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WO2025137561A1 - Cartridge, console, and methods for estimating blood loss in medical waste - Google Patents

Cartridge, console, and methods for estimating blood loss in medical waste Download PDF

Info

Publication number
WO2025137561A1
WO2025137561A1 PCT/US2024/061442 US2024061442W WO2025137561A1 WO 2025137561 A1 WO2025137561 A1 WO 2025137561A1 US 2024061442 W US2024061442 W US 2024061442W WO 2025137561 A1 WO2025137561 A1 WO 2025137561A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
fluid
conduit
housing
console
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/061442
Other languages
French (fr)
Inventor
Stephen FAUL
Bruce Mckee
David Eustace
Sean Mcmahon
Jeffrey KIRSCHENSTEINER
Jerry Huber ADAMS
Daniel VAN SLOOTEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Stryker Corp
Original Assignee
Stryker Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stryker Corp filed Critical Stryker Corp
Priority to CN202480030196.0A priority Critical patent/CN121079116A/en
Priority to AU2024408980A priority patent/AU2024408980A1/en
Publication of WO2025137561A1 publication Critical patent/WO2025137561A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/72Cassettes forming partially or totally the fluid circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/73Suction drainage systems comprising sensors or indicators for physical values
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • A61M2205/3313Optical measuring means used specific wavelengths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3379Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3382Upper level detectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers

Definitions

  • optical emitters and optical detectors Utilizing optical emitters and optical detectors to characterize properties of a fluid is established in the art.
  • Known arrangements have included optical emitters that emit a predetermined wavelength of light based on absorption characteristics of a substance of interest, namely blood or hemoglobin. Based on the absorption and scatter of the emitted light as detected by the optical detectors, certain properties of the fluid may be characterized.
  • One such system is disclosed in commonly-owned United States Patent Publication No. 2022/0008637, published January 13, 2022, the entire contents of which are hereby incorporated by reference, in which a sensor module is coupled to a conduit.
  • the present disclosure is directed to cartridges, systems and methods for estimating blood loss within medical waste.
  • implementations of the cartridge may define a fluid reservoir for the medical waste to be drawn into and collected therein, after which the liquid medical waste may buffer by permitting air to separate from the medical waste.
  • An external vacuum may be used to draw the medical waste into the cartridge.
  • the medical waste is further moved through conduits of the cartridge, for example, by a peristaltic pump of the console that is separate from the vacuum source.
  • the medical waste is moved through a detection window for analysis from a sensor assembly of the console.
  • the sensor assembly detects characteristics of the medical waste indicative of a concentration of a blood component within the medical waste, for example, hemoglobin.
  • the flow rate or volume of the medical waste being drawn through the cartridge may be determined by a sensor associated with the cartridge or the console, for example, an ultrasonic sensor or monitoring operation of the peristaltic pump.
  • the volume of the medical waste in combination of the blood component may be used to estimate the blood loss. This may be performed in an automated, semi-automated or manner, and/or in a continuous or intermittent manner.
  • the cartridge includes a first outlet fitting configured to be removably coupled with a first outlet suction tube operably coupled to an external vacuum source.
  • the external source may be on a medical waste collection system, and a manifold may be insertable therein as a sterile barrier.
  • the cartridge includes a conduit assembly.
  • the conduit assembly includes first and second conduits disposed within or formed with the housing, and a third conduit coupled to the housing and configured to engage the peristaltic pump of the console to move the liquid medical waste from the fluid reservoir, through the detection block, and to cither (i) the first conduit to be recirculated or (ii) to the second conduit to be purged.
  • the conduit assembly includes a conduit junction.
  • the first conduit provides fluid communication between the first outlet fitting and the conduit junction.
  • the second conduit provides fluid communication between the conduit junction and the fluid reservoir.
  • the third conduit provides fluid communication between the conduit junction and the detection block.
  • a sixth aspect of the present disclosure includes the plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining the void space configured to be aligned with the capacitive sensor of the console.
  • the barriers define a lower inlet opening between the fluid reservoir and the void space, a channel, a channel inlet opening, a channel outlet between the void space from the channel, and a channel outlet opening between the channel and the fluid reservoir.
  • the cartridge includes a float assembly disposed within the fluid reservoir.
  • the float assembly includes a float casing, a pivot pivotably coupling the float casing to the housing, and a magnetic element coupled to the float casing.
  • the float assembly includes a float casing having lateral sidewalls slidably positioned between opposing interior surfaces of the housing, an endwall extending between the lateral sidewalls, and protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste.
  • An eighth aspect of the present disclosure includes the conduit assembly having the first conduit, the second conduit, the third conduit, and a fourth conduit.
  • a method of performing a cleaning cycle with the cartridge includes operating the peristaltic pump with the cartridge in the recirculation mode in which the cleaning fluid is drawn from the fluid reservoir, through the detection window, through the conduit assembly, and into the fluid reservoir.
  • the first and second actuators of the console by the controller to move the cartridge from the recirculation mode to the purge mode in which the cleaning fluid is directed through the conduit assembly and through the first outlet fitting.
  • An optical characteristic of the cleaning passing through the detection window is detected with the sensor assembly.
  • a notification is provided on the display as to whether the cartridge is sufficiently clean for reuse based on the optical characteristic.
  • the housing further defines a compartment and an interior barrier separating the fluid reservoir and the compartment.
  • the first conduit and the second conduit may be disposed within the compartment, and the housing may include tube management geometries which extend from the interior barrier and into the compartment.
  • the housing may further include a first projection disposed within the compartment and aligned with the first lateral aperture, and a second projection disposed within the compartment and aligned with the second lateral aperture.
  • the first and second projections are configured to facilitate flow control-based pinching of a respective one of the exposed portions of the first and second conduits with actuation of a respective one of the first and second actuators of the console.
  • the first and second projections may include an arcuate face. Further, the first and second projections may extend from the interior barrier towards a respective one of the first and second lateral apertures.
  • the first and second actuators may be first and second pistons which are actuated by the console.
  • the cartridge may include a first weir arranged between the second conduit and the fluid reservoir, and a second weir arranged between the first conduit and the fourth conduit.
  • the weirs may be configured to be acted on by the actuators of the console to selectively move the cartridge between the fill mode and the purge mode. More specifically, the second weir may block fluid flow between the first conduit and the fourth conduit when depressed, and the cartridge may be configured to be in the fill mode when the first weir is unpressed and the second weir is depressed.
  • the fluid within the detection block may be analyzed by the sensor assembly of the console.
  • the detection block may include upper and lower surfaces respectively defining upper and lower openings that are aligned to form the detection window.
  • the detection block may further include a lateral surface extending between the upper and lower surfaces which defines a lateral opening that further forms the detection window.
  • the detection block may extend perpendicularly from an inner side of the housing.
  • the detection block may have a thickness defined between the upper and lower surfaces which is less than 1.0 centimeter.
  • the detection block may extend from an interior barrier of the housing.
  • the detection block may also include seals disposed at interfaces between the fluid channel and interior ports in fluid communication with the fluid reservoir and/or the conduit assembly.
  • the cartridge is configured to be reused only a certain amount of times and/or communicate usage parameters to the console.
  • the cartridge may include a radiofrequency identification tag coupled to the housing.
  • the cartridge may even include a first identification tag disposed on the housing and a second identification tag disposed on the detection block.
  • the detection block may be removably coupled to the housing to facilitate cleaning/replacement.
  • the plurality of barriers may include at least one of a lower barrier, an upper inner barrier, and an outer inner barrier.
  • the lower barrier may be ramped
  • the inner upper bander may be V-shaped
  • the outer upper barrier may be V-shaped and contoured to the inner upper barrier.
  • the inner upper banner may further define a channel inlet opening within the void space.
  • the channel inlet opening may be vertically aligned with the lower inlet opening.
  • the channel outlet opening may be horizontally aligned in elevation with the channel inlet opening.
  • the banners further may further include a first side barrier extending between the outer upper barrier and the lower inlet opening and/or a second side barrier extending between the inner upper barrier and the lower barrier.
  • the housing may include a front wall, a rear wall, and the opposing sidewalls, the inlet fitting and the outlet fitting may extend from the front wall, and the lower inlet opening may be positioned closest to the front wall relative of the void space.
  • the channel outlet opening may be positioned closest to the rear wall relative to the void space.
  • the outer upper barrier may define a channel outlet opening positioned external to the void space. The channel may be disposed above the channel outlet opening such that air or foam with the liquid medical waste is drawn into the void space under influence of vacuum as the liquid medical waste is being drawn out of the void space through the lower inlet opening during purging of the cartridge.
  • the console includes a plurality of capacitive sensors and the cartridge includes more than one foam shield to increase the accuracy of the capacitive sensors.
  • the float casing may further include stiffening members disposed within and extending between opposing sides.
  • the float casing may include lateral sidewalls separated by an endwall, with one of the lateral sidewalls is slidably positioned adjacent to an outer sidewall of the housing.
  • the lateral sidewalls may be planar and oriented parallel to one another.
  • the endwall may include an arcuate portion and two flat portions.
  • the float casing may define a recess into which the magnetic element is meant to be disposed, such as by a press fit engagement.
  • the float assembly may include protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste.
  • the protrusions may include conical or dome-shaped geometries, which may extend outwardly from the endwall of the float casing. Where the endwall includes the arcuate portion and flat portion(s), the geometries may extend outwardly from the flat portion(s).
  • the protrusions may include an elongate ridge extending outwardly from the lateral sidewalls. In this case, the elongate ridge may be arcuate in a direction of a sweeping motion of the float casing about the pivot.
  • the float casing may be substantially disc shaped.
  • the methods may further include determining, with the controller, that the cartridge is not sufficiently clean for reuse if the optical exceeds a predetermined threshold.
  • the console may include an identification reader to read an identification tag coupled to the cartridge. Data from the identification tag is received, wherein the data includes a number of uses of the cartridge. The number is compared against a predetermined number. A notification may be provided on the display that the cartridge is not sufficiently clean for reuse if the number of uses exceeds the predetermined number. A prompt may be provided on the display to inquire the cleaning cycle is desired if the number of uses does not exceed the predetermined number.
  • the method may further include iterating, with the controller, the number of uses associated with the cartridge during or after completion of the cleaning cycle, and the iterated number of uses may be written to the identification tag.
  • FIG. 1 is a front perspective view of an implementation of a medical waste collection system.
  • a console is situated on the medical waste collection system, and a cartridge is coupled to the console.
  • FIG. 2 is a front perspective view of the console and an implementation of the cartridge configured to be removably inserted therein.
  • FIG. 3 is a sectional view of the console of FIG. 2.
  • FIG. 4 is a front perspective view of an implementation of the cartridge.
  • FIG. 5 is an exploded view of an implementation of the cartridge of FIG. 4.
  • FIG. 6 is a partial view of the cartridge of FIG. 4 operating in a recirculation mode.
  • FIG. 7 is a partial view of the cartridge of FIG. 4 operating in a purge mode.
  • FIG. 8 is a front perspective view of another implementation of a cartridge.
  • FIG. 9 is a side elevation view of the cartridge of FIG. 8 with internal components shown in phantom.
  • FIG. 11 is a perspective view of the cartridge of FIG. 8 operating in a purge mode.
  • the cartridge 200 further includes a first outlet fitting 226 and a second outlet fitting 230 through which fluid may exit the cartridge 200.
  • the outlet fittings 226, 230 may be coupled to the housing 210 of the cartridge 200. Depending on which mode the cartridge 200 is in, fluid may exit through one (or both) of the outlet fittings 226, 230.
  • the second outlet fitting 230 may be in direct fluid communication with the fluid reservoir 220. This ensures that a suction path between the inlet 222 and the second outlet fitting 230 may remain open and independent from other functions of the cartridge 200 as described below.
  • the cartridge 200 may include a first conduit seat 260 and a second conduit seat 261 arranged so that the first and second actuators 160, 161 urge the first and second conduits 244, 245 against the first and second conduit seats 260, 261, respectively.
  • the conduit seats 260, 261 may increase the efficacy of the actuators 160, 161 in pinching the conduits 244, 245 closed and preventing fluid from flowing therethrough.
  • the conduit seats 260, 261 may project from the third sidewall 216 (i.e., the internal barrier) towards the second sidewall 216 and be shaped to have an arcuate face as shown in the figures. Other shapes are contemplated.
  • the first actuator 160 is shown actuated toward the first conduit seat 260 so that fluid cannot flow between the conduit junction 242 and the first conduit
  • the first actuator 160 is shown spaced apart from the first conduit seat 260 so that fluid may flow between the conduit junction 242 and the first conduit 244.
  • the second actuator 161 is shown actuated toward the second conduit seat 261 so that fluid cannot flow between the conduit junction 242 and the second conduit 245.
  • the first actuator 160 has been actuated toward the first conduit 244 so that fluid cannot flow between the conduit junction 242 and the first conduit 244.
  • the second actuator 161 is spaced apart away from the second conduit 245 so that fluid may flow between the conduit junction 242 and the second conduit 245.
  • the cartridge 200 is in the recirculation mode like the cartridge 200 of FIG. 6.
  • fluid is drawn from the fluid reservoir 220, through the detection block 250, through the third conduit 246, through the second conduit 245, and back into the fluid reservoir 220.
  • the fluid is drawn into the cartridge 200 through the inlet fitting 222 via the vacuum source 30 and/or the peristaltic pump 114 acting on the third conduit 246.
  • the fluid flows into the fluid reservoir 220.
  • the cartridge 200 may include a curved wall 227 arranged near’ the inlet fitting 222 and within the fluid reservoir 220.
  • the curved wall 227 is meant to decrease the velocity of the fluid flowing into the inlet fitting 222 in order to reduce the amount of foam generated within the fluid reservoir 220.
  • reducing the amount of foam introduced into the cartridge 200 also reduces the potential for false fluid level readings by the fluid level sensors 270.
  • the second weir 267 includes a second valve feature 279 that is connected to the deformable portion 269 of the second weir 267.
  • the second valve feature 279 can be urged into a first hole 223 of the first conduit 244 to control fluid communication between the first conduit 244 and the outlet 226.
  • fluid communication between the first conduit 244 and the outlet 226 is allowed when the second weir 267 is unpressed, and this fluid communication is interrupted when the second weir 267 is depressed.
  • the cartridge 200 is in the recirculation mode when the first weir 264 is unpressed while the second weir 267 is depressed, and in the purge mode when the first weir 264 is depressed while the second weir 267 is unpressed.
  • FIG. 17A the cartridge 200 is shown operating in the fill mode.
  • the first weir 264 is unpressed and the second weir 267 is depressed when the cartridge 200 is in the fill mode.
  • fluid and air
  • the weirs 264, 267 being in the aforementioned positions, air within the fluid reservoir 220 can be drawn into the second conduit 245 through the first weir 264 while fluid may be prevented from entering the detection block 250 (or at least not urged into and through the detection block 250) because the second weir 267 is depressed and blocking fluid passage through the first and third conduits 244, 246.
  • FIG. 17B the cartridge 200 is shown operating in the purge mode.
  • the first weir 264 is depressed and the second weir 267 is unpressed when the cartridge 200 is in the purge mode.
  • fluid is drawn into the fluid reservoir 220 through the inlet 222. Since the first weir 264 is depressed and the second weir 267 is unpressed, fluid within the reservoir 220 is draw along a second flow path P2 such that the fluid flows through the detection block 250, through the third conduit 246, through the first conduit 244, past the second weir 267, through the fourth conduit 248, and out of the outlet 226.
  • the depressed first weir 264 blocks air/fluid from entering the second conduit 245.
  • the sensor assembly 120 may be used to detect characteristics of the fluid flowing through the block 250 like in other implementations. Unlike other implementations, however, the controller 42 does not rely on characteristics of the peristaltic pump 114 to estimate a volume of fluid drawn out of the cartridge 200 since the peristaltic pump 114 is not used for this implementation. Instead, the cartridge 200 of FIGS. 16-17B may include a flow sensor 126 (e.g., an ultrasonic flow sensor) coupled to the housing 210 and configured to estimate a volume of fluid being drawn out of the cartridge 200 during the purge mode. In the figures, the flow sensor 126 is operably coupled to the third conduit 246 and estimates the volume of fluid flowing through the third conduit 246.
  • a flow sensor 126 e.g., an ultrasonic flow sensor
  • the console 100 may include the flow sensor 126 arranged within the shell in a way that causes the flow sensor 126 to abut or be near the third conduit 246 (or other conduit 244, 245, 248) when the cartridge 200 is received within the receiver 110.
  • fluid levels sensor(s) may detect a fluid level within the fluid reservoir 220 and send signals to the controller 42 to switch the cartridge 200 into the purge mode when the fluid level within the fluid reservoir 220 reaches a predetermined fluid level.
  • the cartridge 200 may be switched into the purge mode when the fluid level sensors detect that the fluid reservoir 220 is filled to or exceeding 50% capacity.
  • the cartridge 200 may be switched into the fill mode when the fluid level sensors detect that the fluid level within the fluid reservoir 220 is below a predetermined fluid level.
  • the cartridge 200 may be switched into the fill mode when the fluid level sensors detect that the fluid reservoir 220 is below 20% capacity.
  • FIG. 18 another implementation of the cartridge 200 is shown.
  • the cartridge 200 has been modified to removably attach onto a canister 310 as a lid.
  • the canister 310 acts as the first sidewall 212 of the cartridge 200 and defines the fluid reservoir 220 between walls 312 of the canister 310 and the second sidewall 214 of the cartridge 200.
