DEVICE AND METHOD FOR ESTIMATING BLOOD CONSTITUENTS IN FLUID IN A CANISTER OF A MEDICAL WASTE COLLECTION SYSTEM - Patent application

Abstract

An insert and insert assembly for facilitating image-based identification of blood components in medical waste. Medical waste is collected in a waste canister of a medical waste collection system including a vacuum source, a fluid measurement subsystem, and a cleaning subsystem. The insert assembly includes a means for positioning the insert within the waste canister to space an imaging mechanism of the insert from an inner surface of the waste canister. The imaging mechanism may include a plurality of imaging surfaces in a side-by-side arrangement, each spaced a respective distance from the inner surface. The insert may include a flow surface configured to limit obstruction of pressurized fluid from the cleaning subsystem directed toward the imaging mechanism. The insert may define a slot providing fluid communication between a rear side and a front side of the insert.

Description

[Technical field]

[0001] The present invention relates to a device and method for estimating blood constituents in a fluid within a canister of a medical waste collection system.

[0002] [Priority claim] This application claims priority to and the entire benefit of U.S. Provisional Patent Application No. 63 / 321,415, filed March 18, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0003] Liquid, semi-solid, and / or solid waste materials are generated as by-products of surgical procedures. The medical waste may be removed from the surgical site through a suction tube under the influence of a vacuum provided by a medical waste collection system. The medical waste may be collected in a waste canister of the medical waste collection system and may include liquids such as blood, tissue fluid, mucus, irrigation fluid, etc. Summary of the Invention [Problem to be solved by the invention]

[0004] Identifying blood loss during surgery can be used to monitor the health of a patient during surgery. Advances in imaging and computing have led to the quantification of blood loss by capturing images of a fluid-containing medium, such as a canister. One such system is sold under the trademark Triton by Gauss Surgical Inc. (Menlo Park, Calif.) and is disclosed in commonly owned U.S. Patent No. 9,773,320, issued September 26, 2017, the entire contents of which are incorporated herein by reference. The system includes an insert within a freestanding canister, the insert configured to allow a thin layer of fluid to be located between the insert and the inner surface of the canister. The use of a freestanding canister consumes valuable space within the operating room, and the freestanding canister does not take advantage of certain features and subsystems integrated within the waste canister of a medical waste collection system. Thus, there is a need in the art to address the above-mentioned technical challenges. [Means for solving the problem]

[0005] The present disclosure is directed to a device and method for quantifying blood components in medical waste disposed in a waste canister of a medical waste collection system. The waste canister defines a waste volume for receiving and collecting the waste material. A vacuum source may be supported on the chassis and configured to draw on the waste canister through one or more internal lines. The front casing defines at least one cutout or window to facilitate capture of an image of the waste canister with an optical sensor of a device such as a smartphone or tablet. The front casing may include a lip or portion that obscures a lower portion of the waste canister. The medical waste collection system includes a fluid measurement subsystem and a cleaning subsystem. The fluid measurement system is configured to measure a fluid level of the waste material disposed in the waste canister. Based on a signal received from the fluid measurement subsystem, the controller is configured to determine a fluid volume of the waste material in the waste canister. The controller can determine the amount of blood in the waste canister based on the determined fluid amount and the blood components determined by the controller through image-based processing. The cleaning subsystem includes a sprayer rotatably disposed within the waste canister, the sprayer configured to direct pressurized liquid against an interior surface of the waste canister. The canister light can be configured to illuminate the interior of the waste canister.

[0006] An insert is placed within the waste canister. The insert includes several geometric shapes, at least one of which is an imaging feature configured to be spaced apart from the interior surface of the waste canister to define a gap of a known and fixed distance. This gap allows a thin layer of fluid to be disposed between the insert and the interior surface of the waste canister. The insert generally includes a front side opposite a back side. The insert may include a top side, a bottom side, and multiple side surfaces extending between the front side and the back side.

[0007] The imaging mechanism includes a first imaging surface and, optionally, a second imaging surface. The first imaging surface is spaced a first distance from the inner surface, and the second imaging surface is spaced a second distance from the inner surface. The second distance can be greater than the first distance. The first and second imaging surfaces can be laterally disposed next to each other (in a side-by-side arrangement). The first and second imaging surfaces are separated by a ridge having a thickness equal to the difference between the first and second distances. The imaging mechanism can be square or rectangular, and each of the first and second imaging surfaces can be square or rectangular. Alternatively, the insert can include three, four, five or more imaging surfaces. In another variation, the imaging mechanism is formed from a single surface having a tapered profile between the sides of the insert. The thickness of the first of the sides is greater than the thickness of the second of the sides.

[0008] The lower aspect may include a front surface configured to be positioned adjacent or in abutting relationship with an inner surface of the waste canister. The first and second imaging surfaces may be recessed from the front surface of the lower aspect. The upper aspect may extend downward from the upper surface and include a front surface configured to be positioned adjacent or in abutting relationship with an inner surface of the waste canister. The front surface of the upper aspect may be the same shape as the front surface of the lower aspect, e.g., contoured to the curvature of the inner surface. The imaging mechanism may be recessed from the front surface of the upper aspect. The imaging mechanism may be located between the lower and upper aspects. The upper aspect may be at least equal in size to a fiducial marker configured to be detected by the optical sensor when capturing an image of the waste canister. The height of the lower aspect may be sized to place the imaging mechanism above the lip and within the window.

[0009] The lateral positioning of the first and second imaging surfaces can be based on a rotational direction of a sprayer of the cleaning subsystem. The first and second imaging surfaces can be positioned such that pressurized liquid contacts the first imaging surface before contacting the second imaging surface. In certain implementations, the insert can include a flow surface configured to direct pressurized liquid from the cleaning subsystem toward the imaging surface. The flow surface can be associated with an upper aspect and can slope downward and radially outward. Additional geometries can be associated with the flow surface, for example, channels, lumens, and undulations.

[0010] In certain implementations, the insert can define a slot that provides fluid communication from the rear side to the front side. The slot can be disposed widthwise along the insert and above the imaging mechanism. The upper aspect can define a channel that extends between a top surface of the insert and the slot.

[0011] The insert may be provided in an insert assembly. The insert assembly includes a means for supporting the insert within the waste canister to position the imaging mechanism and maintain the position of the imaging mechanism. The means for supporting the insert may couple the insert assembly to an upper cap of the waste canister, a lower portion of the waste canister, a sidewall of the waste canister, or combinations thereof. Implementations of the insert and the means for supporting the insert within the waste canister are interchangeable.

[0012] The insert assembly may include a mounting head, a strut, and an insert. The mounting head is configured to be secured to the upper cap. The strut may be a resiliently flexible plate or a pair of resiliently flexible rods. The strut may be biased to urge the insert into direct contact with the inner surface with the mounting head secured to the upper cap. The rod is coupled to a side of the insert, which provides a fulcrum to allow the insert to pivot to maintain optimal contact between the insert and the inner surface. The front side of the insert may include a plurality of feet. The depth (length) of the plurality of feet may define a gap between the imaging mechanism and the inner surface. The plurality of feet may be in a triangular arrangement.

[0013] In certain implementations, the insert assembly includes a coupler housing, at least one magnet, and an insert. The coupler housing can be contoured to an exterior surface and bottom of the waste canister. The coupler housing can be aligned with at least one rib of the waste canister. An upper member of the coupler housing can be disposed transversely relative to the insert. The insert can include a post or dimple that directly contacts the interior surface and further supports the insert in a desired position.

[0014] In certain implementations, an insert assembly is secured to a sensor rod of a fluid measurement subsystem. The insert assembly can include a flange extending from the insert and coupled to a mounting hub, the mounting hub defining an opening sized larger than the sensor rod. A locking member can secure the mounting hub to the sensor rod. The insert is prevented from rotating, thereby locking it in a desired position.

