementioned suction path, A first emitter connected to the module housing and configured to emit light of a first wavelength from the first side of the attraction path, the first emitter being an infrared LED configured to emit light of a first wavelength in the range of 750 nanometers to 850 nanometers, A second emitter connected to the module housing and configured to emit light of a second wavelength from the second side of the attraction path opposite to the first side, the second emitter being a visible light LED configured to emit light of a second wavelength in the range of 490 nanometers to 590 nanometers, A first sensor connected to the module housing and configured to detect light emitted from the first emitter and transmitted through the attraction path, A second sensor connected to the module housing and configured to detect light emitted from the second emitter and transmitted through the attraction path, A fluid properties evaluation module equipped with the following features. [Aspect 51] The fluid property evaluation module according to embodiment 50, wherein the first sensor is further configured to detect light emitted from the second emitter and scattered by the suction path, and the second sensor is further configured to detect light emitted from the first emitter and scattered by the suction path. [Aspect 52] A third sensor connected to the module housing and configured to detect light emitted from the first emitter and scattered by the attraction path, A fourth sensor connected to the module housing and configured to detect light emitted from the second emitter and scattered by the attraction path, A fluid properties evaluation module according to embodiment 50 or 51, further comprising the above.

Claims

1. A manifold for quantifying blood in a fluid, configured to be removably inserted into a manifold receiver of a medical waste collection system including a vacuum source, A housing comprising a main body, a first leg extending from the main body and having a rim defining an outlet opening, a second leg extending from the main body and spaced apart from the first leg to define a gap, and an inlet fitting configured to be detachably connected to a suction pipe that draws the fluid through the manifold under the influence of a vacuum from the vacuum source, A filter element arranged within the housing, Equipped with, At least a portion of the housing is optically transparent and includes a detection window configured to be positioned between the emitter and detector of an optical sensor assembly. The housing comprises a manifold that defines a manifold volume and further includes a projection below the manifold volume that defines a liquid reservoir, the projection comprising the detection window.

2. The manifold according to claim 1, wherein the housing further comprises a trunk having a first leg and a second leg, and a head connected to the trunk and having an inlet joint, the head having the detection window.

3. The manifold according to claim 1, wherein the protruding portion comprises a connecting feature portion configured to be detachably connected to a fluid characteristics evaluation module including the optical sensor assembly.

4. The manifold according to claim 3, wherein the connecting feature portion comprises at least one rail configured to slidably engage with a slot in the fluid property evaluation module.

5. The manifold according to claim 1, wherein the filter element is a first filter element disposed within the manifold volume, and the manifold further comprises a second filter element disposed within the liquid reservoir.

6. The manifold according to claim 5, further comprising a straw having a first end positioned between the bottom of the liquid reservoir and the second filter element spaced apart from the bottom, and a second end positioned within the manifold volume.

7. The manifold according to claim 6, wherein the straw extends through the second filter element.

8. The manifold according to any one of claims 1 to 7, further comprising a fluid directionor disposed within the housing, wherein the fluid directionor has a geometric shape configured to provide a meandering path for the fluid in the manifold.

9. The manifold according to claim 8, wherein the fluid directionating member is positioned above the detection window and includes a barrier separating the manifold volume section from the liquid reservoir section, and the barrier and the housing cooperate to define a liquid inlet between the manifold volume section and the liquid reservoir section to facilitate the accumulation of the fluid in the housing while the gas in the fluid separates from the liquid in the fluid.

10. The manifold according to claim 9, wherein the fluid directionating member further defines a gas inlet positioned above the liquid inlet.

11. The manifold according to claim 10, wherein the fluid directionating member further defines fluid outlets communicating with the liquid inlet and the gas inlet, respectively.

12. The manifold according to claim 9, wherein the filter element is positioned closer to the outlet opening with respect to the fluid direction member.

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