  • the rest of the components of the cartridge 200 are contained within the compartment 218 defined between the second and third side walls 214, 216 similar to other implementations (e.g., those shown in FIGS. 4-11).
  • the cartridge 200 may be detached from the canister 310, a secondary compartment element (not shown) may be coupled to the second sidewall 214 of the cartridge 200, and the cartridge 200 may then be inserted within the cartridge receiver 110.
  • the secondary compartment element and second sidewall 214 may be define the fluid reservoir 220, similar to how the first and second sidewalls 212, 214 define the fluid reservoir 220 in other implementations.
  • the cartridge 200 may be designed to be used a limited number of times, after which at least a portion of the cartridge 200 must be replaced.
  • the cartridge 200 may include a radiofrequency identification tag coupled to the housing (not shown) which may be read by the console 100 or another suitable device.
  • the tag may contain usage data, such as a permitted number of uses of the cartridge 200.
  • the detection block 250 may include its own radiofrequency identification tag containing similar information that may be read by the console 100 or other device.
  • the cartridge 200 is designed to be used 10 times, while the detection block 250 is meant to be used once.
  • the console 100 may be configured to authenticate the cartridge 200 and/or detection block 250 to be used.
  • a method 400 of controlling use of the cartridge 200 is shown.
  • the method 400 may be earned out by the controller 42 or other computing device, and various prompts included in the method 400 may be presented on the display 52, 53 or other display device. That said, the method 400 is described herein as being carried out by the controller 42 and with the display 52 for brevity and clarity.
  • the method 400 begins when the user indicates that the current use of the cartridge 200 has completed, such as by pressing an end procedure button on the display 52. Once the controller 42 determines that the current use of the cartridge 200 is complete, the method 400 continues to step 408.
  • the controller 42 determines a number of times that the cartridge 200 has been used (i.e., a number of uses corresponding to the cartridge 200), such as by reading the tag coupled to the cartridge 200. The controller 42 then compares the number of uses to a predetermined number, such as a permitted number of uses of the cartridge 200, to determine if the number of uses has reached the predetermined number. If so, the method 400 continues to step 410. At step 410, a notification is triggered to inform the user that the cartridge 200 has reached the reuse limit, such as by providing the notification on the display 52 informing the user that the cartridge 200 cannot be sufficiently cleaned for reuse due to the number of uses exceeding the predetermined number.
  • step 448 the user is prompted to remove the cartridge 200 from the console 100 and dispose of the cartridge 200.
  • the prompt may also suggest or require disposing of the tubing 36 and/or the filter(s) 350.
  • the method 400 then concludes after step 448.
  • step 412 if the number of uses associated with the cartridge 200 is below the predetermined number.
  • the controller 42 asks the user if reusing the cartridge 200 is desired, such as by causing the display 52 to show a yes/no option which accepts user input. If not, the method continues to step 448. If the user does want to reuse the cartridge 200, however, the method 400 continues to step 416. Overall, steps 416 through 444 represent a cleaning process.
  • the controller 42 prompts the user to suction cleaning fluid into the cartridge 200 and then proceeds to step 420.
  • the method 400 determines if the fluid level within the fluid reservoir 220 has reached a predetermined fluid level using the fluid level sensor(s) 270. If not, the method 400 loops back to step 416. Once the fluid level reaches the predetermined fluid level, the method continues to step 424. [0096] At step 424, the controller 42 causes the console 100 to switch the cartridge 200 into the purge mode so that fluid begins leaving the fluid reservoir 220. At step 428, the fluid being purged from the cartridge 200 passes through the detection block 250 and is analyzed by the console 100 (e.g., by the sensor assembly 120). The method then continues to step 432.
  • the controller 42 determines the characteristics of the fluid flowing through the detection block 250 in order to determine if the fluid indicates that the cartridge 200 is adequately clean. If not, the method 400 moves to step 436, at which point an iteration counter may be incremented. The method continues to step 440 after step 436, and the counter is compared to an iteration threshold to determine if the cleaning cycle (i.e. , steps 416 to 444) should be repeated. More specifically, the method 400 may be configured to cause the cartridge 200 to be cleaned/rinsed with cleaning fluid a set number of times.
  • the controller 42 may assume that the cartridge 200 is not able to be sufficiently cleaned and should instead be disposed of (or a portion of the cartridge 200 should be disposed of). Thus, based on the comparison at step 440, the method 400 either continues to step 444 or loops back to step 416. If the method 400 has looped repeatedly such that the iteration counter is higher than the threshold, the method 400 moves to step 444. At step 444, the controller 42 triggers a notification to inform the user that the cartridge 200 is considered soiled and cannot be reused, such as causing the display 52 to show a pop-up notification. After the notification is triggered, the method continues to step 448.
  • step 432 the controller 42 determines that the fluid characteristics indicate that the cartridge 200 is adequately clean, the method 400 continues to step 434.
  • the controller 42 prompts the user to remove and/or dispose of single-use features of, or used with, the cartridge 200, such as the suction tubing 36 and/or the detection block 250.
  • the cartridge 200 is designed to be used with the external filter 350 which is meant to be disposed of after every use of the cartridge 200.
  • the controller 42 may instruct the user to remove/dispose of the external filter 350 along with the tubing 36.
  • the controller 42 may cause the display 52, 53 to show that the cartridge 200 is sufficiently clean based on step 432 and/or indicate on the display 52, 53 that the tubing 36 should be replaced with a replacement tubing.
  • the controller 42 may also cause the display 52, 53 to indicate that the detection block 250 should be replaced with a replacement detection block.
  • the cartridge 200 may include fluid level sensors 270 in communication with the controller 42, such as for the purpose of determining in which operating mode the cartridge 200 should be operating.
  • the console 100 may include the fluid level sensors 270 instead of the cartridge 200 including the level sensors 270.
  • the fluid level sensors 270 may be in electrical communication with the controller 42 in this implementation. This can help lower the complexity and cost of the cartridge 200.
  • the console 100 may include the fluid level sensors 270 within and/or adjacent to the cartridge receiver 110 such that the level sensors 270 are positioned adjacent to the first sidewall 212 and fluid reservoir 220 of the cartridge 200 when the cartridge 200 is seated within the cartridge receiver 110.
  • the fluid level sensors 270 may be capacitive sensors which capacitively detect the fluid level within the fluid reservoir 220 through the first sidewall 212.
  • the cartridge 200 may include at least one fluid level sensor 270 coupled to the first sidewall 212 of the housing 210.
  • the cartridge 200 includes a first fluid level sensor 272, a second fluid level sensor 274, and a third fluid level sensor 276, each being disposed on the first sidewall 212.
  • the first fluid level sensor 272 may be disposed near a middle thereof.
  • the second sensor 274 may be disposed between the first sensor 272 and the base 211, and the third sensor 276 may be disposed between the first sensor 272 and the top 217.
  • Each of the fluid level sensor(s) 270 may be a resistive sensor, a capacitive sensor, a conductive strip, or any suitable alternative.
  • the fluid level sensor(s) 270 may be in communication with the controller 42 such that signals can be transmitted by the fluid level sensor(s) 270 to the controller 42.
  • the cartridge 200 may include an electronic connector coupled to the housing and configured to mate with another electronic connector coupled to the console 100 and in communication with the controller 42 such that fluid level sensor(s) 270 may send signals to and receive signals from the console 100.
  • the fluid level scnsor(s) 270 may continuously detect the fluid level within the fluid reservoir 220. Alternatively, the sensor(s) 270 may periodically detect the fluid level at certain intervals or according to specific triggers.
  • the controller 42 may know how full the fluid reservoir 220 of the cartridge 200 is at any given time. For example, if the first fluid level sensor 272 detects fluid, the fluid reservoir 220 may be considered to be at least half full. If the second fluid level sensor 274 detects fluid, but the other fluid level sensors 272, 276 do not detect fluid, the fluid reservoir 220 may be considered to be less than half full but not empty. If the third fluid level sensor 276 detects fluid, the fluid reservoir 220 may be considered to be at least mostly full. Based on the signals from the fluid level sensor(s) 270, the controller 42 may change the cartridge 200 between modes operation as described with reference to FIGS. 7-8 and 11-12 above.
  • the fluid suctioned from the surgical site and into the cartridge 200 can become aerated as blood mixes with air during transport through the suction line.
  • This aeration, as well as a high flow rate generated by the vacuum source 30, can generate significant quantities of foam within the fluid reservoir 220.
  • This foam can act on the fluid level sensor(s) 270 (e.g., capacitive sensors) in the same way as fluid, which creates false level detection signals.
  • antifoaming chemical agents exist, using these agents to reduce the foam within the cartridge 200 would add additional levels of complexity and cost to the system and may interfere with the accurate measurement of blood concentration if the chemical agents change the optical properties of the blood.
  • FIGS. 21-24 illustrate various optional features of the cartridge 200 that may help avoid false level detection and reduce cost of the cartridge 200.
  • the cartridge 200 includes a series of protrusions 215 extending from the first side wall 212 and into the fluid reservoir 220 that are configured to minimize bubbles/foam within the liquid medical waste (see also FIG. 23).
  • the protrusions 215 may be arranged near the fluid level sensors 270 to prevent bubbles/foam from forming on and/or near the fluid level sensors 270 and improve the accuracy of the fluid level readings by the fluid level sensor(s) 270.
  • the protrusions 215 may be implemented as different shapes, such as spikes or other suitable shapes.
  • the protrusions 215 may extend all the way from the first sidewall 212 to the second/third sidewall 214, 216 (depending on which sidewalls 212, 214, 216 define the fluid reservoir 220 in the implementation of the cartridge 200) so as to extend across the entirety of the fluid reservoir 220.
  • the protrusions 215 may act as stiffening members that prevent the sidewalls 212, 214, 216 from flexing inward as suction is drawn on the cartridge 200.
  • the cartridge 200 may include a foam shield 290 within the fluid reservoir 220 and arranged such that fluid within the shield 290 is aligned with the fluid level sensors 270 of the console 100 when the cartridge 200 is seated within the cartridge receiver 110.
  • the foam shield 290 is meant to reduce the amount of foam that can be present near the fluid level sensors 270.
  • the foam shield 290 includes an upper outer barrier 291, an upper inner barrier 292, a lower barrier 293, a first side barrier 294, and a second side barrier 295.
  • Each of the barriers 291, 292, 293, 294, 295 may be protrusions extending from one side of the fluid reservoir 220 to the other, such as between the first sidewall 212 and the second or third sidewall 214, 216.
  • the second side barrier 295 is positioned closer to the front of the housing 210 (z.e., closer to the inlet 222) than the rest of the banders 291, 292, 293, 294, while the first side bander 294 is positioned closer to a rear of the housing (z.e., furthest from the inlet 222) that the remaining banders 291, 292, 293, 295.
  • the channel 296 includes a channel inlet 298 and a channel outlet 299.
  • the channel inlet 298 may be vertically aligned with the lower inlet opening 297 and/or horizontally aligned in elevation with the channel outlet 299.
  • the channel 296 may be sloped upwards, like the v-shaped channel of the illustrated implementation, to require the fluid to be drawn up the slope when traversing the channel 296.
  • the channel 296 Requiring the fluid to be drawn up the slope when traversing the channel 296 delays the foam from entering the foam shield 290 when the fluid level within the fluid reservoir 220 changes. It is also contemplated to form the channel 296 as a downward facing parabola or other shape. That said, so long as the channel outlet 299 is lower than the highest point of the channel 296, the amount of foam drawn into the foam shield 290 is reduced because the fluid level must reach a lower level before the foam on top of the fluid reaches the outlet 299.
  • the lower inlet opening 297 may be positioned closest to the front of the housing 210 compared to the rest of the openings 298, 299, and the channel outlet opening 299 may be positioned closest to the rear of the housing 210 compared to the other openings 297, 298.
  • the inner upper barrier 292, the lower barrier 293, and the side barriers 294, 295 together define a void 300 in fluid communication with the channel inlet 298 and the lower inlet opening 297.
  • the void 300 is pentagonal, but other shapes are contemplated.
  • FIGS. 22A-22F The functionality of the foam shield 290 is shown in FIGS. 22A-22F.
  • fluid begins entering the void 300 via the lower inlet opening 297 as the fluid level rises within the fluid reservoir 220.
  • Air AR present within the void 300 prior to filling is pushed into the channel 296 through the channel inlet 298, and out through the channel 296 through the channel outlet 299.
  • the lower inlet opening 297 may be designed as a small opening so that foam can only enter the void 300 at the staid of the fill and is minimized once the fluid level reaches the lower inlet opening 297.
  • the lower barrier 293 may also be angled relative to the remainder of the housing 210 (i.e., ramped) to decrease the tendency for foam to enter the void 300 due to the higher viscosity of blood compared to foam.
  • the channel 296 may include features to cause bubbles included in the foam to expand and burst while traversing the channel 296. As shown in FIG. 22B, fluid continues filling of the void 300 until the fluid level meets the channel inlet 298, at which point some remaining air AR is trapped near a top of the void 300. By trapping the air AR near the top of the void 300, surface tension between the fluid and the top of the void 300 is reduced or avoided, and fluid may more easily leave the void 300 through the inlet 297.
  • FIGS. 22C-22F depict decreasing fluid levels within the fluid reservoir 220.
  • foam FO is drawn into the channel outlet 299 as the fluid level drops below the channel 296. More specifically, when the fluid level drops during purge mode, the fluid FL passes below the channel outlet 299 and any foam FO present on the surface of the fluid FL may be pulled into the channel 296 as the foam shield 290 begins to empty through the lower inlet opening 297. Some fluid FL may also be drawn into the foam shield 290 at the same time.
  • the fluid level within the void 300 is stabilized by the design of the foam shield 290 and is delayed from leaving the void 300 until the fluid level outside of the foam shield 290 reaches a predetermined fluid level.
  • air AR and foam FO replaces the fluid FL within the void 300 (see FIG. 22E) as the fluid level decreases, and air AR replace the foam FO (see FIG. 22F), as the fluid level decreases further. Since most of the foam passes over the foam shield 290 rather than being drawn into the void 300, the amount of foam that may end up in fornt of the fluid level sensor 270 is reduced, and false fluid level readings are minimised. Any foam that remains in the channel after emptying will then be pushed out on the next fill cycle (i.e., once the cartridge 200 has been moved back into recirculation mode).
  • the cartridge 200 may include multiple foam shields 290, similar to how the cartridge 200 implementation shown in FIG. 20 includes three fluid level sensors 270.
  • the plurality of foam shields 290 may be disposed at various positions relative to the height of the cartridge. This way, for example, a first capacitive sensor of the console 100 can determine whether fluid is disposed within a first foam shield which is disposed near the middle of the first sidewall 212. Continuing the example, second and third capacitive sensors can determine whether fluid is within a second and third foam shield, respectively.
  • the second foam shield can be disposed between the first foam shield and the base 211, while the third foam shield can be disposed between the first foam shield and the top 217.
  • fluid within the second foam shield may indicate that the fluid reservoir 220 is at least partially filled with fluid (e.g., filled to at least 30% capacity)
  • fluid within the first foam shield may indicate that the reservoir 220 is at least half filled with fluid
  • fluid within the third foam shield may indicate that the reservoir 220 is mostly filled with fluid (e.g., filled to at least 70% capacity).
  • the fluid level measurements may be more reliable for the reasons described above with respect to the foam shield 290.
  • the cartridge 200 includes a float assembly 280 disposed within the fluid reservoir 220.
  • the float assembly 280 may include a float casing 281, a pivot 282 pivotably coupling the float casing 281 to the housing 210, and a recess 283 defined by the float casing 281 and configured to receive a magnetic element (not shown).
  • the float casing 281 is designed to be buoyant and rotate about the pivot 282 as the fluid level within the reservoir 220 increases.
  • the float casing 281 may include a first lateral sidewall 284 and a second lateral sidewall 285 which arc planar, oriented parallel to one another 284, 285, and separated by an endwall 286.
  • the first lateral sidewall 284 may be positioned adjacent the first sidewall 212 (not shown in FIG. 23) and define the recess 283 which is configured to receive and retain the magnetic element, such as via a press fit arrangement.
  • the endwall 286 may include an arcuate portion and two flat portions.
  • the walls 284, 285, 286 may together define a hollow space (not shown) within the casing 281.
  • the float assembly 280 is configured to rotate about the pivot 282 as the fluid level within the reservoir 220 increases.
  • the magnetic element within the recess 283 travels in a sweeping/arcuate motion.
  • the fluid level sensors 270 may be electromagnetic sensors, such as reed switches, configured to sense the presence of the magnetic element.
  • the console 100 may include the first fluid level sensor 272 and the second fluid level sensor 274, each implemented as reed switches.
  • the cartridge 200 may include the level sensors 270, 272, 274 coupled to the housing 210. In either case, the magnetic element rises as the float assembly 280 rotates, and the fluid level can be determined based on which of the first/second sensors 272, 274 detect the magnetic element.
  • the float assembly 280 may include additional features to increase the efficacy of the float assembly 280 in determining fluid level within the fluid reservoir 220.
  • the float assembly 280 may include protrusions extending outwardly from the float casing 281 and configured to break surface tension of the fluid within the reservoir 220. More specifically, a suction force may form between the housing 210 and the lateral sidewalls 284, 285 when fluid is present between the two 210, 284/285 due to the surface tension of the fluid.