[0015] In a particular implementation, the insert assembly includes a frame. The frame can include a lower support ring, an upper support ring, and a number of braces that securely fasten the upper support ring to the lower support ring. The insert is fixedly coupled to the frame. The braces can have a height defined between the lower support ring and the upper support ring to approximate the height of the waste canister. In one variation, the lower support ring includes a front feature having a height sized to position the imaging mechanism above the lip and within the window. The front feature can also include a mounting portion configured to secure the insert to the frame. In another variation, a number of resilient tongues extend upwardly from the lower support ring. The tongues are sized and oriented relative to the lower support ring to resiliently deform inwardly when the frame is mounted within the waste canister. In yet another variation, the lower support ring defines a number of apertures configured to threadably receive set screws.

[0016] In certain implementations, the insert assembly includes a turnbuckle that secures the insert within the waste canister. The turnbuckle movably couples the front mount to the back mount. The front mount can include a contoured front surface to match the inner surface of the waste canister. The imaging mechanism can be disposed laterally relative to the front mount, although other suitable arrangements are contemplated.

[0017] In certain implementations, an adhesive is used to attach the insert within the waste canister. The insert assembly includes at least one leg coupled to or integrally formed with the insert. The leg is configured to be attached to the waste canister to position the first imaging surface a first distance from the inner surface. The legs can be pairs of legs spaced apart vertically along the body.

[0018] Thus, according to a first aspect of the present disclosure, an insert assembly includes an insert and a means for positioning the insert within a waste canister. The insert comprises an imaging mechanism configured to be imaged with an optical sensor such that the image is processed to quantify blood components. The imaging mechanism comprises a first imaging surface and a second imaging surface. The means for positioning the insert within the waste canister engages a front side of the insert with an inner surface of the waste canister. The means further provides for spacing the first imaging surface from the inner surface a first distance and spacing the second imaging surface from the inner surface a second distance greater than the first distance. The first imaging surface and the second imaging surface are laterally disposed adjacent one another.

[0019] The first distance may be in the range of 1.2 to 3.7 millimeters and the second distance is in the range of 1.7 to 4.2 millimeters. The first and second imaging surfaces may be separated by a ridge having a thickness equal to the difference between the first and second distances. The thickness of the ridge may be about 0.5 millimeters.

[0020] The insert may further include at least three feet extending forward of the imaging mechanism and configured to directly contact an inner surface of the waste canister. The feet may be in a triangular arrangement to enable wobble and vertical self-centering of the insert relative to the inner surface of the waste canister. The insert defines at least one cavity extending inwardly from a rear side opposite the front side.

[0021] The means for positioning the insert within the waste canister may include a mounting head configured to be coupled to an upper cap of the waste canister and a strut coupling the mounting head with the insert, the strut being biased or shaped to urge the insert into direct contact with an inner surface of the waste canister. The strut may be a plate or a pair of rods. The rods may be coupled to one another via a cross member in a U-shaped arrangement. The insert may define at least one slot, the strut being pivotally disposed within the slot to allow the insert to pivot about the strut. Alternatively, the means for positioning the insert within the waste canister may include at least one of a magnet, a locking member, a frame, a tongue, a turnbuckle, and an adhesive.

[0022] In certain implementations, the insert includes a lower aspect defined between a lower surface of the insert and the imaging mechanism. The lower aspect is sized relative to a lip of the medical waste collection system to position the imaging mechanism within a window of the medical waste collection system through which the waste canister is visible. The insert includes an upper aspect defined between a top surface of the insert and the imaging mechanism. The imaging mechanism may be recessed from the upper aspect.

[0023] The first imaging surface may be positioned relative to the second imaging surface based on an orientation of the rotatable sprayer to strike the pressurized liquid prior to the second imaging surface. The insert may include a flow surface configured to direct pressurized liquid from the cleaning subsystem toward the imaging mechanism. The flow surface may be tilted and oriented to be aligned with an incoming direction of the pressurized liquid. A slot may be disposed above the imaging mechanism, and the slot may be configured to provide fluid communication from a rear side to a front side of the insert. The upper aspect may define a channel extending between a top surface of the insert and the slot.

[0024] According to a second aspect of the present disclosure, an insert assembly includes a mounting head configured to be coupled to an upper cap of a waste canister and a strut coupled to the mounting head. An insert is coupled to the strut and includes an imaging mechanism configured to be imaged with an optical sensor such that the image is processed to quantify a blood component. The strut is biased or shaped to space the imaging mechanism away from the interior surface and urge the insert into direct contact with the interior surface of the waste canister.

[0025] According to a third aspect of the present disclosure, an insert assembly includes an insert and a means for positioning the insert within a waste canister, the means engaging a front side of the insert with an inner surface of the waste canister and spacing an imaging mechanism from the inner surface. The insert includes an imaging mechanism configured to be imaged with an optical sensor such that the image is processed to quantify blood components. The imaging mechanism has a tapered profile extending between opposing sides of the insert. [Brief description of the drawings]

[0026] [Figure 1] 1 is a diagram of a medical waste collection system configured to removably receive the manifold, which draws medical waste through a suction line and a manifold, where it is collected in a waste canister. [Diagram 2] 2 is a diagram of the medical waste collection system of FIG. 1 with the front casing removed. The optical sensor is configured to capture images of the waste canister and an insert disposed within the waste canister. The optical sensor may be on a mobile device. [Diagram 3] FIG. 2 is a perspective view of an implementation of the insert. [Figure 4] FIG. 13 is a perspective view of another implementation of the insert. [Figure 5A] FIG. 4 is a perspective view of an implementation of an insert assembly including the insert of FIG. 3. [Figure 5B]FIG. 5B is a perspective view of the insert assembly of FIG. 5A positioned within a waste canister. [Figure 6A] FIG. 13 is a perspective view of another implementation of an insert assembly disposed within a waste canister. [Figure 6B] FIG. 6B is a rear perspective view of the insert assembly of FIG. 6A. [Figure 6C] FIG. 6B is a top perspective view of a variation of the insert of FIG. 6A. [Figure 7A] FIG. 13 is a perspective view of another implementation of an insert assembly disposed within a waste canister. [Figure 7B] FIG. 7B is a perspective view of the insert assembly of FIG. 7A positioned within a waste canister. [Figure 8A] FIG. 13 is a perspective view of another implementation of an insert assembly disposed within a waste canister. [Figure 8B] FIG. 8B is a bottom view of the arrangement of FIG. 8A, in which the coupler housing of the insert assembly is supported against a rib of the waste canister. [Figure 8C] 8B is a perspective view of the arrangement of FIG 8A, in which fiducial markers are attached to the waste canister. [Figure 9A] 5 is an exploded perspective view of another implementation of an insert assembly including the insert of FIG. 4. [Figure 9B] FIG. 9B is a perspective view of the insert assembly of FIG. 9A positioned within a waste canister with a fiducial marker attached to the waste canister. [Figure 10A] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 10B] FIG. 10B is a perspective view of the insert assembly of FIG. 10A positioned within a waste canister. [Figure 11] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 12] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 13] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 14]FIG. 14 is a rear perspective view of the insert of FIGS. 11-13, where the slot provides fluid communication to the imaging mechanism of the insert. [Figure 15A] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 15B] FIG. 15B is a perspective view of the insert assembly of FIG. 15A positioned within a waste canister. [Figure 16A] FIG. 13 is a perspective view of another implementation of the insert assembly. [Figure 16B] FIG. 16B is a perspective view of the insert assembly of FIG. 16A positioned within a waste canister. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] 1 and 2 show a medical waste collection system 20 for collecting waste materials generated during a medical procedure. The waste materials may include semi-solid and solid materials such as tissue, as well as liquid materials such as blood mixed with irrigation fluid and other bodily fluids. The medical waste collection system 20 collects and stores the waste materials until it is necessary or desired to empty and dispose of the waste materials using a docking station. An exemplary docking station is disclosed in commonly owned U.S. Patent No. 7,401,898, issued Nov. 24, 2009, the entire contents of which are incorporated herein by reference.