  • the protrusions may include elongate ridge(s) 287 extending outwardly from at least one of the first lateral sidewall 284 and the second lateral sidewall 285, and/or conical/dome- shaped geometries 288 extending outwardly from the endwall 286.
  • the elongate ridges 287 may be arcuate in a direction of a sweeping motion of the float casing 281 about the pivot 282.
  • the ridges 287 may be shaped as portions of concentric circles that are centered on the pivot 282 but have different radii.
  • these protrusions prevent the cndwall 286 from sticking to the other portions of the housing 210 (e.g., the base 211) by breaking the surface tension of fluid between the housing 210 and the endwall 286.
  • Both elements 287, 288 increase the accuracy of fluid level detection using the float assembly 280.
  • the float assembly 280 may provide a lower-than-actual fluid level if the flat portion of the endwall 286 were to stick to the bottom of the cartridge 200.
  • the float assembly 280 may provide a higher-than actual fluid level if the arcuate portion of the endwall 286 sticks to the side of the cartridge 200.
  • the sensor assembly 120 is shown without the rest of the console 100.
  • the sensor assembly 120 includes an upper sensor bracket 130 and a lower sensor bracket 140.
  • These upper and lower sensor brackets 130, 140 are arranged relative to one another such that the detection block 250 of the cartridge 200 rests between the sensor brackets 130, 140 when the cartridge 200 is seated within the cartridge receiver 110 of the console 100.
  • the upper sensor bracket 130 includes an upper mount 132 mounted within the cartridge receiver 110 and an upper sensor head 134 movably coupled to the upper mount 132.
  • the lower sensor bracket 140 includes a lower mount 142 mounted within the cartridge receiver 110 and a lower sensor head 144 movably coupled to the lower mount 142.
  • the upper sensor head 134 may include the optical emitter 122 and the lower sensor head 144 may include the optical detector 124 as shown in FIG. 25. In other implementations, the upper sensor head 134 may include the optical detector 124 and the lower sensor head 144 may include the optical emitter 122. In further implementations, the sensor heads 134, 144 may each include the optical emitter 122 and the optical detector 124 such that there are two emitter-detector pairs, one emitter 122 transmitting light from the upper sensor head 134 to the lower sensor head 144, and the other emitter 122 transmitting light from the lower sensor head 144 to the upper sensor 134. Regardless of implementation, light is transmitted from the optical emitter(s) 122, through one detection window 254 of the detection block 250, through the fluid flowing along the fluid channel 252, out through the other detection window(s) 254, and to the optical detector(s) 124.
  • the sensor assembly 120 may also include a lateral sensor bracket 150 which has a lateral mount 152 mounted within the cartridge receiver and a lateral sensor head 154 movably coupled to the lateral mount 152.
  • the lateral sensor head 154 is arranged such that the emitter(s) 122, 124 disposed therein line up with the detection window 254 of the detection block 250 when the cartridge 200 is within the cartridge receiver 110 of the console 100.
  • the lateral sensor head 154 includes the optical detector 124.
  • one of the upper or lower sensor heads 134, 144 may also include the optical detector.
  • the upper sensor head 144 may include the optical emitter 122, while the lower and lateral sensor heads 134, 154 each include respective optical detectors 124.
  • the optical detector 124 of the lower sensor head 134 may receive a light signal which corresponds to the light emitted by the optical emitter 122 as attenuated by the fluid disposed between the detection windows 254.
  • the optical detector 124 of the lateral sensor head 154 may receive a scattered light signal which corresponds to the light emitted by the optical emitter 122 as scattered by the fluid disposed between the detection windows 254.
  • the detection block 250 may have a thickness, as defined by the distance between the upper and lower surfaces 257, 258, which largely matches the distance between the upper and lower sensor brackets 130, 140.
  • the detection block may have a thickness of 1.0 centimeters. That being said, in order to ensure that the sensor assembly 120 is able to accurately characterize the fluid flowing through the fluid channel 252 of the detection block 250, at least one of the sensor brackets 130, 140, 150 may be biased towards the respective surface 257, 258, 259 of the detection block 250. To that end, as shown in FIG. 26, the sensor assembly 120 may include at least one biasing member 170 disposed near the sensor bracket(s) 130, 140, 150.
  • the sensor assembly 120 may include at least one of an upper sensor biasing member 171 disposed between the upper mount 132 and the upper sensor head 134, a lower biasing member 172 disposed between the lower mount 142 and the lower sensor head 144, and/or a lateral biasing member 173 disposed between the lateral mount 152 and the lateral sensor head 154.
  • the biasing member(s) 171, 172, 173 are configured to bias the respective sensor head 134, 144, 154 away from the respective mount 132, 142, 152 and toward the detection block 250.
  • the upper biasing member 171 may bias the upper sensor head 134 into direct contact with the upper surface 257 of the detection block 250 such that optical signals sent to/from the upper sensor head 134 need not travel far between the detection window 254 of the upper surface 257 and the optical emitter-detector 122, 124 disposed within the upper sensor head 134.
  • the lower biasing member 172 may bias the lower sensor head 144 into direct contact with the lower surface 258 of the detection block 250 such that optical signals sent to/from the lower sensor head 144 need not travel far between the detection window 254 of the lower surface 258 and the optical emitter-detector 122, 124 disposed within the lower sensor head 144.
  • the lateral biasing member 173 may bias the lateral sensor head 154 into direct contact with the lateral surface 259 of the detection block 250 such that optical signals sent to/from the lateral sensor head 154 need not travel far between the detection window 254 of the lateral surface 259 and the optical emitter/detector 122, 124 disposed within the lateral sensor head 154.
  • the biasing members 171, 172 may be configured to bias the sensor heads 134, 144 in multiple degrees of freedom.
  • the biasing member 171 may provide a translational biasing force which urges the sensor heads 134, 144 towards the respective detection windows 254, as well as a rotational biasing force to accommodate any difference in rotation between the biasing member 171, 172 and the sensor head 134, 144.
  • the biasing members 171, 172 include at least one of a collinear joint 175 which allows the biasing member to provide the translational biasing force and a revolute joint 176 which allows the biasing member 170 to provide the rotational biasing force.
  • the cartridge 200 is inserted into the cartridge receiver 110 of the console 100 before the method begins.
  • the method begins with drawing fluid through the inlet fitting 222, such as by the suction tool 40 or other vacuum source. Once fluid is drawn through the inlet fitting 222, the fluid drops into the fluid reservoir 220. With fluid now in the fluid reservoir 220, the peristaltic pump 114 is operated by the console 100 (e.g., activated by the controller 42) to draw the fluid from the fluid reservoir 220, and into the detection block 250 such that the fluid flows between the detection windows 254. As fluid flows between detection windows 254, the sensor assembly 120 is utilized by the system 20 e.g., by the controller 42) to detect a blood characteristic of the fluid, such as a concentration of blood in the fluid. Based on an analysis of the blood characteristic of the fluid, the eBL is determined.
  • a blood characteristic of the fluid such as a concentration of blood in the fluid.
  • the fluid may be analyzed by the sensor assembly 120 while the cartridge 200 is in any of the purge, recirculation, and fill modes.
  • the cartridge 200 may be set to the purge mode. In the purge mode, the fluid is drawn from the detection block 250, through the third conduit 246 (see FIGS. 7 and 11), through the first conduit 244, and finally out of the cartridge 200 via the first outlet fitting 226.
  • the cartridge 200 may be set to the recirculation mode. In the recirculation mode, the fluid is drawn from the detection block 250, through the third conduit 246 (see FIGS. 8 and 12), through the second conduit 245, and back into the fluid reservoir 220.
  • the cartridge 200 may be configured to switch between modes based on the needs of the user and/or characteristics of the fluid.
  • the method above may further include switching the operating mode of the cartridge 200.
  • the method may include changing from the recirculation mode to the purge mode.
  • the second actuator 161 may be actuated to close the second conduit 245 and prevent the fluid from flowing through the same.
  • the first actuator 160 may be actuated to open the first conduit 244 and permit the fluid to flow through the first conduit 244 and out of the cartridge 200 via the first outlet fitting 230.
  • the method may include changing from the purge mode to the recirculation mode.
  • the first actuator 160 may be actuated to close the first conduit 244 and prevent the fluid from flowing through the same.
  • the second actuator 161 may be actuated to open the second conduit 245 and permit the fluid to flow through the second conduit 245 and back into the fluid reservoir 220.
  • the method may include switching the cartridge 200 between the purge mode and the recirculation mode based on signals received from the fluid sensor(s) 270 as described above.
  • the method may include analyzing the fluid flowing within the detection block 250 only when the cartridge 200 is in the purge mode. This may be advantageous where an estimation of a volume of the fluid is desired or required.
  • the eBL may be calculated by determining a concentration of blood (or other characteristic) within the fluid by analyzing the fluid within the detection block 250.
  • the system 20 may determine a purged volume of fluid corresponding to the amount of fluid that has been expelled by the cartridge via the second outlet fitting 230. The volume of fluid can then be combined (e.g., multiplied) with the concentration of blood to estimate the blood loss. To that end, the volume of fluid may be determined in different ways.
  • the volume may be calculated based on the amount of fluid expelled from the cartridge 200 and into the waste container 26.
  • the camera e.g., a camera disposed within the cart 22 and/or external thereto
  • the volume may be calculated based on characteristics of the peristaltic pump 114, such as an average flow rate parameter of the peristaltic pump 114.
  • the average flow rate parameter (e.g., an average volumetric flow rate) may be multiplied by the amount of time that the peristaltic pump 114 has been active (e.g., number of rotations of the pump head) in order to determine the total volume of fluid that has been purged from the cartridge 200.
  • a flow sensor can be used to estimate the volumetric flow rate within the cartridge 200 or the total volume of fluid that has been purged from the cartridge 200.
  • the flow sensor may be an ultrasonic flow sensor, an optical flow sensor, or any suitable alternative. Further, the flow sensor may be coupled to any one of the conduits 244, 245, 246, or the fluid channel 252 of the detection block 250.
  • the optical flow sensor may be positioned adjacent to the detection window 254.
  • the optical flow sensor may be included in the sensor assembly 120 of the console 100.
  • the detection block 250 may include a second set of detection windows positioned about the channel 252, and the optical flow sensor may be positioned adjacent to the second set of detection windows.
  • the method may further include displaying details associated with the fluid passing through the cartridge 200 on the display 52, 53.
  • the method may include causing the display(s) 52, 53 to display at least one of: the eBL, the volumetric flow rate, the blood concentration, the operating mode of the cartridge 200, the volume of fluid within the waste container 26, and/or any other metric disclosed herein.
  • the method may include displaying a high fluid level warning on the display(s) 52, 53 based on signals from the fluid level sensor(s) 270.
  • the high fluid level warning may be triggered based on the third fluid level sensor 276 detecting a high fluid level.
  • FIG. 27A a graphed response curve correlating the detected optical signal to the estimated blood concentration is shown. At high concentrations (60%+), the response is relatively flat. In practice, this means that it is often too difficult to distinguish between, for example, 70% and 90% blood which makes the overall quantification of blood loss much less accurate. Since optical signals are measured to estimate concentration, it is advantageous if the optical signals, in both green and infrared channels, change as much as possible as concentration changes. To achieve this, an amplifier that can deal with a broad range of input voltages can be used.
  • the amplifier had the ability to distinguish between high concentration blood samples where there is little light passing through while also avoiding the case where the amplifier saturates and cannot measure low concentration blood samples meaningfully.
  • a logarithmic amplifier could be used to improve the accuracy of the measurement system.
  • FIGS. 27B and 28 an ideal response curve is illustrated along with an exemplary logarithmic amplifier which can be used to change the response curve from the curve shown in FIG. 27A into the curve shown in FIG. 27B.
  • Logarithmic amplifiers are typically used in audio and radar’ applications where the inputs and outputs range across several orders of magnitude (normally measured in decibels). The output of the logarithmic amplifier is proportional to the logarithm of the input, and the amplifier achieve this desired transfer function by using a non-linear component, often a diode, placed in the feedback loop of the amplifier (see FIG. 28).
  • the sensor assembly 120 includes a signal conditioning circuit to take advantage of the finding described in this section.
  • the signal conditioning circuit may be in electronic communication with the optical detector(s) 124 and may include a logarithmic amplifier and a non-inverting amplifier in series with one another. This way, the response (output) of the optical detector(s) 124 can be conditioned by the signal conditioning circuit (/. ⁇ ?.. by the logarithmic amplifier and the noninverting amplifier) to increase the accuracy of the sensor assembly 120 in determining characteristics of the fluid, such as the blood concentration of the fluid.
  • the signal conditioning circuit may include the logarithmic amplifier in series with an inverting amplifier.
  • the methods disclosed herein may be performed on a waste container that is not disposed on a mobile cart.
  • the methods may be used to estimate a concentration and an amount of a non-blood component within the waste container 26, such as saline, ascites, bile, irrigating fluids, saliva, gastric fluid, mucus, pleural fluid, interstitial fluid, urine, fecal matter, or the like.
  • the medical waste collection system 20 may communicate with other systems to form a fluid management ecosystem for generating a substantially comprehensive estimate of extracorporeal blood volume, total blood loss, patient euvolemia status, or the like.
  • a cartridge for estimating blood loss within liquid medical waste comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; an outlet fitting coupled to the housing and configured to be removably coupled with an outlet suction tube; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; and conduits disposed within or formed with the housing, wherein flow paths defined by the conduits are configured to be selectively controlled to provide for (i) a recirculation mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, and into the fluid reservoir, and (ii) a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, and
  • Clause 4 The cartridge of clause 2 or 3, wherein the cartridge is configured to be in the fill mode when the first weir is not actuated and the second weir is actuated, and wherein the second weir blocks fluid flow between the first conduit and the fourth conduit when depressed.
  • Clause 7 The cartridge of any one of clauses 2-6, further comprising a flow sensor coupled to the third conduit and configured to estimate a flow rate of liquid medical waste flowing within the third conduit.
  • Clause 13 The method of clause 12, further comprising further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed through the conduit assembly and into the fluid reservoir.
  • Clause 14 The method of clause 13, further comprising moving the cartridge from the purge mode to the recirculation mode by: actuating the first actuator to prevent flow of the liquid medical waste through a first conduit of the conduit assembly; and actuating the second actuator to permit the flow of the liquid medical waste through a second conduit of the conduit assembly and into the fluid reservoir.
  • Clause 16 The method of clause 14 or 15, wherein the first and second actuators are first and second pistons, wherein the step of actuating the first actuator further comprises moving the first piston to pinch or release an exposed portions of the first conduit, and wherein the step of actuating the second actuator further comprises moving the second piston to pinch or release an exposed portions of the second conduit.
  • Clause 17 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump to draw liquid medical waste from the fluid reservoir and through the detection window; detecting, with the sensor assembly, a blood characteristic of the liquid medical waste within or passing through the detection window; further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed through the conduit assembly and into the fluid reservoir; and not providing an output of analysis of the blood characteristic of the liquid medical waste with the cartridge in the recirculation mode.
  • Clause 18 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump to draw the liquid medical waste from the fluid reservoir and through the sensor assembly and detection window; detecting, with the sensor assembly, a blood characteristic of the liquid medical waste within or passing through the detection window; and further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and into the fluid reservoir without providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the recirculation mode.
  • Clause 19 The method of clause 18, further comprising analyzing homogeneity of the blood characteristic of the liquid medical waste with the cartridge in the recirculation mode.
  • Clause 20 The method of clause 19, further comprising moving the cartridge from the recirculation mode to a purge mode if the homogeneity is above a predetermined threshold.
  • Clause 21 The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
  • Clause 22 The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
  • Clause 23 The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
  • Clause 24 The method of any one of clauses 18-24, further comprising determining a purged volume of the liquid medical waste purged from the cartridge in the purge mode, wherein the step of estimating the blood loss is based on the blood characteristic and the purged volume.
  • Clause 25 The method of clause 25, wherein the step of determining the purged volume is based on the blood characteristics and operation of the peristaltic pump.
  • Clause 26 The method of clause 25, wherein the step of determining the purged volume is based on an external volume determination means.
  • Clause 27 The method of any one of clauses 18-25, wherein the cartridge includes at least one fluid level sensor, the method further comprising moving the cartridge between the purge mode and the recirculation mode based on a signal received from the at least one fluid level sensor.
  • Clause 29 The method of clause 28, wherein the cartridge further includes a second fluid level sensor positioned near a base of the cartridge, the method further comprising moving, with the controller, the cartridge from the purge mode to the recirculation based on the second fluid level sensor detecting a low fluid level.
  • Clause 30 The method of clause 29, wherein the cartridge further includes a third fluid level sensor positioned near a top of the cartridge, the method further comprising displaying, on a display of the console, a high fluid level warning based on the third fluid level sensor detecting a high fluid level.
  • a cartridge configured to be inserted into a console for estimating blood loss within liquid medical waste, wherein the console includes a sensor assembly, first and second actuators, a peristaltic pump, and a controller, the cartridge comprising: a housing defining a fluid reservoir; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; a first outlet fitting coupled to the housing and configured to be removably coupled with a first outlet suction tube; a conduit assembly; and at least one fluid level sensor, the at least one fluid level sensor including at least one fluid level sensor coupled to the housing and disposed within the fluid reservoir, wherein the at least one fluid level sensor is configured to be
  • Clause 34 The cartridge of clause 33, further comprising a protrusion positioned adjacent each of the at least one fluid level sensor, wherein the protrusions are configured to minimize bubbles within the liquid medical waste; and, optionally, wherein the protrusions are spikes.
  • Clause 35 The cartridge of clause 33 or 34, wherein the at least one fluid level sensor is one of a resistive sensor and a capacitive sensor.
  • Clause 36 The cartridge of clause 35, wherein the at least one fluid level sensor comprises a conductive strip.
  • a cartridge configured to be inserted into a console for quantifying blood within liquid medical waste, wherein the console includes a capacitive sensor, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a void space configured to be aligned with the capacitive sensor of the console, wherein the barriers comprise an upper inner banner and an upper outer barrier defining a channel therebetween, and a lower barrier defining a lower inlet opening, wherein the channel is configured to permit egress of air or foam with the liquid medical waste entering the void space through the lower inlet opening.
  • Clause 40 The cartridge of any one of clauses 37-39, wherein the inner upper barrier is ramped.
  • Clause 42 The cartridge of any one of clauses 37-41, wherein the barriers further comprises a first side barrier extending between the outer upper barrier and the lower inlet opening.
  • Clause 43 The cartridge of any one of clauses 37-42, wherein the outer upper barrier defines a channel outlet opening positioned external to the void space.
  • Clause 44 The cartridge of any one of clauses 37-43, further comprising a second side barrier extending between the inner upper barrier and the lower barrier.
  • a cartridge configured to be inserted into a console for quantifying blood within liquid medical waste, wherein the console includes a capacitive sensor, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a void space configured to be aligned with the capacitive sensor of the console, wherein the barriers define a lower inlet opening between the fluid reservoir and the void space, a channel, a channel inlet opening, a channel outlet between the void space from the channel, and a channel outlet opening between the channel and the fluid reservoir.
  • Clause 46 The cartridge of clause 45, wherein the channel inlet opening is vertically aligned with the lower inlet opening.
  • Clause 47 - The cartridge of clause 45 or 46, wherein the channel outlet opening is horizontally aligned in elevation with the channel inlet opening.
  • Clause 48 The cartridge of any one of clauses 45-47, wherein the channel is disposed above the channel outlet opening such that air or foam with the liquid medical waste is drawn into the void space under influence of vacuum as the liquid medical waste is being drawn out of the void space through the lower inlet opening during purging of the cartridge.
  • Clause 49 The cartridge of any one of clauses 45-48, wherein the barriers comprise a lower barrier, an upper inner barrier, and an outer inner barrier.
  • Clause 51 The cartridge of clause 49 or 50, wherein the inner upper barrier is V-shaped, and wherein the outer upper barrier is V-shaped and contoured to the inner upper barrier.
  • Clause 52 The cartridge of any one of clauses 49-51, wherein the barriers further comprise: a first side barrier extending between the outer upper barrier and the lower inlet opening; and a second side barrier extending between the inner upper bander and the lower barrier.
  • Clause 53 The cartridge of any one of clauses 37-52, wherein the housing comprises a front wall, a rear’ wall, and the opposing sidewalls, wherein the inlet fitting and the outlet fitting extend from the front wall, and wherein the lower inlet opening is positioned closest to the front wall relative of the void space.
  • Clause 54 The cartridge of any one of clauses 37-53, wherein the void space is pentagonal.
  • the capacitive sensor is a first capacitive sensor
  • the console further includes a second capacitive sensor
  • the plurality of barriers is a first plurality of barriers
  • the void space is a first void space configured to be aligned with a first capacitive sensor of the console, wherein the first void space is defined at a first height relative to the fluid reservoir
  • the cartridge further comprises: a second plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a second void space configured to be aligned with a second capacitive sensor of the console, wherein the barriers define a lower inlet opening between the fluid reservoir and the second void space, a channel, a channel inlet opening, a channel outlet between the second void space from the channel, and a channel outlet opening between the channel and the fluid reservoir, wherein the second void space is defined at a second height relative to the fluid reservoir, the second
  • Clause 56 - A system comprising: the cartridge of any one of clauses 37-55, further comprising a detection window; a console comprising the capacitive sensor and a controller in electronic communication with the capacitive sensor, wherein the controller is configured to: cause the external vacuum source to draw the liquid medical waste into the fluid reservoir through the first suction tube and the inlet fitting; receive signals from the capacitive sensor; compare the signals against a predetermined threshold; and selectively actuate actuators of the console based on the signals exceeding a predetermined threshold, wherein the cartridge is moved from a recirculation mode to a purge mode in which the liquid medical waste is directed through the detection window and the outlet fitting and into the second suction tube.

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Abstract

A cartridge and a console for estimating blood loss within liquid medical waste. The cartridge includes a detection block coupled to a housing and in fluid communication with a fluid reservoir. Conduits are disposed within or formed by the housing, and the conduits or weirs are configured to interface with actuators of the console for the system to be operable in one of a recirculation mode, a purge mode, and a fill mode. The characteristics of the fluid may be detected within the detection block by a sensor assembly of the console in the recirculation mode and/or the purge mode. A volume of the fluid being purged may be measured in the purge mode based on operation of a peristaltic pump of the console. The cartridge or the console may include sensors, and a controller on the console may operate the system in the recirculation or purge modes based on a level of the liquid medical waste detected within the fluid reservoir. Methods of operating the console are also disclosed.

Description

CARTRIDGE, CONSOLE, AND METHODS FOR ESTIMATING BLOOD LOSS IN MEDICAL WASTE
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and all the benefits of United States Provisional Patent Application No. 63/719,379, filed on November 12, 2024, and United States Provisional Patent Application No. 63,613,122, filed on December 21, 2023, the entire contents of each which is hereby incorporated by reference.
BACKGROUND
[0002] Utilizing optical emitters and optical detectors to characterize properties of a fluid is established in the art. Known arrangements have included optical emitters that emit a predetermined wavelength of light based on absorption characteristics of a substance of interest, namely blood or hemoglobin. Based on the absorption and scatter of the emitted light as detected by the optical detectors, certain properties of the fluid may be characterized. One such system is disclosed in commonly-owned United States Patent Publication No. 2022/0008637, published January 13, 2022, the entire contents of which are hereby incorporated by reference, in which a sensor module is coupled to a conduit.
[0003] More recently, it has been contemplated to integrate the sensor module on a medical waste collection system including a vacuum source, a waste container, a fluid measuring assembly, and other subsystems. For example, commonly-owned International Patent Publication No. WO 2022/103912, published May 19, 2022, the entire contents being hereby incorporated by reference, discloses a cartridge removably couplable with a cartridge receiver to be operably positioned relative to the sensor module of the medical waste collection system. While the system realizes many benefits (e.g., continuous fluid volume calculations real-time for blood loss determinations), the arrangement requires appreciable design and modification of capital equipment.
[0004] Therefore, there is a need in the art for a system that realizes the benefits of optical-based fluid characterization to be operable with waste collection systems without modification thereof. It would be further desirable for the system to be modular and operable with most other legacy systems that include a vacuum source and a waste container, such as a hospital-integrated vacuum source, and the like. SUMMARY
[0005] The present disclosure is directed to cartridges, systems and methods for estimating blood loss within medical waste. In particular, implementations of the cartridge may define a fluid reservoir for the medical waste to be drawn into and collected therein, after which the liquid medical waste may buffer by permitting air to separate from the medical waste. An external vacuum may be used to draw the medical waste into the cartridge. The medical waste is further moved through conduits of the cartridge, for example, by a peristaltic pump of the console that is separate from the vacuum source. The medical waste is moved through a detection window for analysis from a sensor assembly of the console. The sensor assembly detects characteristics of the medical waste indicative of a concentration of a blood component within the medical waste, for example, hemoglobin. The flow rate or volume of the medical waste being drawn through the cartridge may be determined by a sensor associated with the cartridge or the console, for example, an ultrasonic sensor or monitoring operation of the peristaltic pump. The volume of the medical waste in combination of the blood component may be used to estimate the blood loss. This may be performed in an automated, semi-automated or manner, and/or in a continuous or intermittent manner.
[0006] Therefore, according to a first aspect, a cartridge for estimating blood loss within liquid medical waste with a console is disclosed. The cartridge includes a housing which defines a fluid reservoir. A detection block is coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir. The detection block also defines a detection window that is transparent for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console. The cartridge includes an inlet fitting in fluid communication with the fluid reservoir. The inlet fitting is configured to be removably coupled with an inlet suction tube, which is coupled to a suction instrument configured to be deployed at the surgical site. To facilitate fluid transfer out of the cartridge, the cartridge includes a first outlet fitting configured to be removably coupled with a first outlet suction tube operably coupled to an external vacuum source. The external source may be on a medical waste collection system, and a manifold may be insertable therein as a sterile barrier. The cartridge includes a conduit assembly. The conduit assembly includes first and second conduits disposed within or formed with the housing, and a third conduit coupled to the housing and configured to engage the peristaltic pump of the console to move the liquid medical waste from the fluid reservoir, through the detection block, and to cither (i) the first conduit to be recirculated or (ii) to the second conduit to be purged. In certain implementations, the conduit assembly includes a conduit junction. The first conduit provides fluid communication between the first outlet fitting and the conduit junction. The second conduit provides fluid communication between the conduit junction and the fluid reservoir. The third conduit provides fluid communication between the conduit junction and the detection block.
[0007] A second aspect of the disclosure is directed to the cartridge including the housing defining the fluid reservoir, the detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, the inlet fitting coupled in fluid communication with the fluid reservoir, and the first outlet fitting configured to be removably coupled with a first outlet suction tube. The first, second, and third conduits of the conduit assembly are configured to interface with the first and second actuators and the peristaltic pump of the console to selectively move the cartridge between a recirculation mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the second conduit, and into the fluid reservoir, and a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the first conduit, and through the first outlet fitting.
[0008] A third aspect of the disclosure is directed to the cartridge including the housing defining the fluid reservoir and a compartment separate from the fluid reservoir. The separation may be from an interior barrier of the housing. The detection block is coupled to the housing and defines a fluid channel in fluid communication with the fluid reservoir. The conduit assembly is disposed within the compartment and includes a first conduit and a second conduit The housing may defines a first lateral aperture exposing a portion of the first conduit and configured to be aligned with the first actuator of the console, and a second lateral aperture exposing a portion of the second conduit and configured to be aligned with the second actuator of the console.
[0009] According to a fourth aspect of the disclosure, the housing of the cartridge includes a base, an upper surface opposite the base, a front and opposing lateral sides extending between the base and the upper surface, and an interior barrier. The housing defines a fluid reservoir between one of the opposing lateral sides the interior barrier and a compartment between the other one of the opposing lateral sides and the interior barrier. The cartridge also includes the detection block extending from the compartment and defining a fluid channel in fluid communication with the fluid reservoir. The inlet fitting is coupled to the front of the housing and in fluid communication with the fluid reservoir that is configured to be removably coupled with an inlet suction tube, and a first outlet fitting is coupled to the front of the housing and configured to be removably coupled with a first outlet suction tube. The conduit assembly is disposed within the compartment.
[0010] A fifth aspect of the disclosure includes the console having a capacitive sensor. The house of the cartridge includes a plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a void space configured to be aligned with the capacitive sensor of the console. The inlet fitting is in fluid communication with the fluid reservoir and is configured to be removably coupled with a first suction tube. The outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source. The barriers include an upper inner barrier and an upper outer barrier defining a channel therebetween, and a lower barrier defining a lower inlet opening. The channel is configured to permit egress of air or foam with the liquid medical waste entering the void space through the lower inlet opening to avoid inaccurate readings of the capacitive sensor of the console.
[0011] A sixth aspect of the present disclosure includes the plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining the void space configured to be aligned with the capacitive sensor of the console. The barriers define a lower inlet opening between the fluid reservoir and the void space, a channel, a channel inlet opening, a channel outlet between the void space from the channel, and a channel outlet opening between the channel and the fluid reservoir.
[0012] According to a seventh aspect, the cartridge includes a float assembly disposed within the fluid reservoir. The float assembly includes a float casing, a pivot pivotably coupling the float casing to the housing, and a magnetic element coupled to the float casing. In certain implementations, the float assembly includes a float casing having lateral sidewalls slidably positioned between opposing interior surfaces of the housing, an endwall extending between the lateral sidewalls, and protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste. [0013] An eighth aspect of the present disclosure includes the conduit assembly having the first conduit, the second conduit, the third conduit, and a fourth conduit. The conduit assembly is configured to interface with the first and second actuators of the console to selectively move the cartridge between a fill mode in which air is drawn from the fluid reservoir, through the second conduit, through the fourth conduit, and through the outlet fitting, and fluid is drawn through the inlet fitting and into the fluid reservoir, and a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the first conduit, through the fourth conduit, and through the first outlet fitting.
[0014] According to a ninth aspect, a method of estimating blood loss includes operating the peristaltic pump to draw the liquid medical waste from the fluid reservoir and through the detection window. A blood characteristic of the liquid medical waste within or passing through the detection window is detected with the sensor assembly. The peristaltic pump is operated with the cartridge in a purge mode in which the liquid medical waste is directed through the conduit assembly and through the first outlet fitting. The blood loss is estimated based in part on an analysis of the blood characteristic of the liquid medical waste. In certain implementations, the method includes operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed through the conduit assembly and into the fluid reservoir, wherein an output of analysis of the blood characteristic of the liquid medical waste is not provided with the cartridge in the recirculation mode.
[0015] A tenth aspect of the present disclosure is directed to a method in which the peristaltic pump is operated with the cartridge in a recirculation mode wherein the liquid medical waste is drawn from the fluid reservoir, through the detection window, through the conduit assembly, and into the fluid reservoir. A fluid level is detected with a fluid level sensor. The first and second actuators of the console are actuated based on the controller so as to move the cartridge from the recirculation mode to a purge mode in which the liquid medical waste is directed through the conduit assembly and through the first outlet fitting. The method includes estimating blood loss based on an analysis of the liquid medical waste in the purge mode.
[0016] According to an eleventh aspect, a method of performing a cleaning cycle with the cartridge is provided. The method includes operating the peristaltic pump with the cartridge in the recirculation mode in which the cleaning fluid is drawn from the fluid reservoir, through the detection window, through the conduit assembly, and into the fluid reservoir. The first and second actuators of the console by the controller to move the cartridge from the recirculation mode to the purge mode in which the cleaning fluid is directed through the conduit assembly and through the first outlet fitting. An optical characteristic of the cleaning passing through the detection window is detected with the sensor assembly. A notification is provided on the display as to whether the cartridge is sufficiently clean for reuse based on the optical characteristic.
[0017] Any of the above aspects can be combined in part or in whole with any other aspect unless indicated to the contrary. Any of the above aspects, whether combined in part or in whole, can be further combined with any of the following implementations, in full or in part.
[0018] In certain implementations, the first conduit of the conduit assembly includes an outlet coupled to the first outlet fitting and an inlet coupled to a conduit junction, the second conduit includes an inlet coupled to the conduit junction and an outlet coupled to the housing, and third conduit includes an outlet coupled to the conduit junction and an inlet coupled to the housing. In some implementations, the first outlet fitting is positioned near an upper wall of the housing and is configured to provide an overfill outlet for the liquid medical waste. A second outlet fitting may be in fluid communication with the fluid reservoir. The second outlet fitting is configured to be removably coupled with a second suction tube operably coupled to the external vacuum source. The second outlet fitting may be positioned near an upper aspect of the housing for the external vacuum source to provide overfill relief to the fluid reservoir. To that end, the second outlet fitting may be configured to be removably coupled with a second suction tube to provide overfill relief to the fluid reservoir by providing a means through which fluid is drawn from the fluid reservoir through the second outlet fitting without passing through the detection block.
[0019] In certain implementations, the housing further defines a compartment and an interior barrier separating the fluid reservoir and the compartment. The first conduit and the second conduit may be disposed within the compartment, and the housing may include tube management geometries which extend from the interior barrier and into the compartment. The housing may further include a first projection disposed within the compartment and aligned with the first lateral aperture, and a second projection disposed within the compartment and aligned with the second lateral aperture. The first and second projections are configured to facilitate flow control-based pinching of a respective one of the exposed portions of the first and second conduits with actuation of a respective one of the first and second actuators of the console. The first and second projections may include an arcuate face. Further, the first and second projections may extend from the interior barrier towards a respective one of the first and second lateral apertures. The first and second actuators may be first and second pistons which are actuated by the console.
[0020] In certain implementations, the cartridge may include a first weir arranged between the second conduit and the fluid reservoir, and a second weir arranged between the first conduit and the fourth conduit. Further, the weirs may be configured to be acted on by the actuators of the console to selectively move the cartridge between the fill mode and the purge mode. More specifically, the second weir may block fluid flow between the first conduit and the fourth conduit when depressed, and the cartridge may be configured to be in the fill mode when the first weir is unpressed and the second weir is depressed. Additionally, the first weir may block fluid flow between the second conduit and the fluid reservoir when depressed, and the cartridge may be configured to be in the purge mode when the first weir is depressed and the second weir is unpressed. In some implementations, the third conduit may be coupled to an outlet of the detection block, the first conduit may be coupled to the third conduit, the fourth conduit may be coupled to the first conduit and the second conduit, and the second conduit may be coupled to the fourth conduit. At least one of the first conduit, the second conduit, the third conduit, and the fourth conduit may be defined by the housing of the cartridge.