[0028] The medical waste collection system 20 may include a chassis 22 and a number of wheels 24 for moving the chassis 22 along a floor surface within a medical facility. The medical waste collection system 20 includes at least one waste canister 26 that defines a waste volume for receiving and collecting waste material. A vacuum source 28 may be supported on the chassis 22 and configured to draw suction on the waste canister 26 through one or more internal lines. The vacuum source 28 may include a vacuum pump and a vacuum regulator supported on the chassis 22 and in fluid communication with the waste canister 26. The vacuum regulator is configured to adjust the level of suction drawn by the vacuum pump on the waste canister 26. Suitable structures and operation of several subsystems of the medical waste collection system 20 are disclosed in commonly owned U.S. Pat. No. 7,621,898, issued November 24, 2009, U.S. Pat. No. 10,105,470, issued October 23, 2018, and U.S. Pat. No. 11,160,909, issued November 2, 2021, which are incorporated herein by reference in their entireties.

[0029] The medical waste collection system 20 includes at least one receptacle 30 supported on the chassis 22. The receptacle 30 defines an opening sized to removably receive at least a portion of a manifold 32. A suction path can be established from a plurality of suction tubes 34 through the manifold 32 removably inserted into the receptacle 30 to the waste canister 26. In other words, a vacuum generated by the vacuum source 28 is drawn into the suction tubes 34, and waste at the surgical site is drawn through the manifold 32, through the receptacle 30, and into the waste canister 26. The manifold 32 may be a disposable component. Exemplary implementations of the receptacle 30 and manifold 32 are disclosed in commonly owned U.S. Pat. No. 10,471,188, issued Nov. 12, 2019, the entire contents of which are incorporated herein by reference.

[0030] The chassis 22 includes a front casing 36 that defines at least one cutout or window 38 that facilitates capture of an image of the waste canister 26 with an optical sensor 88. As shown diagrammatically in FIG. 2, the field of view of the optical sensor 88 includes the waste material collected in the waste canister 26. The optical sensor 88 may be on a mobile device 89. The optical properties of the waste material may be analyzed and processed to quantify blood components in the waste material. An exemplary method for quantifying blood components is disclosed in commonly owned U.S. Patent No. 8,792,693, issued July 29, 2014, the entire contents of which are incorporated herein by reference. The waste canister 26 may be formed from a transparent or optically clear material. The front casing 36 may include a lip or portion (generally identified as 40) that obscures a lower portion 54 of the waste canister 26.

[0031] Continuing with reference to FIG. 2, the medical waste collection system 20 includes a fluid measurement subsystem 42 configured to measure the fluid level of the waste material disposed in the waste canister 26. The fluid measurement subsystem 42 communicates with a controller 44 disposed on the chassis 22 (or another processor), or alternatively, processing of data can be performed remotely. An exemplary implementation of the fluid measurement subsystem 42 is disclosed in the above-mentioned U.S. Pat. No. 7,621,898, in which a float element 48 is movably disposed along a sensor rod 50 (see FIGS. 5B and 9B). Based on the signal received from the fluid measurement subsystem 42, the controller 44 is configured to determine the fluid volume of the waste material in the waste canister 26. The controller 44 can determine the amount of blood in the waste canister 26 based on the determined fluid volume and blood components determined by the controller 44 through image-based processing. The amount of blood in the waste canister 26 can be indicative of the patient's blood loss. The blood loss may be displayed on the user interface 46 located on the chassis 22 and / or on another user interface, such as the mobile device 89, or on another display. An alert may be provided via the user interface 46 if the patient's blood loss exceeds a predetermined or selected limit. Blood loss data associated with the medical procedure may be transmitted to an electronic medical record.

[0032] The medical waste collection system 20 includes a cleaning subsystem 52. An exemplary implementation of the cleaning subsystem 52 is disclosed in the aforementioned U.S. Patent No. 10,105,470, in which sprayers are rotatably disposed within the waste canister 26 and configured to direct pressurized liquid against an interior surface 60 of the waste canister 26. The cleaning subsystem 52 may be activated based on an input to the user interface 46 or upon docking of the medical waste collection system 20 with a docking station. The docking station may provide water and detergent that is directed through the sprayers to clean the waste canister 26, and may also empty the waste canister 26 during or upon completion of a cleaning cycle. Thereafter, a prefill pump (not identified) in fluid communication with a liquid container supported on the chassis 22 may be operated to direct prefill liquid to a lower portion 54 of the waste canister 26. The prefill liquid is at a level above the frusto-conical shape of the lower portion 54 (see FIGS. 6A and 7B), and the float element 48 of the fluid measurement subsystem 42 rises accordingly. The controller 44 tares or zeros the fluid measurement subsystem 42 above which the geometry of the waste canister 26 more closely resembles a cylinder for determining the quantity of waste material. Further disclosure regarding the operation of the prefill pump and fluid measurement subsystem 42 is provided in the aforementioned U.S. Patent No. 10,105,470.

[0033] The medical waste collection system 20 may also include a canister light 56 ​​configured to illuminate the interior of the waste canister 26. Any suitable placement of the canister light 56 ​​within the waste canister 26 is contemplated, with FIG. 2 being a non-limiting example. The canister light 56 ​​may be activated based on an input to the user interface 46 or an input to a device in communication with the controller 44. In addition to improving visibility to the operator, illumination of the waste canister 26 by the canister light 56 ​​may brighten the tint or hue (or other optical characteristic) of the waste components for improved image-based processing. For example, the intensity of light emitted from the canister light 56 ​​may be known and may be taken into account in image-based identification of blood components in the waste material.

[0034] Fluids with higher concentrations of hemoglobin (either as free or intracellular hemoglobin) are known to have a deeper red hue. Certain implementations of image-based identification of blood components estimate blood components (e.g., hemoglobin) in blood, and more generally in waste materials, by extracting redness or other color component values. Deeper red hues may result in color signal saturation, which may itself result in suboptimal readings and identification. Similarly, an excessively opaque fluid may result from a liquid containing excessively red blood cells with insufficient free hemoglobin, or from the lysis of an unknown portion of the total red blood cells. To ensure consistent and accurate image-based identification of blood components, the insert 58 is configured to be placed within the waste canister 26. The insert 58 includes several geometric shapes, at least one of which is spaced from an inner surface 60 of the waste canister 26 to define a gap of a known and fixed distance. This gap allows a thin layer of fluid to be located between the insert 58 and the interior surface 60 of the waste canister 26. Additionally, the insert 58 may be white or nearly white. With a white background against which the thin layer of fluid is placed, the fluid will exhibit an area of ​​at least substantially uniform color below the color intensity (e.g., color brightness) that would cause signal saturation. Unlike disposable, freestanding canisters, the insert 58 and the insert assembly 62 include features that allow the insert 58 to be integrated with the waste canister 26 of the medical waste collection system 20 of which it is a major component. In other words, the interior of the waste canister 26 is designed not to be easily accessible by untrained personnel. As a result, the insert 58 is configured to be reusable across multiple procedures, where the insert 58, which may be formed from white plastic, may be repeatedly exposed to blood, which induces staining. Deviations from the original color of the insert 58 may then result in inaccurate identification, and the insert 58 and the insert assembly 62 take such considerations into account.It is further noted that the integration of insert 58 with waste canister 26 provides real-time updates of blood loss and also improves sustainability by reducing environmental waste.

[0035] 3 and 4, an implementation of the insert 58 is shown, along with additional implementations described below. The insert 58 generally includes a front side 64 opposite a back side 66. Conventionally, the front side 64 is configured to be positioned adjacent to the inner surface 60 of the waste canister 26, and the back side 66 is opposite the front side 64. The insert 58 may include a top surface, a bottom surface, and a number of side surfaces 68 extending between the front side 64 and the back side 66. A lower aspect 70 may include a front surface 72 extending upwardly from the back side 68 and configured to be positioned adjacent or in abutting relationship with the inner surface 60 of the waste canister 26. An exemplary implementation includes the front surface 72 in direct contact with the inner surface 60.