[0021] As mentioned, the fluid within the detection block may be analyzed by the sensor assembly of the console. As such, the detection block may include upper and lower surfaces respectively defining upper and lower openings that are aligned to form the detection window. The detection block may further include a lateral surface extending between the upper and lower surfaces which defines a lateral opening that further forms the detection window. The detection block may extend perpendicularly from an inner side of the housing. The detection block may have a thickness defined between the upper and lower surfaces which is less than 1.0 centimeter. The detection block may extend from an interior barrier of the housing. The detection block may also include seals disposed at interfaces between the fluid channel and interior ports in fluid communication with the fluid reservoir and/or the conduit assembly.
[0022] The cartridge may further include at least one fluid level sensor coupled to the housing and disposed within the fluid reservoir. An electronic connector may be coupled to the housing and in electronic communication with the at least one level sensor. The fluid level sensors may be resistive sensors, capacitive sensors, elongates strips, and/or conductive strips. The cartridge may also include a protrusion positioned adjacent each of the at least one fluid level sensor which are configured to minimize bubbles within the liquid medical waste. These protrusions may be spikes.
[0023] In certain implementations, the cartridge is configured to be reused only a certain amount of times and/or communicate usage parameters to the console. To that end, the cartridge may include a radiofrequency identification tag coupled to the housing. The cartridge may even include a first identification tag disposed on the housing and a second identification tag disposed on the detection block. Additionally or alternatively, the detection block may be removably coupled to the housing to facilitate cleaning/replacement.
[0024] In implementations including the foam shield, the plurality of barriers may include at least one of a lower barrier, an upper inner barrier, and an outer inner barrier. For example, the lower barrier may be ramped, the inner upper bander may be V-shaped, and/or the outer upper barrier may be V-shaped and contoured to the inner upper barrier. The inner upper banner may further define a channel inlet opening within the void space. The channel inlet opening may be vertically aligned with the lower inlet opening. The channel outlet opening may be horizontally aligned in elevation with the channel inlet opening. Further, the banners further may further include a first side barrier extending between the outer upper barrier and the lower inlet opening and/or a second side barrier extending between the inner upper barrier and the lower barrier.
[0025] The housing may include a front wall, a rear wall, and the opposing sidewalls, the inlet fitting and the outlet fitting may extend from the front wall, and the lower inlet opening may be positioned closest to the front wall relative of the void space. The channel outlet opening may be positioned closest to the rear wall relative to the void space. The outer upper barrier may define a channel outlet opening positioned external to the void space. The channel may be disposed above the channel outlet opening such that air or foam with the liquid medical waste is drawn into the void space under influence of vacuum as the liquid medical waste is being drawn out of the void space through the lower inlet opening during purging of the cartridge. It is contemplated that the console includes a plurality of capacitive sensors and the cartridge includes more than one foam shield to increase the accuracy of the capacitive sensors. [0026] In implementations, including the float assembly, the float casing may further include stiffening members disposed within and extending between opposing sides. The float casing may include lateral sidewalls separated by an endwall, with one of the lateral sidewalls is slidably positioned adjacent to an outer sidewall of the housing. The lateral sidewalls may be planar and oriented parallel to one another. The endwall may include an arcuate portion and two flat portions. The float casing may define a recess into which the magnetic element is meant to be disposed, such as by a press fit engagement. To break surface tension, the float assembly may include protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste. The protrusions may include conical or dome-shaped geometries, which may extend outwardly from the endwall of the float casing. Where the endwall includes the arcuate portion and flat portion(s), the geometries may extend outwardly from the flat portion(s). Further, the protrusions may include an elongate ridge extending outwardly from the lateral sidewalls. In this case, the elongate ridge may be arcuate in a direction of a sweeping motion of the float casing about the pivot. The float casing may be substantially disc shaped.
[0027] In implementations directed to the cleaning cycle with the cartridge, the methods may further include determining, with the controller, that the cartridge is not sufficiently clean for reuse if the optical exceeds a predetermined threshold. The console may include an identification reader to read an identification tag coupled to the cartridge. Data from the identification tag is received, wherein the data includes a number of uses of the cartridge. The number is compared against a predetermined number. A notification may be provided on the display that the cartridge is not sufficiently clean for reuse if the number of uses exceeds the predetermined number. A prompt may be provided on the display to inquire the cleaning cycle is desired if the number of uses does not exceed the predetermined number. The method may further include iterating, with the controller, the number of uses associated with the cartridge during or after completion of the cleaning cycle, and the iterated number of uses may be written to the identification tag.
[0028] Additional inventive aspects of the present disclosure will be appreciated from the description below and accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS [0029] FIG. 1 is a front perspective view of an implementation of a medical waste collection system. A console is situated on the medical waste collection system, and a cartridge is coupled to the console.
[0030] FIG. 2 is a front perspective view of the console and an implementation of the cartridge configured to be removably inserted therein.
[0031] FIG. 3 is a sectional view of the console of FIG. 2.
[0032] FIG. 4 is a front perspective view of an implementation of the cartridge.
[0033] FIG. 5 is an exploded view of an implementation of the cartridge of FIG. 4.
[0034] FIG. 6 is a partial view of the cartridge of FIG. 4 operating in a recirculation mode.
[0035] FIG. 7 is a partial view of the cartridge of FIG. 4 operating in a purge mode.
[0036] FIG. 8 is a front perspective view of another implementation of a cartridge.
[0037] FIG. 9 is a side elevation view of the cartridge of FIG. 8 with internal components shown in phantom.
[0038] FIG. 10 is a perspective view of the cartridge of FIG. 8 operating in a recirculation mode.
[0039] FIG. 11 is a perspective view of the cartridge of FIG. 8 operating in a purge mode.
[0040] FIG. 12 is a perspective view of yet another implementation of the cartridge.
[0041] FIG. 13 is a side sectional view of the cartridge of FIG. 12.
[0042] FIG. 14 is a top sectional view of the cartridge of FIG. 12.
[0043] FIG. 15 is a detailed view of the cartridge of FIG. 14 within circle 15.
[0044] FIG. 16 is an exploded view of yet another implementation of the cartridge.
[0045] FIG. 17A is a perspective sectional view of the cartridge of FIG. 16 in a fill mode.
[0046] FIG. 17B is a perspective sectional view of the cartridge of FIG. 16 in a purge mode.
[0047] FIG. 18 is a perspective view of yet another implementation of the cartridge.
[0048] FIG. 19 is a flow diagram describing a method of controlling use of the cartridge. [0049] FIG. 20 is a perspective view of a cartridge including an implementation of fluid level sensors.
[0050] FIG. 21 is a side sectional view of a cartridge including a foam shield.
[0051] FIGS. 22A-22F are side sectional views of the foam shield of FIG. 21.
[0052] FIG. 23 is a sectional view of a cartridge including a float assembly along with a portion of a console including fluid level sensors.
[0053] FIG. 24 is a partial view of the cartridge of FIG. 23.
[0054] FIG. 25 is a perspective view of a sensor assembly of one implementation of a console.
[0055] FIG. 26 is a perspective view of a biasing member of one implementation of a console.
[0056] FIGS. 27 A and 27B show graphed response curves correlating the detected optical signal to the estimated blood concentration.
[0057] FIG. 28 is a circuit diagram of a logarithmic amplifier.
DETAILED DESCRIPTION
I. System Overview
[0058] FIG. 1 shows a medical waste collection system 20 for collecting waste material generated during medical procedures. The medical waste collection system 20 includes a cart 22, and wheels 24 for moving the cart 22 within a medical facility. At least one waste container 26 is supported on the cart 22 and defines a waste volume for receiving and collecting the waste material. The cart 22 includes a front casing 46 that defines at least one cutout or window 48 to expose a portion of the waste container 26. In implementations in which there is more than one waste container, an upper waste container may be positioned above a lower waste container, and a valve (not shown) may facilitate transferring the waste material from the upper waste container to the lower waste container. A vacuum source 30 is supported on the cart 22 and configured to draw suction on the waste container(s) 26 through one or more internal lines. The vacuum source 30 may include a vacuum pump, and a vacuum regulator configured to regulate a level of the suction drawn on the waste container(s). Suitable construction and operation of several subsystems of the medical waste collection system 20 are disclosed in commonly-owned United States Patent No. 7,621,898, issued November 24, 2009, United States Patent No. 10,105,470, issued October 23, 2018, and United States Patent No. 11 ,160,909, issued November 2, 2021, the entire contents of each being hereby incorporated by reference.
[0059] The medical waste collection system 20 includes at least one receiver 28 supported on the cart 22. The receiver 28 defines an opening sized to removably receive at least a portion of a manifold 34. A suction path may be established from a suction tube 36 to the waste container 26 through the manifold 34 removably inserted into the receiver 28. A suction tool 40 may be used to draw medical waste into the suction tube 36 and to be collected within the waste container 26. In any case, the vacuum generated by the vacuum source 30 is drawn on the suction tubes 36, and the waste material is drawn from the surgical site through the suction tool 40, the suction tube 36, a cartridge (introduced below), the manifold 34, and the receiver 28 to be finally collected in the waste container 26. The manifold 32 may be a disposable component with exemplary implementations of the receiver 28 and the manifold 32 disclosed in commonly- owned United States Patent No. 10,471,188, issued November 12, 2019, the entire contents of which are hereby incorporated by reference. Alternatively, it is contemplated that the devices and methods disclosed herein may be used with a freestanding canister and a facility-integrated vacuum system.
[0060] With continued reference to FIG. 1, the waste collection system 20 includes a console 100 configured to receive a cartridge 200. The console 100 may include a display 52 that optionally includes input means. For example, the display 52 may be a touch-screen display configured to receive touch commands from a user. In the illustrated implementation, the waste collection system 20 includes the display 52 arranged on a front face of the console 100 as well as a secondary display 53 arranged on a front of the cart 22. The secondary display 53 may also be configured to receive user input, such as via a touch screen. In some implementations, the system 20 includes both displays 52, 53. In other implementations, the system 20 includes only one of the displays 52, 53. The console 100, display 52, and/or secondary display 53 are in electronic communication with the controller 42.
[0061] Referring to FIGS. 2 and 3, the console 100 and the cartridge 200 a e shown in more detail. The console 100 includes a casing 102 surrounding and containing the remaining components of the console 100, such as the controller 42. The console 100 further includes a cartridge receiver 110 defining an opening 112 in the casing 102, and the opening 112 is configured to removably receive the cartridge 200. On the inside of the console 100, as shown in FIG. 3, a peristaltic pump 114 is included and is configured to act upon conduits of the cartridge 200 as further described below. Further, the console 100 includes a sensor assembly 120 configured to emit light into and detect light passing through the cartridge 200. As such, the sensor assembly 120 is configured to detect characteristics of liquid medical waste within or passing through cartridge 200. For example, the sensor assembly 120 may be used to determine the estimated blood loss (eBL) drawn from a patient/surgical site through the suction tool 40 or other device.
II. Cartridge Implementations
[0062] Referring to FIGS. 4 and 5, an implementation of the cartridge 200 includes a housing 210 within which certain elements are disposed. The housing 210 includes a base 211, a first sidewall 212, a second sidewall 214, a third sidewall 216, and a top 217. As shown in FIG. 5, the base 211, the sidewalls 212, 214, 216, and the top 217 define two different sections of the cartridge 200. First, a fluid reservoir 220 is defined between the first and third sidewalls 212, 216 and the top and base 217, 211 of the housing 210. As fluid is drawn into the cartridge 200, it is at least initially disposed within the fluid reservoir 220. To that end, the cartridge 200 includes an inlet fitting 222 into which fluid is drawn via the vacuum source (e.g., the suction tool 40). As fluid is drawn through the inlet fitting 222 and into the cartridge 200, the fluid becomes at least temporarily trapped within the fluid reservoir 220 (shown in phantom in the FIGS. 4 and 5). More specifically, the fluid descends into the fluid reservoir 220 and becomes mixed with any fluid already collected within the fluid reservoir 220. To that end, the inlet fitting 222 may be positioned near an upper aspect of the housing 210 such that fluid descends into the fluid reservoir 220 under the influence of gravity. Agitation from the descending fluid may help mix the fluid and increase the homogeneity of the fluid. Second, the housing 210 defines a compartment 218 between the second and third sidewalls 212, 214 and the top and base 217, 211. Within the compartment 218, other components of the cartridge 200 are disposed. The third sidewall 216 may act as an interior barrier separating the fluid reservoir 220 and the compartment 218. Further, the second sidewall 214 may define a first lateral aperture 234 and a second lateral aperture 235. The lateral apertures 234, 235 are defined at specific sections of the second side wall 214 such that they align with conduits of the cartridge 200 and actuators of the console 100. More specifically, the apertures 234, 235 may be defined such that portions of the first and second conduits 244, 245 are exposed to the console 100 via the apertures 234, 235. In some implementations, such as the illustrated implementation, the lateral apertures 234, 235 may be cruciform in shape. Further, in some implementations, the first lateral aperture 234 is positional distal to the second lateral aperture 235 and/or closer to a front of the housing 210 (i.e., closer to the inlet and outlet fittings, 222, 226, 230) than the second lateral aperture 235. In these implementations, the first lateral aperture 234 may also be positioned closer to a detection block (introduced below) than the second aperture 235.
[0063] The cartridge 200 also includes a detection block 250 which is arranged on the cartridge 200 such that the detection 250 block aligns with a sensor assembly (described below) of the console 100 when the cartridge 200 is seated within the cartridge receiver 110 of the console 100. In the illustrated implementation, the detection block 250 is disposed near the base 211 of the housing 210 so that fluid may be drawn therethrough even when the fluid level within the fluid reservoir 220 is low. Further, the detection block 250 extends perpendicularly from the second sidewall/interior barrier 214 of the housing 210 to align with the sensor assembly 120 of the console 100 when the cartridge 200 is within the receiver 110. The detection block 250 defines a fluid channel 252 in fluid communication with the fluid reservoir 220 such that fluid can pass from the fluid reservoir 220, through the detection block 250 along the fluid channel 252, and either back into the fluid reservoir 220 or out of the cartridge 200 via an outlet, such as a first outlet fitting or a second outlet fitting (see FIGS. 7-8 and 11-12). The detection block may include an upper surface 257, a lower surface 258, and a lateral surface 259. In order to avoid fluid from escaping the fluid channel 252 or the fluid reservoir 220, seals (not shown) may be disposed at interfaces between the fluid channel 252 and interior ports 221 of the cartridge 200. In the illustrated implementation, the one of the interior ports 221 is in fluid communication with the fluid reservoir 220 and another of the interior ports 221 is in fluid communication with the third conduit 246.
[0064] The detection block 250 further includes at least one detection window 254 which is transparent and allow light to pass through the fluid flowing through the detection block 250 along the fluid channel 252. For example, in the illustrated implementation, each of the upper, lower, and lateral surfaces 257, 258, 259 define an upper opening, a lower opening, and a lateral opening, respectively. The upper, lower, and lateral openings may form the detection windows 254. The detection windows 254 are aligned with one another such that light may pass into one detection window 254 and out of at least one of the other detection windows 254. This allows the sensor assembly 120 to emit light into one detection window 254 and through fluid disposed between the two detections windows 254, and then detect that light as it passes out of at least one of the other detections windows 254.
[0065] In an optional implementation, the detection block 250 may be removably coupled to the remainder of the cartridge 200. This allows the detection block 250 to be replaced after a specific number of uses or a certain amount of wear. For example, the detection block 250 may be replaced after every use of the cartridge 200. In another example, the detection block 250 may be designed to be replaced after ten uses or when the detection window 254 become at least partially occluded, whichever happens first. In yet another example, the detection block 250 may be replaced solely based on a performance of the detection block 250 as determined by calibration signals transmitted through the detection block 250 by the sensor assembly 120, such as in the method below. In such an example, the sensor assembly 120 may transmit a calibration signal through one of the detection windows 254, receive the calibration signal after it has passed through another of the detection windows 254, and compare the received calibration signal against a predetermined calibration metric.
[0066] In order to make sure the detection block 250 is readily removable from, but also secure within, the housing 210 of the cartridge 200, the detection block 250 may be secured to a mounting flange 219 extending from the third side wall 216 (i.e., the interior barrier). The detection block 250 may include a mounting interface 251 configured to mate with the mounting flange 219. Additionally, the housing 210 of the cartridge 200 may include a slot 233 defined by the second sidewall 214 which is arranged to receive the detection block 250 as shown in the figures. Thus, the detection block 250 can be removably coupled to the mounting flange 219 and disposed within the slot 233 to removably secure the detection block 250 to the housing 210 of the cartridge 200.
[0067] The cartridge 200 further includes a first outlet fitting 226 and a second outlet fitting 230 through which fluid may exit the cartridge 200. The outlet fittings 226, 230 may be coupled to the housing 210 of the cartridge 200. Depending on which mode the cartridge 200 is in, fluid may exit through one (or both) of the outlet fittings 226, 230. As described in more detail and with reference to FIGS. 6 and 7 below, the second outlet fitting 230 may be in direct fluid communication with the fluid reservoir 220. This ensures that a suction path between the inlet 222 and the second outlet fitting 230 may remain open and independent from other functions of the cartridge 200 as described below. The first outlet fitting 226, on the other hand, may be in direction fluid communication with a first conduit (introduced below) such that the fluid is drawn from the fluid reservoir 220, through the detection block 250, through the conduit junction 242, and finally out of the cartridge 200 via the first outlet fitting 226. A first outlet suction tube 228 may be removably coupled to the first outlet fitting 226 and an external vacuum source to allow fluid to be drawn out of the cartridge 200 via the first outlet suction tube 228 by the external vacuum source. Similarly, a second outlet suction tube 232 may be removably coupled to the second outlet fitting 226 and the external vacuum source to allow fluid to be drawn out of the cartridge 200 via the second outlet suction tube 232. The external vacuum source coupled to the second outlet suction tube 232 may be the same or different than the vacuum source drawing fluid through the first outlet suction tube 228. Further, the external vacuum source may be the vacuum source 30 within the cart 22 of the waste collection system 20, and the vacuum source 30 may draw fluid from the cartridge 200 into the waste container 26 through one or both of the first and second suction tubes 228, 232.
[0068] Referring to FIGS. 6 and 7, the cartridge 200 is shown with the compartment 218 exposed. Within the compartment 218, the various conduits and fluid paths are shown according to one implementation. The cartridge 200 is shown operating in a recirculation mode in FIG. 6 and a purge mode in FIG. 7. Depending on the mode, fluid is moved differently within the cartridge 200. In both modes of operation, the cartridge 200 is disposed within the console 100 and the peristaltic pump 114 is moving fluid within the cartridge 200. In FIGS. 6 and 7, fluid has already been drawn into the fluid reservoir 220 via the inlet fitting and inlet suction tube 222, 224. The fluid disposed within the fluid reservoir 220 is then drawn into the detection block 250 as the peristaltic pump 114 (not shown in FIGS. 6 and 7) acts on a third conduit 246 of a conduit assembly 240 and provides suction as shown by the arrows in FIG. 6. For this to be accomplished, the third conduit 246 may is configured to be arranged in operable engagement with the peristaltic pump 114. Once the fluid passes through the detection block 250 and into the third conduit 246, the fluid reaches a conduit junction 242. At the conduit junction 242, fluid either travels through a second conduit 245 and back into the fluid reservoir 220 or through a first conduit 244 and out of the cartridge 200 through the first outlet suction tube 228. To ensure optimal arrangement of the conduits 244, 245, 246 of the conduit assembly 240, the cartridge 200 may include tube management geometries 263 within the compartment 218 that extend from the third sidewall 216 towards the second sidewall 214.
[0069] A first actuator 160 and a second actuator 161 of the console 100 are shown relative to the cartridge 200 in an exaggerated fashion to describe the operation of the cartridge 200. The first and second actuators 160, 161 may include a first piston and a second piston, respectively. The first and second pistons may assist the console 100 in actuating the actuators 160, 161. In some implementations, the first and second actuators 160, 161 are controlled by first and second solenoids which produce a magnetic field to control the actuators 160, 161 (e.g., by actuating the pistons). The first and second actuators 160, 161 may pass through the first and second lateral apertures 234, 235, respectively, of the cartridge 200. Further, the cartridge 200 may include a first conduit seat 260 and a second conduit seat 261 arranged so that the first and second actuators 160, 161 urge the first and second conduits 244, 245 against the first and second conduit seats 260, 261, respectively. The conduit seats 260, 261 may increase the efficacy of the actuators 160, 161 in pinching the conduits 244, 245 closed and preventing fluid from flowing therethrough. To that end, the conduit seats 260, 261 may project from the third sidewall 216 (i.e., the internal barrier) towards the second sidewall 216 and be shaped to have an arcuate face as shown in the figures. Other shapes are contemplated.
[0070] Referring to FIG. 6, the first actuator 160 is shown actuated toward the first conduit seat 260 so that fluid cannot flow between the conduit junction 242 and the first conduit
244. Simultaneously, the second actuator 161 is shown pulled back away from the second conduit seat 261 so that fluid may flow between the conduit junction 242 and the second conduit
245. With the actuators 160, 161 in these positrons, the cartridge 200 is in the recirculation mode briefly mentioned above. In the recirculation mode, fluid is drawn from the fluid reservoir 220, through the detection block 250, through the third conduit 246, through the second conduit 245, and back into the fluid reservoir 220. The recirculation mode may be activated in order to “mix” the fluid with itself until the fluid is largely homogenous. This allows the cartridge 200 to ensure that the fluid flowing through the fluid channel 252 of the detection block 250 is an accurate representation of all fluid within the cartridge 200. Further, as shown in the figures, the second conduit 245 may be coupled to an upper aspect of the housing 210 of the cartridge 200 such that recirculated fluid descends into the fluid reservoir 220 under the influence of gravity. This may help to reduce the amount of recirculation that is necessary because the fluid becomes at least partially mixed when the fluid exits the second conduit 245 and falls into the fluid reservoir 220.
[0071] As described in Section IV below, fluid levels sensors may detect a fluid level within the fluid reservoir 220 and send signals to the controller 42 to switch the cartridge 200 into the purge mode when the fluid level within the fluid reservoir 220 reaches a predetermined fluid level. For example, the cartridge 200 may be switched into the purge mode when the fluid level sensors detect that the fluid reservoir 220 is filled to or exceeding 50% capacity. In the purge mode, fluid is drawn out of the fluid reservoir 220 through the first outlet fitting 226 via the first outlet suction tube 228.
[0072] Referring to FIG. 7, the first actuator 160 is shown spaced apart from the first conduit seat 260 so that fluid may flow between the conduit junction 242 and the first conduit 244. At the same time, the second actuator 161 is shown actuated toward the second conduit seat 261 so that fluid cannot flow between the conduit junction 242 and the second conduit 245. With the actuators 160, 161 in these positions, the cartridge 200 is in the purge mode briefly mentioned above. In the purge mode, fluid is drawn from the fluid reservoir 220, through the detection block 250, through the third conduit 246, through the first conduit 244, and through the first outlet fitting 226 (see FIGS. 4 and 5).
[0073] The purge and recirculation modes may be activated based a homogeneity of the fluid. More specifically, the recirculation mode may be activated to effectively “mix” the fluid within the cartridge until that fluid reaches a threshold homogeneity, and the purge mode may be activated once the fluid reaches a homogeneity equal to or greater than the threshold homogeneity. For example, the controller 42 may detect that the characteristics of the fluid flowing through the detection block 250 are changing quickly, which may be indicative of heterogenous fluid. Since homogenous fluid is preferred when determining characteristics of the fluid as a whole, the controller 42 may cause the cartridge 200 to stay in the recirculation mode until the fluid reaches the threshold homogeneity. Once the fluid is sufficiently homogenous, the purge mode may be activated. The controller 42 may determine the characteristics of the fluid after the fluid reaches the homogeneity threshold. In some cases, the controller 42 may cause the cartridge 200 to be in the recirculation mode to mix the fluid, switch to the purge mode once the fluid is mixed, and characterize the fluid flowing through the detection block 250 and out of the cartridge 200 via the second outlet suction tube 232. The suction tool 40 is capable of drawing fluid into the cartridge regardless of which mode of operation the cartridge is in. This is advantageous because it allows the user of the suction tool 40 to continue using the tool 40 while the fluid is drawn from the surgical site and into the cartridge 200 without the efficacy of the tool 40 being compromised by the remainder of the system 20.
[0074] During operation, suction is drawn on the first outlet fitting 230 to create a negative pressure within the fluid reservoir. This causes suction to be drawn on the inlet fitting 222, which urges fluid through the suction tool 40 and into the fluid reservoir 220 via the inlet fitting 222. When the cartridge 200 is in the purge mode, fluid may be urged out of the fluid reservoir 220 by the peristaltic pump 114. That said, in some implementations, fluid may be drawn into the fluid reservoir 220 quicker than the fluid exits the cartridge 200. For example, the peristaltic pump 114 may move fluid within the cartridge 200 at a slower rate than fluid is urged into the cartridge 200 by the suction drawn on the second outlet fitting 230. This may also occur during the recirculation mode, as fluid is still being drawn into the cartridge 200 but is not otherwise being drawn out of the first outlet fitting 226. As such, the cartridge 200 may include the second outlet fitting 230 to provide overfill relief for the cartridge 200. More specifically, if the fluid level within the fluid reservoir 220 reaches the outlet fitting 230, the suction being drawn on the second outlet fitting 230 may draw fluid out of the cartridge 200 through this fitting 230. Further, the second outlet fitting 230 may be positioned near an upper aspect of the housing 210, like shown in the illustrated implementation, to ensure that only a necessary amount of fluid is drawn out of the cartridge 200 when the fluid level increases to a high level. This is advantageous because fluid drawn out of the cartridge 200 via the second outlet 230 does not pass through the detection block 250, which may decrease the accuracy of fluid characterization by the console 100. By reducing the amount of fluid drawn out of the cartridge 200 through the second outlet 230, the accuracy of fluid characterization is maintained as much as possible.
[0075] With reference to FIGS. 1 and 6-7, fluid is drawn into the cartridge 200 via the suction tool 40 and the (inlet) suction tube 36, 224. Once within the fluid reservoir 220 of the cartridge 200, the different modes of the cartridge 200 permit the fluid to be moved within and out of the fluid reservoir 220 in the different ways described above. FIG. 1 shows where the fluid goes when drawn out of the cartridge 200 via either of the outlets 226, 230. More specifically, after leaving the cartridge 200, the fluid flows into the manifold 34 and then into the waste container 26. [0076] Referring to FIGS. 8- 11 , an alternative implementation of the cartridge 200 is shown. In this implementation, the cartridge 200 has a unified design such that only the second lateral aperture 235 is necessary for switching the operating mode of the cartridge 200. Although not shown in the figures, the actuators 160, 161 of the console 100 are arranged differently than the implementation shown in FIGS. 6 and 7. Instead of being positioned as shown in the prior figures, the actuators 160, 161 of the implementation shown in FIGS. 8-11 are both arranged so that they can be actuated through the second lateral aperture 235 and urge the first and second conduits 244, 245 against the third sidewall 216 and/or conduit seats (not shown) to pinch the corresponding conduit 244, 245 closed. Further, the cartridge 200 of this implementation only includes a single outlet in the form of the first outlet fitting and first outlet suction tube 228.
[0077] Referring to FIG. 10, the first actuator 160 has been actuated toward the first conduit 244 so that fluid cannot flow between the conduit junction 242 and the first conduit 244. Simultaneously, the second actuator 161 is spaced apart away from the second conduit 245 so that fluid may flow between the conduit junction 242 and the second conduit 245. With the actuators 160, 161 in these positions, the cartridge 200 is in the recirculation mode like the cartridge 200 of FIG. 6. Like the prior implementation of FIG. 6, in the recirculation mode, fluid is drawn from the fluid reservoir 220, through the detection block 250, through the third conduit 246, through the second conduit 245, and back into the fluid reservoir 220.
[0078] Referring to FIG. 11, the first actuator 160 has been pulled back away from the first conduit 244 so that fluid may flow between the conduit junction 242 and the first conduit 244. At the same time, the second actuator 161 has been actuated toward the second conduit 245 so that fluid cannot flow between the conduit junction 242 and the second conduit 245. With the actuators 160, 161 in these positions, the cartridge 200 is in the purge mode like the cartridge 200 of FIG. 7. In the purge mode, fluid is drawn from the fluid reservoir 220, through the detection block 250, through the third conduit 246, through the first conduit 244, and through the first outlet fitting 226.
[0079] Although not shown in the figures, it is further contemplated to control the flow of fluid with only one actuator, which is herein referred to as the actuator 160. In such an implementation, the actuator 160 is provided access to both the first and second conduits 244, 245 via the second lateral aperture 235. The actuator 160 may be moved by itself or another component of the console 100. Since there is only one actuator in this implementation, the actuator 160 may be moved between a first state in which the actuator 160 can be urged against the first conduit 244 and a second state in which the actuator 160 can be urged against the second conduit 245. For example, the actuator 160 could be coupled to a rotating element which moves the actuator 160 between the first and second states.
[0080] Ref erring to FIGS. 12-15, yet another alternative implementation of the cartridge 200 is shown. In this implementation, the cartridge 200 is designed such that the conduit assembly 240 and the detection block 250 are formed integrally with the second sidewall 214 of the housing 210. Although the detection block 250 is oriented relative to the housing 210 different than in other implementations, it is further contemplated to adjust the components of the console 100 to accommodate the different shape of the cartridge 200. Since the conduits 244, 245, 246 and the conduit junction 242 are formed integrally with the housing 210, the housing 210 does not need to define a compartment separate from the fluid reservoir 220 (e.g., like the compartment 218 shown in FIG. 4). As such, the cartridge 200 is simplified so that the first and second sidewalls 212, 214 define the fluid reservoir 220. Further, the apertures 234, 235 are sealed by a first weir 264 and a second weir 267, respectively, so that fluid stored in the fluid reservoir 220 cannot escape through the second sidewall 214. The weirs 264, 267 each include a support portion 265, 268 coupled to the housing 210 (i.e., the apertures, 234, 235), and a deformable portion 266, 269 coupled to the support portion 265, 268 and configured to be depressed to control the operating mode of the cartridge 200. To this end, the weirs 264, 267 may be controlled by the actuators 160, 161 as described in detail below.
[0081] The fluid is drawn into the cartridge 200 through the inlet fitting 222 via the vacuum source 30 and/or the peristaltic pump 114 acting on the third conduit 246. As fluid in drawn into and through the inlet fitting 222, the fluid flows into the fluid reservoir 220. As shown in the figures, the cartridge 200 may include a curved wall 227 arranged near’ the inlet fitting 222 and within the fluid reservoir 220. The curved wall 227 is meant to decrease the velocity of the fluid flowing into the inlet fitting 222 in order to reduce the amount of foam generated within the fluid reservoir 220. As discussed below, reducing the amount of foam introduced into the cartridge 200 also reduces the potential for false fluid level readings by the fluid level sensors 270.
[0082] The cartridge 200 shown in FIGS. 12-15 may operate in the recirculation mode or the purge mode like the previously described implementations. Regardless of operating mode, once drawn into the inlet fitting 222, the fluid falls into the fluid reservoir 220 towards the detection block 250. During recirculation and purge modes, the fluid within the fluid reservoir 220 is drawn through the internal port 221 disposed between the fluid reservoir 220 and the fluid channel 252 of the detection block 250. Subsequently, the fluid is drawn into the fluid channel 252, through the third conduit 245, and towards the fluid junction 242. This is shown in FIG. 13 as a first fluid path Pl. After the fluid moves along the first fluid path Pl and reaches the fluid junction 242, the fluid moves along a second fluid path P2 and back into the fluid reservoir 220 if the cartridge 200 is in the recirculation mode, or along a third fluid path P3 and out of the outlet 226 if the cartridge 200 is in the purge mode.
[0083] The weirs 264, 267 are used to place the cartridge 200 into the desired operation mode. As can be seen in FIGS. 14 and 15, the deformable portion 266 of the first weir 264 is connected to a movable conduit 247, and the movable conduit 247 is in fluid communication with the second conduit 245. Further, the movable conduit 247 provides fluid communication between the fluid reservoir 220 and the second conduit 245 when the first weir 264 is unpressed. When the first weir 264 is depressed, however, the movable conduit 247 is urged against a first valve feature 278 disposed within the fluid reservoir 220, and fluid communication between the reservoir 220 and the second conduit 245 is interrupted by the first valve feature 278. The second weir 267, on the other hand, includes a second valve feature 279 that is connected to the deformable portion 269 of the second weir 267. The second valve feature 279 can be urged into a first hole 223 of the first conduit 244 to control fluid communication between the first conduit 244 and the outlet 226. Thus, fluid communication between the first conduit 244 and the outlet 226 is allowed when the second weir 267 is unpressed, and this fluid communication is interrupted when the second weir 267 is depressed. Overall, the cartridge 200 is in the recirculation mode when the first weir 264 is unpressed while the second weir 267 is depressed, and in the purge mode when the first weir 264 is depressed while the second weir 267 is unpressed.
[0084] Like the other implementations of the cartridge 200, the cartridge 200 shown in FIGS. 12-15 provides a method of removing fluid from the fluid reservoir 220 once the fluid reaches a predetermined level. Put simply, fluid can be passively removed through a second hole 225 defined by the outlet 226. The second hole 225 permits fluid to flow from the reservoir 220 and into the outlet 226, and fluid will be automatically suctioned out of the reservoir 220, into the second hole 225, and out of the outlet 226 when the fluid level within the reservoir 220 is at or above the second hole 225. This way, the cartridge 200 will automatically avoid fluid overfill while in the recirculation (or purge) mode as suction is drawn on second hole 225 via the outlet 226.
[0085] In the previously described implementations of the cartridge 200, the peristaltic pump 114 is used to move fluid within and out of the fluid reservoir 220. As such, the rate at which fluid can be removed from the cartridge 200 is limited by the rate at which the pump 114 can move the fluid. In some cases, however, the suction drawn on the suction tool 40 leads to more fluid being introduced through the inlet 222 than removed via the first outlet 226. Therefore, during events that cause a high volume of fluid to be suctioned into the cartridge 200, like when the surgeon cuts into the amniotic membrane and the amniotic fluid is released, it is possible for the cartridge 200 to fill, whereby any additional liquid will bypass the detection block 250 and lead to inaccurate blood quantification. To avoid this drawback, the cartridge 200 may be used without the peristaltic pump 114 as described below.