[0036] The insert 58 further includes an imaging mechanism 74. The imaging mechanism 74 includes a first imaging surface 76 and, optionally, a second imaging surface 78. The first imaging surface 76 and the second imaging surface 78 are recessed from the front surface 72 of the lower aspect 70. With the front surface 72 in direct contact with the inner surface 60 of the waste canister 26, the first imaging surface 76 is spaced a first distance from the inner surface 60 and the second imaging surface 78 is spaced a second distance from the inner surface 60. The second distance can be greater than the first distance. In one example, the first distance is 1.7 millimeters and the second distance is 2.2 millimeters. It is more broadly contemplated that the first distance can be within a range of approximately 0.7 to 5.7 millimeters, more particularly within a range of 1.2 to 3.7 millimeters, and the second distance can be within a range of approximately 1.2 to 6.2 millimeters, more particularly within a range of 1.7 to 4.2 millimeters. The first and second distances allow a thin layer of fluid to be located between the first imaging surface 76 and the inner surface 60, and between the second imaging surface 78 and the inner surface 60. The thin layer of fluid is at least substantially uniform in color, and the controller 44 is configured to position an area of ​​the image associated with the imaging mechanism 74 for image-based identification of blood constituents. The second imaging surface 78 is optional (see FIGS. 6C and 11-16B), but is a predetermined geometric shape at the second distance that provides a gradient of increasing color intensity that is less than a color intensity that may cause signal saturation. The color gradient may be used by the controller 44 to improve image-based identification of blood constituents and further perform additional functions such as those disclosed in the above-mentioned U.S. Patent No. 9,773,320. It should be understood that the insert 58 can include two, three, four, five or more imaging surfaces, and the implementation shown is a non-limiting example.

[0037] The first imaging surface 76 and the second imaging surface 78 may be disposed laterally next to each other. In contrast to a stepped vertical arrangement, this laterally next to each other arrangement provides, among other advantages, a color gradient at lower fluid levels and improves the cleanability of the insert 58. FIGS. 3 and 4 show the first imaging surface 76 and the second imaging surface 78 separated by a ridge 80 having a thickness equal to the difference between the first distance and the second distance. For example, the ridge 80 may be about 0.5 millimeters. It is contemplated that the ridge 80 may be rounded or otherwise contoured for aesthetics, manufacturability, or function. Other geometries for the transition between the first imaging surface 76 and the second imaging surface 78 are contemplated.

[0038] The implementation of the insert 58 of FIG. 3 includes an upper aspect 82 extending downwardly from the top surface 68 and includes a front surface 84 configured to be positioned adjacent or in abutting relationship with the inner surface 60 of the waste canister 26. The front surface 84 of the upper aspect 82 may be the same shape as the front surface 72 of the lower aspect 70. The front surfaces 72, 84 may be contoured to match the inner diameter of the inner surface 60 to facilitate consistent positioning of the imaging mechanism 74 within the waste canister 26 and to limit inadvertent movement of the insert 58 relative to the waste canister 26. The imaging mechanism 74 may be recessed from the front surface 84 of the upper aspect 82. The imaging mechanism 74 may be positioned between the lower aspect 70 and the upper aspect 82. In such an arrangement, the imaging mechanism 74 may be square or rectangular.

[0039] The upper aspect 82 may be at least equal in size to a fiducial marker 86 (see FIGS. 8C and 9B) configured to be detected by an optical sensor 88 when capturing an image of the waste canister 26. The fiducial marker 86 facilitates (helps) the controller 44 to locate the region of the image associated with the imaging mechanism 74 and further provides color correction to compensate for variations in ambient light or other optical aberrations. An exemplary implementation of the fiducial marker 86 is disclosed in commonly owned U.S. Pat. No. 9,824,441, issued Nov. 21, 2017, the entire contents of which are incorporated herein by reference, in which a Quick Response (QR) Code is attached with an adhesive to an exterior surface of the waste canister 26 corresponding to the location of the upper aspect 82 of an insert 58 disposed within the waste canister 26. The QR Code may be printed to be red with a known red component value. The controller 44 can adjust the value based on the red component value detected in the captured image relative to the known red component value. Additionally, by positioning the upper aspect 82 behind and sized equal to or greater than the fiducial marker 86, image segmentation of the red QR Code® in images that may otherwise include a dark red colored fluid in the waste canister 26 is improved. It is contemplated that the fiducial marker 86 can be attached to the insert 58, and in particular to the upper aspect 82 of the insert 58. The fiducial marker 86 can include an adhesive backing, and an adhesive film can be disposed over the fiducial marker 86 and at least a portion of the insert 58. The adhesive film can cover the upper aspect 82, the imaging mechanism 74, and other geometric features of the insert 58. The adhesive film can provide a hydrophobic coating to help prevent staining of the insert 58.

[0040] Continuing to refer to FIG. 3, the insert 58 is rectangular in shape with a height greater than its width. The thickness of the insert 58 defined between the front side 64 and the back side 66 is relatively small such that the insert 58 is a plate-like structure. The shape maximizes the surface area of ​​the front side 64 including the imaging mechanism 74 for a given volume of the insert 58. When the insert 58 is placed in the waste canister 26, the insert 58 consumes a portion of the waste volume of the waste canister 26. It is desirable to minimize the aforementioned consumed portion in order to limit its impact on the fluid measurement subsystem 42, particularly in implementations in which the insert 58 is retrofitted to an existing medical waste collection system. Alternatively, the insert volumes of inserts of various shapes and sizes may be stored in a database and selected on the user interface 46 at the time of installation. Based on the fluid level and the insert volume measured by the fluid measurement subsystem 42, the controller 44 may be configured to collate the consumed portion and calculate the fluid volume with improved accuracy.

[0041] 4, the insert 58 may include a flow surface 90 configured to direct pressurized liquid from the cleaning subsystem 52 toward the imaging mechanism 74, or at least to limit obstruction of pressurized liquid being directed from the cleaning subsystem 52 toward the inner surface 60 of the waste canister 26. A sprayer of the cleaning subsystem 52 is rotatably coupled to an upper cap 94 of the waste canister 26, where the sprayer directs liquid downwardly and radially outwardly (schematically represented by arrows) toward the inner surface 60. The flow surface 90 may be associated with the upper aspect 82 and may be angled downwardly and radially outwardly. In other words, the top surface 68 of the insert 58 may be thinned, with the insert 58 tapering outwardly toward the imaging mechanism 74. FIG. 4 illustrates the side surface 68 associated with the upper aspect 82 in a triangular shape. Due to the imaging mechanism 74 being spaced from the inner surface 60 of the waste canister 26, the flow surface 90 is also spaced from the inner surface 60, and spaced incrementally upward. Thus, during operation of the cleaning subsystem 52, the pressurized liquid can reach the upper edge of the imaging mechanism 74 at least largely unobstructed, maximizing its cleaning capability. The flow surface 90 can also provide a laminar flow of the pressurized liquid. The flow surface 90 can be provided at an angle α relative to the horizontal within a range of approximately 30-80 degrees, and more particularly within a range of 40-50 degrees. It is contemplated that additional geometries can be associated with the flow surface 90, for example, channels, lumens, and undulations. With the advantageous function of the flow surface 90, a thin layer of medical waste can be better washed out of the gap between the imaging mechanism 74 and the inner surface 60, and improved cleaning can limit staining or otherwise preserve the optical properties of the insert 58.

[0042] Although the first imaging surface 76 is shown to the right of the second imaging surface 78 (as viewed from the front side 64), an inverse configuration is contemplated. An inverse configuration may be provided for image-based processing considerations. In certain implementations, the inverse configuration may be based on the direction of rotation of the sprayer of the cleaning subsystem 52. More specifically, the first and second imaging surfaces 76, 78 may be positioned such that the pressurized liquid contacts the first imaging surface 76 (i.e., closer to the inner surface 60) before contacting the second imaging surface 78. If any semi-solid or solid debris is located between the insert 58 and the inner surface 60, the flow direction described above increases the likelihood of removing the debris (as opposed to urging the debris toward the face of the ridge 80). Additionally, the ridge 80 may be rounded or otherwise contoured to improve cleanability regardless of the flow direction, as described above. It should be appreciated that the flow surface 90 may also be utilized in implementations in which the imaging mechanism 74 does not include the second imaging surface 78 (see FIG. 15A).

[0043] The insert 58 may be provided on an insert assembly 92. In the broadest sense, the insert assembly 92 includes the insert 58 and means for supporting the insert 58 within the waste canister 26 to position and maintain the position of the imaging mechanism 74. The means for supporting the insert 58 may couple the insert assembly 92 to an upper cap 94 of the waste canister 26 (see FIGS. 5A-6A and 7B), a lower portion 54 of the waste canister 26 (see FIGS. 9A and 9B), a sidewall of the waste canister 26 (see FIGS. 8A-8C and 15A-16B), or a combination thereof (see FIGS. 10-15B).

[0044] The implementation of the insert assembly 92 of FIGS. 5-7B includes a mounting head 96, a strut 98, and an insert 58. The mounting head 96 is configured to be secured to the upper cap 94. The mounting head 96 can define at least one opening 100 configured to accommodate features of the upper cap 94, such as the sensor rod 50 of the fluid measurement subsystem 42 and the sprayer of the cleaning subsystem 52. One end of the strut 98 is coupled to the mounting head 96 and another end of the strut 98 is coupled to the insert 58. In the implementation of FIGS. 5A and 5B, the strut 98 is a resiliently flexible plate 102. The plate 102 is coupled to the insert 58 near the upper surface 68. The plate 102 is sized and oriented relative to the mounting head 96 and the insert 58 such that, with the mounting head 96 secured to the upper cap 94, the insert 58 is urged into direct contact with the inner surface 60. The plate 102 may be approximately perpendicular to the mounting head 96, and the insert 58 may be slightly angled relative to the plate 102 so that it is oriented vertically for flush contact between the lower and upper aspects 70, 82 and the inner surface 60. In the implementation of Figures 6A and 7A, the struts 98 are a pair of resiliently flexible rods 104. The rods 104 are also sized and oriented relative to the mounting head 96, the insert 58 such that, with the mounting head 96 secured to the upper cap 94, the insert 58 is urged into direct contact with the inner surface 60. The rods 104 are coupled to the side 68 of the insert 58 to provide a fulcrum. Due to the different structure, the rods 104 may exert a lower outward force on the insert 58 than that of the plate 102. The fulcrum allows the insert 58 to pivot to maintain optimal contact between the insert 58 and the inner surface 60. The insert 58 may be modified accordingly to further promote optimal contact. 6A and 7A show the front side 64 of the insert 58 including a number of feet 106. The depth (length) of the feet 106 can define the gap between the imaging mechanism 74 and the interior surface 60.The plurality of feet 106 are in a triangular arrangement and are sized relatively small to allow for wobbling when not all of the plurality of feet 106 are in direct contact with the inner surface 60. The connection between the rod 104 and the insert 58 can also allow for wobbling. The rod 104 urges the insert 58 toward the waste canister 26, and the wobble helps the insert 58 to "self-center" itself vertically with respect to the inner surface 60. It is contemplated that the less outward force of the rod 104 combined with the wobble may allow for temporary separation of the insert 58 from the inner surface 60 due to displacement by pressurized liquid during operation of the cleaning subsystem 52, thereby improving cleanability. It is noted that relative to the plate 102, the rod 104 obstructs a smaller amount of pressurized liquid being directed radially outward from the sprinkler above. Notably, the plurality of rods 104 are laterally spaced apart to avoid obstruction of the upper surface 68 of the insert 58. Thus, the flow surface 90 is well suited for the implementation of Figure 7 A. The struts 98 of the implementation of Figure 5 A may include a number of apertures or slots (not identified) configured to provide fluid communication through the plate 102, in which case the flow surface 90 may be provided.

[0045] 6A-6C, another implementation of the insert 58 and insert assembly 92 is shown, where the imaging mechanism 74 includes a first imaging surface 76 and a second imaging surface 78. The insert 58 is rectangular in shape with a width greater than its height. The thickness of the insert 58 defined between the front side 64 and the back side 66 is relatively large such that the insert 58 is a block-like structure. The increased thickness provides the insert 58 with greater rigidity against forces from turbulent flow and the like, and robustness within the waste canister 26. The insert 58 may define at least one cavity 164 extending forward from the back side 66 of the insert 58. FIG. 6B shows two cavities 164 separated by a barrier 166. The cavity 164 minimizes the volume of the insert 58 despite the relatively large thickness of the insert 58. As discussed above, it is desirable to minimize the portion volume consumed to limit the impact on the fluid measurement subsystem 42. The back side 66 may further define a slot 168 through the opposing side 68(s), and if a barrier 166 is present, the barrier 166 also has a slot 168 sized to receive a portion of the strut 98. The implementation shown shows the strut 98 in a U-shaped configuration with multiple rods 104 extending upwardly from a cross member that extends through the multiple slots 168. Figure 6A shows the first imaging plane 76 located to the left of the second imaging plane 78 (when viewed from the front side 64).

[0046] FIG. 6C illustrates a variation of the insert 58 of FIG. 6A, where the imaging mechanism 74 is formed from a single surface that tapers between the sides 68 of the insert 58. In other words, the thickness of a first one of the sides 68 is greater than the thickness of a second one of the sides 68. The feet 106 may be correspondingly sized to engage the inner surface 60 of the waste canister 26 to maintain a tapered profile of the imaging mechanism 74. With the feet 106 in direct contact with the inner surface 60 of the waste canister 26, the tapered profile of the imaging mechanism 74 is calibration data known to the controller 44. For example, the tapered profile may include that the minimum and maximum distances of the gap between the insert 58 and the inner surface 60 may be approximately 1.7 millimeters and 2.2 millimeters, respectively. Additionally, the tapered profile of the imaging mechanism 74 may facilitate debris removal and improved cleanability of the insert 58.

[0047] 8A-8C, an implementation of the insert assembly 92 includes a coupler housing 108, at least one magnet 110, and an insert 58. The magnet 110 is coupled to one of the coupler housing 108 and the insert 58, the other of which includes a ferromagnetic material. Figure 7A shows the coupler housing 108 generally formed with a pocket sized to accommodate the magnet 110.

[0048] The coupler housing 108 is contoured to match at least the exterior surface of the waste canister 26. The coupler housing 108 is further contoured to match the lower portion 54 of the waste canister 26 to facilitate consistent positioning of the insert 58. More specifically, the coupler housing 108 can include a lower member 112 that is flared and contoured to be flush with the lower portion 54, while an upper member 114 is flush with the exterior surface. One of the plurality of magnets 110 can be disposed on the lower member 112 and another of the plurality of magnets can be disposed on the upper member 114. The contour of the lower member 112 in combination with the plurality of magnets 110 can cause the coupler housing 108 to "self-align" with the complementary contour of the lower portion 54. With the insert 58 coupled to the coupler housing 108 at a fixed point (i.e., with the magnet 110), consistent positioning of the insert 58 relative to the inner surface 60 of the waste canister 26 can be more easily accomplished during installation, service, and replacement. Consistent positioning can include the lower edge of the imaging mechanism 74 accommodating a fluid volume of approximately 400 milliliters (as identified by volume markings on the waste canister 26 (see FIGS. 8C and 9B)). It is more broadly contemplated that the lower edge can accommodate a fluid volume within the range of approximately 100-1000 milliliters, and more particularly within the range of 200-600 milliliters.