[0086] Referring to FIGS. 16-17B, yet another alternative implementation of the cartridge 200 is shown. In this implementation, the cartridge 200 may be used without the peristaltic pump 114, and instead utilize the suction force drawn on the first outlet 226 (e.g., the suction generated by the vacuum source 30) to move fluid into, within, and out of the cartridge 200. More specifically, the first outlet 226 is in fluid communication with the inlet 222 and suction drawn on the first outlet 226 urges fluid into the suction tool 40, through the inlet 222, and into the fluid reservoir 220. In prior implementations, the cartridge 200 is operable in the recirculation mode and the purge mode. Since the cartridge 200 of FIGS. 16-17B does not require a peristaltic pump, the cartridge 200 shown in these figures is implemented slightly differently and is operable in a fill mode and a purge mode.
[0087] In FIG. 17A, the cartridge 200 is shown operating in the fill mode. Although not shown, the first weir 264 is unpressed and the second weir 267 is depressed when the cartridge 200 is in the fill mode. In this mode, fluid (and air) is drawn into the fluid reservoir 220 through the inlet 222. With the weirs 264, 267 being in the aforementioned positions, air within the fluid reservoir 220 can be drawn into the second conduit 245 through the first weir 264 while fluid may be prevented from entering the detection block 250 (or at least not urged into and through the detection block 250) because the second weir 267 is depressed and blocking fluid passage through the first and third conduits 244, 246. As illustrated as a first flow path Pl in FIG. 17A, the suction drawn on the outlet 226 draws air through the first weir 264, into the second conduit 245, into a fourth conduit 248, and out of the cartridge 200 through the outlet 226. As a result of the air being drawn out of the reservoir 220, a suction force is also generated on the inlet 222 and fluid is drawn from the surgical site and into the reservoir 220.
[0088] In FIG. 17B, the cartridge 200 is shown operating in the purge mode. Although not shown, the first weir 264 is depressed and the second weir 267 is unpressed when the cartridge 200 is in the purge mode. In this mode, like in the fill mode, fluid is drawn into the fluid reservoir 220 through the inlet 222. Since the first weir 264 is depressed and the second weir 267 is unpressed, fluid within the reservoir 220 is draw along a second flow path P2 such that the fluid flows through the detection block 250, through the third conduit 246, through the first conduit 244, past the second weir 267, through the fourth conduit 248, and out of the outlet 226. At the same time, the depressed first weir 264 blocks air/fluid from entering the second conduit 245.
[0089] As fluid is drawn through the detection block 250 during the purge mode, the sensor assembly 120 may be used to detect characteristics of the fluid flowing through the block 250 like in other implementations. Unlike other implementations, however, the controller 42 does not rely on characteristics of the peristaltic pump 114 to estimate a volume of fluid drawn out of the cartridge 200 since the peristaltic pump 114 is not used for this implementation. Instead, the cartridge 200 of FIGS. 16-17B may include a flow sensor 126 (e.g., an ultrasonic flow sensor) coupled to the housing 210 and configured to estimate a volume of fluid being drawn out of the cartridge 200 during the purge mode. In the figures, the flow sensor 126 is operably coupled to the third conduit 246 and estimates the volume of fluid flowing through the third conduit 246. In other implementations, the console 100 may include the flow sensor 126 arranged within the shell in a way that causes the flow sensor 126 to abut or be near the third conduit 246 (or other conduit 244, 245, 248) when the cartridge 200 is received within the receiver 110.
[0090] As described in Section IV below, fluid levels sensor(s) may detect a fluid level within the fluid reservoir 220 and send signals to the controller 42 to switch the cartridge 200 into the purge mode when the fluid level within the fluid reservoir 220 reaches a predetermined fluid level. For example, the cartridge 200 may be switched into the purge mode when the fluid level sensors detect that the fluid reservoir 220 is filled to or exceeding 50% capacity. At the same time, the cartridge 200 may be switched into the fill mode when the fluid level sensors detect that the fluid level within the fluid reservoir 220 is below a predetermined fluid level. For example, the cartridge 200 may be switched into the fill mode when the fluid level sensors detect that the fluid reservoir 220 is below 20% capacity.
[0091] Referring to FIG. 18, another implementation of the cartridge 200 is shown. In this implementation, the cartridge 200 has been modified to removably attach onto a canister 310 as a lid. Once attached, the canister 310 acts as the first sidewall 212 of the cartridge 200 and defines the fluid reservoir 220 between walls 312 of the canister 310 and the second sidewall 214 of the cartridge 200. The rest of the components of the cartridge 200 are contained within the compartment 218 defined between the second and third side walls 214, 216 similar to other implementations (e.g., those shown in FIGS. 4-11). The cartridge 200 may be detached from the canister 310, a secondary compartment element (not shown) may be coupled to the second sidewall 214 of the cartridge 200, and the cartridge 200 may then be inserted within the cartridge receiver 110. The secondary compartment element and second sidewall 214 may be define the fluid reservoir 220, similar to how the first and second sidewalls 212, 214 define the fluid reservoir 220 in other implementations.
III. Methods of Cleaning and Controlling Use of Cartridge
[0092] As described above, various implementations of the cartridge 200 may be designed to be used a limited number of times, after which at least a portion of the cartridge 200 must be replaced. To this end, the cartridge 200 (according to any implementation) may include a radiofrequency identification tag coupled to the housing (not shown) which may be read by the console 100 or another suitable device. The tag may contain usage data, such as a permitted number of uses of the cartridge 200. Similarly, in implementations where the detection block 250 is removable, the detection block 250 may include its own radiofrequency identification tag containing similar information that may be read by the console 100 or other device. In one example, the cartridge 200 is designed to be used 10 times, while the detection block 250 is meant to be used once. Based on information stored on the tag(s) and read by the console 100, the console 100 may be configured to authenticate the cartridge 200 and/or detection block 250 to be used. [0093] Referring to FIG. 19, a method 400 of controlling use of the cartridge 200 is shown. The method 400 may be earned out by the controller 42 or other computing device, and various prompts included in the method 400 may be presented on the display 52, 53 or other display device. That said, the method 400 is described herein as being carried out by the controller 42 and with the display 52 for brevity and clarity. At step 404, the method 400 begins when the user indicates that the current use of the cartridge 200 has completed, such as by pressing an end procedure button on the display 52. Once the controller 42 determines that the current use of the cartridge 200 is complete, the method 400 continues to step 408.
[0094] At step 408, the controller 42 determines a number of times that the cartridge 200 has been used (i.e., a number of uses corresponding to the cartridge 200), such as by reading the tag coupled to the cartridge 200. The controller 42 then compares the number of uses to a predetermined number, such as a permitted number of uses of the cartridge 200, to determine if the number of uses has reached the predetermined number. If so, the method 400 continues to step 410. At step 410, a notification is triggered to inform the user that the cartridge 200 has reached the reuse limit, such as by providing the notification on the display 52 informing the user that the cartridge 200 cannot be sufficiently cleaned for reuse due to the number of uses exceeding the predetermined number. Subsequently, the method 400 continues to step 448, at which point the user is prompted to remove the cartridge 200 from the console 100 and dispose of the cartridge 200. The prompt may also suggest or require disposing of the tubing 36 and/or the filter(s) 350. The method 400 then concludes after step 448.
[0095] Referring back to step 408, the method continues to step 412 if the number of uses associated with the cartridge 200 is below the predetermined number. At step 412, the controller 42 asks the user if reusing the cartridge 200 is desired, such as by causing the display 52 to show a yes/no option which accepts user input. If not, the method continues to step 448. If the user does want to reuse the cartridge 200, however, the method 400 continues to step 416. Overall, steps 416 through 444 represent a cleaning process. At step 416, the controller 42 prompts the user to suction cleaning fluid into the cartridge 200 and then proceeds to step 420. At step 420, the method 400 determines if the fluid level within the fluid reservoir 220 has reached a predetermined fluid level using the fluid level sensor(s) 270. If not, the method 400 loops back to step 416. Once the fluid level reaches the predetermined fluid level, the method continues to step 424. [0096] At step 424, the controller 42 causes the console 100 to switch the cartridge 200 into the purge mode so that fluid begins leaving the fluid reservoir 220. At step 428, the fluid being purged from the cartridge 200 passes through the detection block 250 and is analyzed by the console 100 (e.g., by the sensor assembly 120). The method then continues to step 432.
[0097] At step 432, the controller 42 determines the characteristics of the fluid flowing through the detection block 250 in order to determine if the fluid indicates that the cartridge 200 is adequately clean. If not, the method 400 moves to step 436, at which point an iteration counter may be incremented. The method continues to step 440 after step 436, and the counter is compared to an iteration threshold to determine if the cleaning cycle (i.e. , steps 416 to 444) should be repeated. More specifically, the method 400 may be configured to cause the cartridge 200 to be cleaned/rinsed with cleaning fluid a set number of times. And if the cartridge 200 is still not clean after being cleaned/rinsed the set number of times, the controller 42 may assume that the cartridge 200 is not able to be sufficiently cleaned and should instead be disposed of (or a portion of the cartridge 200 should be disposed of). Thus, based on the comparison at step 440, the method 400 either continues to step 444 or loops back to step 416. If the method 400 has looped repeatedly such that the iteration counter is higher than the threshold, the method 400 moves to step 444. At step 444, the controller 42 triggers a notification to inform the user that the cartridge 200 is considered soiled and cannot be reused, such as causing the display 52 to show a pop-up notification. After the notification is triggered, the method continues to step 448. If, however, the iteration counter is below the threshold, the method loops back to 416 and the method 400 again reaches step 432. If, at step 432, the controller 42 determines that the fluid characteristics indicate that the cartridge 200 is adequately clean, the method 400 continues to step 434.
[0098] At step 434, the controller 42 prompts the user to remove and/or dispose of single-use features of, or used with, the cartridge 200, such as the suction tubing 36 and/or the detection block 250. In some implementations, the cartridge 200 is designed to be used with the external filter 350 which is meant to be disposed of after every use of the cartridge 200. Thus, in these implementations, the controller 42 may instruct the user to remove/dispose of the external filter 350 along with the tubing 36. As an example of step 434, the controller 42 may cause the display 52, 53 to show that the cartridge 200 is sufficiently clean based on step 432 and/or indicate on the display 52, 53 that the tubing 36 should be replaced with a replacement tubing. Instead of or additionally to the tubing 36, the controller 42 may also cause the display 52, 53 to indicate that the detection block 250 should be replaced with a replacement detection block. After step 434 or 448, the method 400 ends.
IV. Fluid Level Sensing Implementations
[0099] As described above, the cartridge 200 may include fluid level sensors 270 in communication with the controller 42, such as for the purpose of determining in which operating mode the cartridge 200 should be operating. In some implementations, the console 100 may include the fluid level sensors 270 instead of the cartridge 200 including the level sensors 270. The fluid level sensors 270 may be in electrical communication with the controller 42 in this implementation. This can help lower the complexity and cost of the cartridge 200. In such an implementation, the console 100 may include the fluid level sensors 270 within and/or adjacent to the cartridge receiver 110 such that the level sensors 270 are positioned adjacent to the first sidewall 212 and fluid reservoir 220 of the cartridge 200 when the cartridge 200 is seated within the cartridge receiver 110. For example, the fluid level sensors 270 may be capacitive sensors which capacitively detect the fluid level within the fluid reservoir 220 through the first sidewall 212.
[0100] Referring to FIGS. 20-24, various implementations of detecting a fluid level within the cartridge 200 are illustrated. As shown in FIG. 20, the cartridge 200 may include at least one fluid level sensor 270 coupled to the first sidewall 212 of the housing 210. In the illustrated implementation, the cartridge 200 includes a first fluid level sensor 272, a second fluid level sensor 274, and a third fluid level sensor 276, each being disposed on the first sidewall 212. Relative to a height of the first sidewall 212, the first fluid level sensor 272 may be disposed near a middle thereof. Further, the second sensor 274 may be disposed between the first sensor 272 and the base 211, and the third sensor 276 may be disposed between the first sensor 272 and the top 217. Each of the fluid level sensor(s) 270 may be a resistive sensor, a capacitive sensor, a conductive strip, or any suitable alternative. The fluid level sensor(s) 270 may be in communication with the controller 42 such that signals can be transmitted by the fluid level sensor(s) 270 to the controller 42. For example, the cartridge 200 may include an electronic connector coupled to the housing and configured to mate with another electronic connector coupled to the console 100 and in communication with the controller 42 such that fluid level sensor(s) 270 may send signals to and receive signals from the console 100. The fluid level scnsor(s) 270 may continuously detect the fluid level within the fluid reservoir 220. Alternatively, the sensor(s) 270 may periodically detect the fluid level at certain intervals or according to specific triggers.
[0101] According to the signals received from the fluid level sensor(s) 270, the controller 42 may know how full the fluid reservoir 220 of the cartridge 200 is at any given time. For example, if the first fluid level sensor 272 detects fluid, the fluid reservoir 220 may be considered to be at least half full. If the second fluid level sensor 274 detects fluid, but the other fluid level sensors 272, 276 do not detect fluid, the fluid reservoir 220 may be considered to be less than half full but not empty. If the third fluid level sensor 276 detects fluid, the fluid reservoir 220 may be considered to be at least mostly full. Based on the signals from the fluid level sensor(s) 270, the controller 42 may change the cartridge 200 between modes operation as described with reference to FIGS. 7-8 and 11-12 above.
[0102] In some cases, the fluid suctioned from the surgical site and into the cartridge 200 can become aerated as blood mixes with air during transport through the suction line. This aeration, as well as a high flow rate generated by the vacuum source 30, can generate significant quantities of foam within the fluid reservoir 220. This foam can act on the fluid level sensor(s) 270 (e.g., capacitive sensors) in the same way as fluid, which creates false level detection signals. Although antifoaming chemical agents exist, using these agents to reduce the foam within the cartridge 200 would add additional levels of complexity and cost to the system and may interfere with the accurate measurement of blood concentration if the chemical agents change the optical properties of the blood. This makes mechanical defoaming, such as by using a foam shield introduced below, more desirable for the purposes described herein. At the same time, it may be desirable to reduce the cost of the cartridge 200 by having the console 100 (i.e., not the cartridge 200) include the fluid level sensors 270. This may be desirable if, for example, the cartridge 200 is of limited use as described below. FIGS. 21-24 illustrate various optional features of the cartridge 200 that may help avoid false level detection and reduce cost of the cartridge 200.
[0103] In FIG. 21, the cartridge 200 includes a series of protrusions 215 extending from the first side wall 212 and into the fluid reservoir 220 that are configured to minimize bubbles/foam within the liquid medical waste (see also FIG. 23). In some implementations, the protrusions 215 may be arranged near the fluid level sensors 270 to prevent bubbles/foam from forming on and/or near the fluid level sensors 270 and improve the accuracy of the fluid level readings by the fluid level sensor(s) 270. To this end, the protrusions 215 may be implemented as different shapes, such as spikes or other suitable shapes. At the same time, at least some of the protrusions 215 may extend all the way from the first sidewall 212 to the second/third sidewall 214, 216 (depending on which sidewalls 212, 214, 216 define the fluid reservoir 220 in the implementation of the cartridge 200) so as to extend across the entirety of the fluid reservoir 220. In this case, the protrusions 215 may act as stiffening members that prevent the sidewalls 212, 214, 216 from flexing inward as suction is drawn on the cartridge 200.
[0104] Additionally or alternatively, the cartridge 200 may include a foam shield 290 within the fluid reservoir 220 and arranged such that fluid within the shield 290 is aligned with the fluid level sensors 270 of the console 100 when the cartridge 200 is seated within the cartridge receiver 110. As foam can cause false level detection signals, especially for capacitive sensors, the foam shield 290 is meant to reduce the amount of foam that can be present near the fluid level sensors 270. To accomplish this, the foam shield 290 includes an upper outer barrier 291, an upper inner barrier 292, a lower barrier 293, a first side barrier 294, and a second side barrier 295. Each of the barriers 291, 292, 293, 294, 295 may be protrusions extending from one side of the fluid reservoir 220 to the other, such as between the first sidewall 212 and the second or third sidewall 214, 216. In the illustrated implementation, the second side barrier 295 is positioned closer to the front of the housing 210 (z.e., closer to the inlet 222) than the rest of the banders 291, 292, 293, 294, while the first side bander 294 is positioned closer to a rear of the housing (z.e., furthest from the inlet 222) that the remaining banders 291, 292, 293, 295. The upper barriers 291, 292, which may be v-shaped and contoured to one another like in the illustrated implementation, define a channel 296, and the lower barrier 293 defines a lower inlet opening 297 along with the second sidewall 295. The channel 296 includes a channel inlet 298 and a channel outlet 299. The channel inlet 298 may be vertically aligned with the lower inlet opening 297 and/or horizontally aligned in elevation with the channel outlet 299. At the same time, the channel 296 may be sloped upwards, like the v-shaped channel of the illustrated implementation, to require the fluid to be drawn up the slope when traversing the channel 296. Requiring the fluid to be drawn up the slope when traversing the channel 296 delays the foam from entering the foam shield 290 when the fluid level within the fluid reservoir 220 changes. It is also contemplated to form the channel 296 as a downward facing parabola or other shape. That said, so long as the channel outlet 299 is lower than the highest point of the channel 296, the amount of foam drawn into the foam shield 290 is reduced because the fluid level must reach a lower level before the foam on top of the fluid reaches the outlet 299. The lower inlet opening 297 may be positioned closest to the front of the housing 210 compared to the rest of the openings 298, 299, and the channel outlet opening 299 may be positioned closest to the rear of the housing 210 compared to the other openings 297, 298. Further, the inner upper barrier 292, the lower barrier 293, and the side barriers 294, 295 together define a void 300 in fluid communication with the channel inlet 298 and the lower inlet opening 297. In the illustrated implementation, the void 300 is pentagonal, but other shapes are contemplated.