[0049] Consistent positioning may be further achieved by aligning the coupler housing 108 with at least one rib 116 of the waste canister 26. As best shown in FIG. 8B, the bottom surface of the lower portion 54 of the waste canister 26 includes a plurality of ribs 116. The ribs 116 may provide strength to the frusto-conical shape of the lower portion 54. At least one of the plurality of ribs 116 may extend radially toward the front of the waste canister 26, i.e., the portion of the waste canister 26 that is visible through the window 38. Thus, the ribs 116 may be utilized to provide a rigid structure against which the coupler housing 108 may be positioned to radially position the insert 58 within the waste canister 26 in a consistent manner. FIG. 8B shows the edge of the lower member 112 that directly contacts the ribs 116.

[0050] The implementation shown shows the lower member 112 and upper member 114 in an L-configuration. Thus, the upper member 114 is positioned transversely to the insert 58, allowing liquid from the cleaning subsystem 52 to reach the flow surface 90 of the insert 58 without hindrance. The insert 58 may include posts 118 or dimples to directly contact the inner surface 60 and further support the insert 58 in a desired position. Other geometries and configurations of the coupler housing 108 and / or insert 58 are contemplated to provide the functionality described above with the magnets 110.

[0051] The insert 58 shown in Figures 9A and 9B is the same as that disclosed with reference to Figure 4 and is incorporated herein by reference. The insert assembly 92 is configured to secure the insert 58 to the sensor rod 50 of the fluid measurement subsystem 42. As can be seen generally in Figure 9B, the sensor rod 50 is off-center within the waste canister 26 and extends vertically from within the lower portion 54 to the upper cap 94. The insert assembly 92 includes a flange 120 extending from the insert 58 and coupled to a mounting hub 122. The flange 120 can extend from the lower surface 68, side surface 68, or another portion of the insert 58. The mounting hub 122 defines an opening 123 that is larger in size than the sensor rod 50. The mounting hub 122 is coupled to the sensor rod 50 at the lower portion 54 of the waste canister 26, and the flange 120 is contoured to position the insert 58 adjacent to or in abutting relationship with the inner surface 60.

[0052] The locking member 124 can secure the mounting hub 122 to the sensor rod 50. The locking member 124 defines an opening that is larger in size than the sensor rod 50 and a fastener configured to clamp the locking member 124 to the sensor rod 50. The locking member 124 and the mounting hub 122 include complementary orientation features 126 that are configured to engage with one another such that the mounting hub 122 is prevented from rotating about the sensor rod 50 when the locking member 124 is fastened to the sensor rod 50. Accordingly, the insert 58 is prevented from rotating and thereby locked in the desired position.

[0053] As mentioned above, the lip 40 of the front casing 36 of the chassis 22 may obscure at least the lower portion 54 of the waste canister 26. In other words, the window 38 of the front casing 36 may not extend far enough downward for the lower portion 54 to be visualized. With the implementation of the insert assembly 92 of Figures 9A and 9B supported within the lower portion 54 of the waste canister 26, the height of the lower aspect 70 defined between the lower surface 68 and the imaging mechanism 74 may be sized to extend beyond the lip 40 and to position the imaging mechanism 74 within the window 38. It should be understood that the lower aspect 70 is optional (see Figures 6A, 6B, 7A, 7B, 10A, 10B, 15A and 15B).

[0054] 10A-13, an implementation of the insert assembly 92 includes a frame 128 that can be self-supporting and self-locating within the waste canister 26. Such an implementation can be particularly suitable for retrofitting by requiring minimal or no modification or assembly to the waste canister 26. The frame 128 of FIGS. 10A and 10B includes a lower support ring 130, an upper support ring 132, and a number of braces 134 that securely fasten the upper support ring 132 to the lower support ring 130. The lower support ring 130 and the upper support ring 132 can be circular as shown, although other geometric shapes are contemplated. The insert 58 is fixedly coupled to the frame 128, and optionally, a stabilizer 136 can be coupled to the frame 128.

[0055] The outer diameter of the lower support ring 130 is sized to approximate the inner diameter of the waste canister 26 at a desired vertical position within the waste canister 26. In one example, the lower support ring 130 is sized to be disposed over the frusto-conical shape of the lower portion 54. Similarly, the inner diameter of the upper support ring 132 may be sized to approximate the inner diameter of the waste canister 26 at or near the upper cap 94 of the waste canister 26. Additionally, the brace 134 may have a height defined between the lower support ring 130 and the upper support ring 132 to approximate the height of the waste canister 26. With the insert assembly 92 disposed within the waste canister 26 and the upper cap 94 secured to the waste canister 26, the frame 128 is secured in place. Lateral movement is prevented by the stabilizer 136, and vertical movement is prevented by the lower portion 54 and the upper cap 94. The insert assembly 92 may include a mounting head 96 secured to the frame 128 if it is desired to mechanically couple the frame 128 to the upper cap 94. The insert 58 may be coupled to at least one of a plurality of braces 134 and / or to the lower support ring 130.

[0056] FIG. 11 illustrates a variation of the frame 128 in which the lower support ring 130 is a molded component and includes features 138 for improved attachment of the brace 134 and a front feature 140 for improved attachment of the insert 58. The front feature 140 can include a height sized to position the imaging mechanism 74 above the lip 40 and within the window 38. The front feature 140 can also include a mounting portion 142 configured to secure the insert 58 to the frame 128, for example, using an adhesive or another fastening means. The mounting portion 142 can extend upwardly a distance less than the height of the insert 58 such that the mounting portion 142 is not visible through the window 38. Similarly, the front feature 140, including the mounting portion 142, can be rotated clockwise about the lower support ring 130 about 90 degrees from the brace 134 such that little or none of the insert assembly 92 is visible through the window 38, other than the insert 58.

[0057] 12 shows another variation of the frame 128 in which a plurality of resilient tongues 144 extend upwardly from the lower support ring 130. The tongues 144 are sized and oriented relative to the lower support ring 130 to resiliently deform inwardly when the frame 128 is installed within the waste canister 26. The frictional force from the tongues 144 against the inner surface 60 of the waste canister 26 maintains the desired position of the insert 58.

[0058] 13 illustrates another variation of the frame 128 in which the lower support ring 130 defines a plurality of apertures 146 that are configured to threadably receive set screws. The set screws may be positioned in engagement with the inner surface 60 of the waste canister 26. The frame 128 does not include an upper support ring 132 or braces 134, thus minimizing the consumption of the insert assembly 92 into the waste volume of the waste canister 26.

[0059] 10A-13, and with further reference to FIG. 14, it is observed that implementations of the insert 58 do not include a flow surface 90, but rather include a front surface 84 contoured to match (and configured for direct contact with) the interior surface 60 of the waste canister 26. When the benefits of the flow surface 90 are not realized, pressurized liquid from the sprayer of the cleaning subsystem 52 may be prevented from cleaning the imaging mechanism 74 in an otherwise unimpeded manner. The insert 58 in these implementations may define a slot 148 that provides fluid communication from the rear side 66 to the front side 64 of the insert 58. As best shown in FIG. 14, the slot 148 may be disposed widthwise along the insert 58 and above the imaging mechanism 74. Additionally, the upper aspect 82 may define a channel 150 that extends between the top surface 68 of the insert 58 and the slot 148. The channel 150 is in fluid communication with the slot 148 and is configured to maximize the amount of pressurized liquid directed through the slot 148 that strikes the back side 66. With the slot 148 disposed above or adjacent to the imaging mechanism 74, the pressurized liquid passing through the slot 148 contacts the imaging mechanism 74 with minimal loss in fluid velocity. The retained fluid velocity can improve the cleanability of the insert 58. It is understood that the insert 58 including the slot 148 can be provided in any of the implementations of the insert assembly 92 as described throughout this disclosure.

[0060] 15A and 15B show another implementation of the insert assembly 92 in which a turnbuckle 152 secures the insert 58 within the waste canister 26. The turnbuckle 152 movably couples a front mount 154 to a rear mount 156. The front mount 154 may include a front surface 157 contoured to match the inner surface 60 of the waste canister 26. The imaging mechanism 74 may be disposed laterally relative to the front mount 154, although other suitable arrangements are contemplated. The flow surface 90 is disposed above the imaging mechanism 74. The turnbuckle 152 is operated in a known manner to urge the front mount 154 and rear mount 156 apart and into engagement with corresponding aspects of the inner surface 60 of the waste canister 26.

[0061] 16A and 16B show another implementation of an insert assembly 92 that mounts the insert 58 within the waste canister 26 using an adhesive. The insert assembly 92 includes at least one leg 158 that is coupled to or integrally formed with the insert 58. The leg 158 is configured to be attached to the waste canister 26 to position the first imaging surface 76 at a first distance from the inner surface 60. For example, each of the multiple legs 158 can include a foot 160 that includes a front surface of sufficient surface area to support the weight of the insert 58 using an adhesive. FIGS. 16A and 16B show an insert 58 that includes six legs 158 and six feet 160, with multiple pairs of legs 158 and feet 160 extending in opposite directions (on either side) from a body 162. More or fewer legs 158 can be provided, and the legs 158 can be arranged in any suitable configuration (e.g., asymmetric, angled, etc.).

[0062] The body 162 has a height defined between the upper and lower surfaces 68 that is sized to vertically traverse at least a majority of the height of the waste canister 26. The pairs of legs 158 are vertically spaced apart from one another along the body 162. While the illustrated implementation shows the pairs of legs 158 equally spaced apart from one another, alternatively the pairs of legs 158 may be weighted or stacked on the upper or lower portions of the body 162. The height of the body 162 provides the imaging mechanism 74 with a corresponding vertical traverse of at least a majority of the height of the waste canister 26. Thus, a thin layer of fluid may be present in larger volumes of waste material. The controller 44 may improve accuracy by using a larger portion of the image from the optical sensor 88 to perform the image-based identification of blood components, and / or the controller 44 may perform multiple image-based identifications, each corresponding to a predetermined region of the image along the body 162. Providing at least one additional fiducial marker 86' can facilitate (facilitate) locating additional predetermined regions of the imaging mechanism 74 to be analyzed. Multiple image-based locating can be averaged or otherwise adjusted. Such an arrangement can be particularly suitable where the waste material is heterogeneous, e.g., lighter colored, less dense perfusate is at least mildly separated from and located above darker colored, more dense blood. Additionally or alternatively, it is contemplated that an impeller can be operable within the waste canister 26 to mix the waste material to improve homogeneity.

[0063] It is further contemplated that additional fiducial markers may be placed on the insert 58, the waste canister 26, and / or other suitable locations in the system to provide light normalization in addition to locating the imaging mechanism 74. For example, three, four or more QR codes (or other fiducial markers) may be attached at multiple radial locations around the waste canister 26, thereby allowing accurate localization of the imaging mechanism 74 regardless of the location of the mobile device 89 relative to the waste canister 26, and allowing accurate normalization of ambient lighting. Another example includes attaching one or more additional fiducial markers to the top of the waste canister 26.

[0064] It should be appreciated that the implementations of the insert 58 discussed herein and the means for supporting the insert 58 within the waste canister 26 are replaceable. The insert 58 itself may be formed from a polymer, composite, or other suitable material. As discussed above, the material may be white, opaque, and impermeable to the fluid within the waste canister 26. The insert 58 may be fabricated from a highly reflective (i.e., glossy) material and / or coated with a glossy coating. Alternatively, the material may be non-white, transparent, and / or fluid permeable. The material and / or coating may be designed to be stain resistant for reusability of the insert assembly 92 over a period of time. For example, washability and stain resistant features may require replacement every three months, six months, nine months, or more. It is possible that the insert assembly 92 may not require replacement at all.

[0065] An exemplary method of quantifying a blood constituent using insert assembly 92 includes selecting a first region of the image that corresponds to a fluid layer between the inner surface 60 along a line of sight from optical sensor 88 and a first image plane 76 of imaging mechanism 74. Optionally, controller 44 may select a second region of the image that corresponds to a fluid layer between a second image plane 78 and the inner surface 60. The first and second regions may be selected based on a location of fiducial marker 86 in the image.

[0066] The first and second distances provide a color gradient. Color parameters may be extracted from the first and second regions. The color parameters are processed to identify the concentration of blood components in the waste material. Exemplary implementations of the above-mentioned U.S. Pat. No. 8,792,693 disclose using a parameter model or template matching algorithm to identify the concentration of blood components associated with the fluid in the canister. A hemolysis status of the blood in the waste canister may be identified.

[0067] The controller 44 determines the fluid volume of the waste material based on data received from the fluid measurement subsystem 42 and further determines the blood loss volume based on the concentration of blood components and the determined fluid volume. Because the fluid measurement subsystem 42 provides data to the controller 44 in real time, the determined blood loss volume can be automatically updated upon capture of new images with the optical sensor 88. It is further contemplated that the optical sensor 88 can be integrated into the chassis 22 of the medical waste collection system 20, where images of the waste canister 26 are captured continuously during the medical procedure or at regular intervals or selected times. The patient's blood loss volume can be updated in real time on the user interface 46 without operator involvement. Alternatively, the fluid volume can be manually entered on a mobile device 89 associated with the optical sensor 88 or on the user interface 46. The mobile device 89 can be a tablet, smartphone, digital camera, or the like.

[0068] The method may be computer-implemented by a machine configured to accept a non-transitory computer-readable medium storing computer-readable instructions. The computer-readable instructions may be executed by a computer-executable component integrated with at least one of an application, an applet, a host, a server, a network, a website, a communication service, a communication interface, hardware, firmware, software, and the like. The computer-readable medium may be stored on any suitable computer-readable medium, such as RAM, ROM, flash memory, EEPROM, optical devices, hard drives, floppy drives, and the like. The computer-executable component may be a processor (of the controller 44 or a separate processor), although any suitable hardware device may execute the computer-readable instructions.

[0069] Several implementations have been discussed in the above description. However, the implementations discussed herein are not intended to be exhaustive or to limit the invention to any particular form. Modifications and variations are possible in light of the above teachings and may be implemented differently than specifically described. For example, the blood components may be hemoglobin or may be one or more of whole blood, red blood cells, platelets, plasma, white blood cells, analytes, etc. The method may also be used to estimate the concentration and amount of non-blood components in the waste canister 26, such as saline, peritoneal fluid, bile, perfusate, saliva, gastric fluid, mucus, pleural fluid, tissue fluid, urine, feces (excrement), etc. The medical waste collection system 20 may communicate with other systems to form a fluid management ecosystem to generate a substantially comprehensive estimate of extracorporeal blood volume, total blood loss, euvolemic status of the patient, etc.

[0070] Certain inventive aspects of the present disclosure will be described with reference to the following exemplary clauses.

[0071] Clause 1 - An insert assembly for quantifying blood components in medical waste disposed within a waste canister of a medical waste collection system, the medical waste collection system further comprising a vacuum source and a cleaning subsystem including a rotatable sprayer for directing pressurized liquid toward an inner surface of the waste canister, the insert assembly comprising an insert having a front side, a back side, and an imaging mechanism including a first imaging surface configured to provide a first region of an image to be processed to quantify the blood components, and means for positioning the insert within the waste canister adjacent to or abutting the inner surface of the waste canister, the first imaging surface configured to be spaced a first distance from the inner surface of the waste canister, the insert further comprising a flow surface configured to direct pressurized liquid from the cleaning subsystem to the imaging mechanism or defining a slot configured to allow pressurized liquid to be directed from the cleaning subsystem to the imaging mechanism.

[0072] Clause 2 - The insert assembly of clause 1, wherein the slot provides fluid communication between the rear side and the front side of the insert.

[0073] Clause 3 - The insert assembly of clause 2, wherein the slot is positioned adjacent to and above the imaging mechanism.

[0074] Clause 4 - The insert assembly of clause 1, wherein the flow surface is inclined and oriented to match the direction of arrival of the pressurized liquid.

[0075] Clause 5 - An insert assembly described in any one of clauses 1 to 4, wherein the imaging mechanism further comprises a second imaging surface configured to be spaced a second distance greater than the first distance from the inner surface of the waste canister, and the first imaging surface is positioned laterally relative to the second imaging surface based on a rotational direction of a sprayer of the cleaning subsystem so as to strike the pressurized liquid prior to the second imaging surface.

[0076] Clause 6 - An insert assembly for quantifying blood components in medical waste disposed within a waste canister of a medical waste collection system further comprising a vacuum source, the insert assembly comprising: an insert having an imaging mechanism; and means for positioning the insert within the waste canister, the imaging mechanism configured to be imaged using an optical sensor so that the image is processed to quantify the blood components, and the means for positioning the insert within the waste canister engages a front side of the insert with an inner surface of the waste canister and spaces the imaging mechanism from the inner surface.

[0077] Clause 7 - The insert assembly of clause 6, wherein the means for positioning the insert within the waste canister comprises at least one of a flexible plate, a pair of flexible rods, a magnet, a locking member, a frame, a tongue, a turnbuckle, and an adhesive.

[0078] Clause 8 - A method for quantifying blood loss in medical waste in a waste canister of a medical waste collection system, the medical waste collection system including a vacuum source, a fluid measurement subsystem, an insert disposed within the waste canister, and a fiducial marker attached to the waste canister, the method including receiving an image of the waste canister, identifying a first region of the image based on the fiducial marker, identifying a concentration of a blood component in the waste material based on optical properties of the first region of the image, receiving data from the fluid measurement system indicative of a fluid level of the waste material in the waste canister, identifying a fluid volume of the waste material, and quantifying the blood loss based on the identified concentration of the blood component and the identified fluid volume.

Claims

1. An insert assembly for quantifying blood components in medical waste placed in a waste canister of a medical waste collection system, wherein the medical waste collection system includes a vacuum source. The aforementioned insert assembly is An insert equipped with an imaging mechanism, Means for positioning the insert within the waste canister, Equipped with, The imaging mechanism is configured to capture images using an optical sensor so that the images are processed in order to quantify the blood components. The imaging mechanism comprises a first imaging surface and a second imaging surface, The means for positioning the insert within the waste canister involves engaging the front side of the insert with the inner surface of the waste canister, separating the first imaging surface from the inner surface by a first distance, and separating the second imaging surface from the inner surface by a second distance greater than the first distance. An insert assembly in which the first imaging surface and the second imaging surface are arranged adjacent to each other in the lateral direction.

2. The insert assembly according to claim 1, wherein the imaging mechanism is rectangular, and each of the first imaging surface and the second imaging surface is square or rectangular.

3. The insert assembly according to claim 1, wherein the first distance is in the range of 1.2 to 3.7 millimeters, and the second distance is in the range of 1.7 to 4.2 millimeters.

4. The insert assembly according to claim 3, wherein the first imaging surface and the second imaging surface are separated by a ridge portion having a thickness equal to the difference between the first distance and the second distance.

5. The insert assembly according to claim 4, wherein the thickness of the ridge portion is approximately 0.5 millimeters.

6. The insert assembly according to any one of claims 1 to 5, further comprising at least three feet extending forward of the imaging mechanism, wherein the at least three feet are configured to directly contact the inner surface of the waste canister.

7. The insert assembly according to claim 6, wherein the at least three feet are arranged in a triangular configuration to allow the insert to swing and vertically self-center relative to the inner surface of the waste canister.

8. The insert assembly according to claim 1, wherein the insert defines at least one cavity extending inward from the rear side opposite to the front side.

9. The insert assembly according to claim 1, wherein the means for positioning the insert within the waste canister comprises a mounting head configured to be coupled to the upper cap of the waste canister, and a strut coupling the mounting head with the insert, wherein the strut is biased or formed to encourage the insert to come into direct contact with the inner surface of the waste canister.

10. The insert assembly according to claim 9, wherein the insert defines at least one slot, and the strut is rotatably positioned within the slot such that the insert can pivot around the strut.

11. The insert assembly according to claim 9, wherein the strut further comprises a plurality of rods connected to one another via a transverse member in a U-shaped arrangement.

12. The insert assembly according to claim 1, wherein the means for positioning the insert within the waste canister comprises at least one of a magnet, a locking member, a frame, a tongue-shaped portion, a turnbuckle, and an adhesive.

13. The insert assembly according to claim 1, further comprising a lower aspect defined between the lower surface of the insert and the imaging mechanism, wherein the lower aspect is sized such that the imaging mechanism is positioned within a window of the medical waste collection system relative to the lip of the medical waste collection system, and the waste canister is visible through the window.

14. The insert assembly according to claim 1, wherein the insert further comprises an upper aspect defined between the upper surface of the insert and the imaging mechanism, and the imaging mechanism is recessed from the upper aspect.

15. The insert assembly according to claim 1, wherein the medical waste collection system further comprises a cleaning subsystem having a rotatable sprayer for directing a pressurized liquid onto the inner surface of the waste canister, the first imaging surface being positioned relative to the second imaging surface based on the direction of the rotatable sprayer so as to strike the pressurized liquid prior to the second imaging surface.

16. The insert assembly according to claim 15, further comprising a flow surface configured to direct the pressurized liquid from the cleaning subsystem to the imaging mechanism.

17. The insert assembly according to claim 16, wherein the flow surface is inclined and oriented to match the direction of arrival of the pressurized liquid.

18. The insert assembly according to claim 15, wherein the insert defines a slot located above the imaging mechanism, and the slot is configured to provide fluid communication from the back side to the front side of the insert.

19. The insert assembly according to claim 18, wherein the upper aspect defines a channel extending between the upper surface of the insert and the slot.

20. An insert assembly for quantifying blood components in medical waste placed in a waste canister of a medical waste collection system, wherein the medical waste collection system further includes a vacuum source. The aforementioned insert assembly is A mounting head configured to be coupled to the upper cap of the waste canister, A strut coupled to the aforementioned mounting head, An insert coupled to the strut and equipped with an imaging mechanism, Equipped with, The imaging mechanism is configured to capture images using an optical sensor so that the images are processed in order to quantify the blood components. The insert assembly wherein the strut is biased or formed to move the imaging mechanism away from the inner surface of the waste canister and cause the insert to come into direct contact with the inner surface.

21. The insert assembly according to claim 20, wherein the insert defines at least one slot, the strut is rotatably positioned within the slot, and the slot is configured to allow the insert to pivot around the strut.

22. An insert assembly for quantifying blood components in medical waste placed in a waste canister of a medical waste collection system, wherein the medical waste collection system further includes a vacuum source. The aforementioned insert assembly is An insert equipped with an imaging mechanism, Means for positioning the insert within the waste canister, Equipped with, The imaging mechanism is configured to capture images using an optical sensor so that the images are processed in order to quantify the blood components. The imaging mechanism has a tapered outer shape extending between the opposing sides of the insert, The means for positioning the insert within the waste canister engages the front side of the insert with the inner surface of the waste canister, and separates the imaging mechanism from the inner surface. The means for positioning the insert comprises a plurality of feet extending from the front side of the insert, the plurality of feet configured to be in direct contact with the inner surface of the waste canister, and the plurality of feet having different lengths based on the tapered outer shape of the imaging mechanism, in the insert assembly.

23. The insert assembly according to claim 22, wherein the plurality of feet are arranged in a triangular configuration to allow the insert to swing and vertically self-center relative to the inner surface of the waste canister.

Images