[0105] The functionality of the foam shield 290 is shown in FIGS. 22A-22F. Starting with FIG. 22A, fluid begins entering the void 300 via the lower inlet opening 297 as the fluid level rises within the fluid reservoir 220. Air AR present within the void 300 prior to filling is pushed into the channel 296 through the channel inlet 298, and out through the channel 296 through the channel outlet 299. The lower inlet opening 297 may be designed as a small opening so that foam can only enter the void 300 at the staid of the fill and is minimized once the fluid level reaches the lower inlet opening 297. Similarly, the lower barrier 293 may also be angled relative to the remainder of the housing 210 (i.e., ramped) to decrease the tendency for foam to enter the void 300 due to the higher viscosity of blood compared to foam. Although not shown in the figures, the channel 296 may include features to cause bubbles included in the foam to expand and burst while traversing the channel 296. As shown in FIG. 22B, fluid continues filling of the void 300 until the fluid level meets the channel inlet 298, at which point some remaining air AR is trapped near a top of the void 300. By trapping the air AR near the top of the void 300, surface tension between the fluid and the top of the void 300 is reduced or avoided, and fluid may more easily leave the void 300 through the inlet 297.
[0106] FIGS. 22C-22F depict decreasing fluid levels within the fluid reservoir 220. Beginning with FIG. 22C, foam FO is drawn into the channel outlet 299 as the fluid level drops below the channel 296. More specifically, when the fluid level drops during purge mode, the fluid FL passes below the channel outlet 299 and any foam FO present on the surface of the fluid FL may be pulled into the channel 296 as the foam shield 290 begins to empty through the lower inlet opening 297. Some fluid FL may also be drawn into the foam shield 290 at the same time. Looking to FIG. 22D, the fluid level within the void 300 is stabilized by the design of the foam shield 290 and is delayed from leaving the void 300 until the fluid level outside of the foam shield 290 reaches a predetermined fluid level. Afterwards, air AR and foam FO replaces the fluid FL within the void 300 (see FIG. 22E) as the fluid level decreases, and air AR replace the foam FO (see FIG. 22F), as the fluid level decreases further. Since most of the foam passes over the foam shield 290 rather than being drawn into the void 300, the amount of foam that may end up in fornt of the fluid level sensor 270 is reduced, and false fluid level readings are minimised. Any foam that remains in the channel after emptying will then be pushed out on the next fill cycle (i.e., once the cartridge 200 has been moved back into recirculation mode).
[0107] Although not shown in the figures, the cartridge 200 may include multiple foam shields 290, similar to how the cartridge 200 implementation shown in FIG. 20 includes three fluid level sensors 270. Like the cartridge 200 of FIG. 20, the plurality of foam shields 290 may be disposed at various positions relative to the height of the cartridge. This way, for example, a first capacitive sensor of the console 100 can determine whether fluid is disposed within a first foam shield which is disposed near the middle of the first sidewall 212. Continuing the example, second and third capacitive sensors can determine whether fluid is within a second and third foam shield, respectively. To provide similar functionality as the fluid level sensors 272, 274, 276 of FIG. 20, the second foam shield can be disposed between the first foam shield and the base 211, while the third foam shield can be disposed between the first foam shield and the top 217. In doing so, fluid within the second foam shield may indicate that the fluid reservoir 220 is at least partially filled with fluid (e.g., filled to at least 30% capacity), fluid within the first foam shield may indicate that the reservoir 220 is at least half filled with fluid, and fluid within the third foam shield may indicate that the reservoir 220 is mostly filled with fluid (e.g., filled to at least 70% capacity). Additionally, the fluid level measurements may be more reliable for the reasons described above with respect to the foam shield 290.
[0108] Another implementation of detecting fluid levels within the fluid reservoir 220 is shown in FIGS. 23 and 24. In this implementation, the cartridge 200 includes a float assembly 280 disposed within the fluid reservoir 220. The float assembly 280 may include a float casing 281, a pivot 282 pivotably coupling the float casing 281 to the housing 210, and a recess 283 defined by the float casing 281 and configured to receive a magnetic element (not shown). The float casing 281 is designed to be buoyant and rotate about the pivot 282 as the fluid level within the reservoir 220 increases. To this end, the float casing 281 may include a first lateral sidewall 284 and a second lateral sidewall 285 which arc planar, oriented parallel to one another 284, 285, and separated by an endwall 286. The first lateral sidewall 284 may be positioned adjacent the first sidewall 212 (not shown in FIG. 23) and define the recess 283 which is configured to receive and retain the magnetic element, such as via a press fit arrangement. As shown in the figures, the endwall 286 may include an arcuate portion and two flat portions. The walls 284, 285, 286 may together define a hollow space (not shown) within the casing 281. Further, the float casing 281 may also include at least one stiffening member extending between the lateral sidewalls 284, 285 to maintain the shape of the casing 281. The casing 281 is illustrated as being substantially disc-shaped, but other shapes are contemplated.
[0109] As mentioned above, the float assembly 280 is configured to rotate about the pivot 282 as the fluid level within the reservoir 220 increases. When the float assembly 280 rotates, the magnetic element within the recess 283 travels in a sweeping/arcuate motion. To determine fluid level in this implementation, the fluid level sensors 270 may be electromagnetic sensors, such as reed switches, configured to sense the presence of the magnetic element. More specifically, the console 100 may include the first fluid level sensor 272 and the second fluid level sensor 274, each implemented as reed switches. In other implementations, the cartridge 200 may include the level sensors 270, 272, 274 coupled to the housing 210. In either case, the magnetic element rises as the float assembly 280 rotates, and the fluid level can be determined based on which of the first/second sensors 272, 274 detect the magnetic element.
[0110] The float assembly 280 may include additional features to increase the efficacy of the float assembly 280 in determining fluid level within the fluid reservoir 220. In some implementations, the float assembly 280 may include protrusions extending outwardly from the float casing 281 and configured to break surface tension of the fluid within the reservoir 220. More specifically, a suction force may form between the housing 210 and the lateral sidewalls 284, 285 when fluid is present between the two 210, 284/285 due to the surface tension of the fluid. The protrusions may include elongate ridge(s) 287 extending outwardly from at least one of the first lateral sidewall 284 and the second lateral sidewall 285, and/or conical/dome- shaped geometries 288 extending outwardly from the endwall 286. The elongate ridges 287 may be arcuate in a direction of a sweeping motion of the float casing 281 about the pivot 282. In other words, the ridges 287 may be shaped as portions of concentric circles that are centered on the pivot 282 but have different radii. As for the geometries 288 extending from the endwall 286, these protrusions prevent the cndwall 286 from sticking to the other portions of the housing 210 (e.g., the base 211) by breaking the surface tension of fluid between the housing 210 and the endwall 286. Both elements 287, 288 increase the accuracy of fluid level detection using the float assembly 280. For example, the float assembly 280 may provide a lower-than-actual fluid level if the flat portion of the endwall 286 were to stick to the bottom of the cartridge 200. At the same time, the float assembly 280 may provide a higher-than actual fluid level if the arcuate portion of the endwall 286 sticks to the side of the cartridge 200. By preventing the float assembly 280 from sticking to the bottom/side of the cartridge 200 with the geometries 288, the accuracy of the fluid level detection is increased.
V. The Sensor Assembly
[0111] Referring to FIGS. 25 and 26, the sensor assembly 120 is shown without the rest of the console 100. As shown in FIG. 25, the sensor assembly 120 includes an upper sensor bracket 130 and a lower sensor bracket 140. These upper and lower sensor brackets 130, 140 are arranged relative to one another such that the detection block 250 of the cartridge 200 rests between the sensor brackets 130, 140 when the cartridge 200 is seated within the cartridge receiver 110 of the console 100. The upper sensor bracket 130 includes an upper mount 132 mounted within the cartridge receiver 110 and an upper sensor head 134 movably coupled to the upper mount 132. The lower sensor bracket 140 includes a lower mount 142 mounted within the cartridge receiver 110 and a lower sensor head 144 movably coupled to the lower mount 142. Once the cartridge 200 is inserted into the cartridge receiver 110 of the console, the detection block 250 rests between the upper and lower sensor brackets 130, 140 such that the detection windows 254 line up between the upper and lower sensor heads 134, 144.
[0112] Various arrangements of the optical emitter 122 and optical detector 124 are contemplated. The upper sensor head 134 may include the optical emitter 122 and the lower sensor head 144 may include the optical detector 124 as shown in FIG. 25. In other implementations, the upper sensor head 134 may include the optical detector 124 and the lower sensor head 144 may include the optical emitter 122. In further implementations, the sensor heads 134, 144 may each include the optical emitter 122 and the optical detector 124 such that there are two emitter-detector pairs, one emitter 122 transmitting light from the upper sensor head 134 to the lower sensor head 144, and the other emitter 122 transmitting light from the lower sensor head 144 to the upper sensor 134. Regardless of implementation, light is transmitted from the optical emitter(s) 122, through one detection window 254 of the detection block 250, through the fluid flowing along the fluid channel 252, out through the other detection window(s) 254, and to the optical detector(s) 124.
[0113] The sensor assembly 120 may also include a lateral sensor bracket 150 which has a lateral mount 152 mounted within the cartridge receiver and a lateral sensor head 154 movably coupled to the lateral mount 152. The lateral sensor head 154 is arranged such that the emitter(s) 122, 124 disposed therein line up with the detection window 254 of the detection block 250 when the cartridge 200 is within the cartridge receiver 110 of the console 100. In some implementations, the lateral sensor head 154 includes the optical detector 124. In this implementation, one of the upper or lower sensor heads 134, 144 may also include the optical detector. For example, the upper sensor head 144 may include the optical emitter 122, while the lower and lateral sensor heads 134, 154 each include respective optical detectors 124. As light is transmitted from the optical emitter 122 disposed within the upper sensor head 144, it will pass into one detection window 254 and out the other two detection windows 254 after passing through the fluid within the channel 252. In this example, the optical detector 124 of the lower sensor head 134 may receive a light signal which corresponds to the light emitted by the optical emitter 122 as attenuated by the fluid disposed between the detection windows 254. Further, the optical detector 124 of the lateral sensor head 154 may receive a scattered light signal which corresponds to the light emitted by the optical emitter 122 as scattered by the fluid disposed between the detection windows 254.
[0114] The detection block 250 may have a thickness, as defined by the distance between the upper and lower surfaces 257, 258, which largely matches the distance between the upper and lower sensor brackets 130, 140. For example, the detection block may have a thickness of 1.0 centimeters. That being said, in order to ensure that the sensor assembly 120 is able to accurately characterize the fluid flowing through the fluid channel 252 of the detection block 250, at least one of the sensor brackets 130, 140, 150 may be biased towards the respective surface 257, 258, 259 of the detection block 250. To that end, as shown in FIG. 26, the sensor assembly 120 may include at least one biasing member 170 disposed near the sensor bracket(s) 130, 140, 150. For example, the sensor assembly 120 may include at least one of an upper sensor biasing member 171 disposed between the upper mount 132 and the upper sensor head 134, a lower biasing member 172 disposed between the lower mount 142 and the lower sensor head 144, and/or a lateral biasing member 173 disposed between the lateral mount 152 and the lateral sensor head 154. In any case, the biasing member(s) 171, 172, 173 are configured to bias the respective sensor head 134, 144, 154 away from the respective mount 132, 142, 152 and toward the detection block 250.
[0115] More specifically, the upper biasing member 171 may bias the upper sensor head 134 into direct contact with the upper surface 257 of the detection block 250 such that optical signals sent to/from the upper sensor head 134 need not travel far between the detection window 254 of the upper surface 257 and the optical emitter-detector 122, 124 disposed within the upper sensor head 134. Additionally or alternatively, the lower biasing member 172 may bias the lower sensor head 144 into direct contact with the lower surface 258 of the detection block 250 such that optical signals sent to/from the lower sensor head 144 need not travel far between the detection window 254 of the lower surface 258 and the optical emitter-detector 122, 124 disposed within the lower sensor head 144. Similarly, the lateral biasing member 173 may bias the lateral sensor head 154 into direct contact with the lateral surface 259 of the detection block 250 such that optical signals sent to/from the lateral sensor head 154 need not travel far between the detection window 254 of the lateral surface 259 and the optical emitter/detector 122, 124 disposed within the lateral sensor head 154.
[0116] In order to ensure direct contact between the detection block 250 and the upper/lower sensor heads 134, 144, the biasing members 171, 172 may be configured to bias the sensor heads 134, 144 in multiple degrees of freedom. In other words, the biasing member 171 may provide a translational biasing force which urges the sensor heads 134, 144 towards the respective detection windows 254, as well as a rotational biasing force to accommodate any difference in rotation between the biasing member 171, 172 and the sensor head 134, 144. In some implementations, the biasing members 171, 172 include at least one of a collinear joint 175 which allows the biasing member to provide the translational biasing force and a revolute joint 176 which allows the biasing member 170 to provide the rotational biasing force. VI. Estimating Blood Loss
[0117] Referring more generally to the figures, a number of methods of estimating blood loss are possible with the waste collection system 20. In each of the methods, the cartridge 200 is inserted into the cartridge receiver 110 of the console 100 before the method begins.
[0118] According to one method, the method begins with drawing fluid through the inlet fitting 222, such as by the suction tool 40 or other vacuum source. Once fluid is drawn through the inlet fitting 222, the fluid drops into the fluid reservoir 220. With fluid now in the fluid reservoir 220, the peristaltic pump 114 is operated by the console 100 (e.g., activated by the controller 42) to draw the fluid from the fluid reservoir 220, and into the detection block 250 such that the fluid flows between the detection windows 254. As fluid flows between detection windows 254, the sensor assembly 120 is utilized by the system 20 e.g., by the controller 42) to detect a blood characteristic of the fluid, such as a concentration of blood in the fluid. Based on an analysis of the blood characteristic of the fluid, the eBL is determined.
[0119] The fluid may be analyzed by the sensor assembly 120 while the cartridge 200 is in any of the purge, recirculation, and fill modes. For example, continuing with the above method, the cartridge 200 may be set to the purge mode. In the purge mode, the fluid is drawn from the detection block 250, through the third conduit 246 (see FIGS. 7 and 11), through the first conduit 244, and finally out of the cartridge 200 via the first outlet fitting 226. In another example continuing the above method, the cartridge 200 may be set to the recirculation mode. In the recirculation mode, the fluid is drawn from the detection block 250, through the third conduit 246 (see FIGS. 8 and 12), through the second conduit 245, and back into the fluid reservoir 220.
[0120] During use (e.g., during the above method), the cartridge 200 may be configured to switch between modes based on the needs of the user and/or characteristics of the fluid. In any of these cases, the method above may further include switching the operating mode of the cartridge 200. For example, where the cartridge 200 is operating in the recirculation mode, the method may include changing from the recirculation mode to the purge mode. To accomplish this, the second actuator 161 may be actuated to close the second conduit 245 and prevent the fluid from flowing through the same. At the same time (or shortly before/after), the first actuator 160 may be actuated to open the first conduit 244 and permit the fluid to flow through the first conduit 244 and out of the cartridge 200 via the first outlet fitting 230. Alternatively, where the cartridge 200 is operating the purge mode, the method may include changing from the purge mode to the recirculation mode. To that end, the first actuator 160 may be actuated to close the first conduit 244 and prevent the fluid from flowing through the same. At approximately the same time, the second actuator 161 may be actuated to open the second conduit 245 and permit the fluid to flow through the second conduit 245 and back into the fluid reservoir 220. The method may include switching the cartridge 200 between the purge mode and the recirculation mode based on signals received from the fluid sensor(s) 270 as described above.
[0121] In some implementations, the method may include analyzing the fluid flowing within the detection block 250 only when the cartridge 200 is in the purge mode. This may be advantageous where an estimation of a volume of the fluid is desired or required. For example, the eBL may be calculated by determining a concentration of blood (or other characteristic) within the fluid by analyzing the fluid within the detection block 250. Additionally, the system 20 may determine a purged volume of fluid corresponding to the amount of fluid that has been expelled by the cartridge via the second outlet fitting 230. The volume of fluid can then be combined (e.g., multiplied) with the concentration of blood to estimate the blood loss. To that end, the volume of fluid may be determined in different ways. For example, the volume may be calculated based on the amount of fluid expelled from the cartridge 200 and into the waste container 26. In such an example, the camera (e.g., a camera disposed within the cart 22 and/or external thereto) may be used to capture an image of the waste container 26 to determine the purge volume. In another example, the volume may be calculated based on characteristics of the peristaltic pump 114, such as an average flow rate parameter of the peristaltic pump 114. In this example, the average flow rate parameter (e.g., an average volumetric flow rate) may be multiplied by the amount of time that the peristaltic pump 114 has been active (e.g., number of rotations of the pump head) in order to determine the total volume of fluid that has been purged from the cartridge 200. In yet another example, a flow sensor can be used to estimate the volumetric flow rate within the cartridge 200 or the total volume of fluid that has been purged from the cartridge 200. The flow sensor may be an ultrasonic flow sensor, an optical flow sensor, or any suitable alternative. Further, the flow sensor may be coupled to any one of the conduits 244, 245, 246, or the fluid channel 252 of the detection block 250. Even further, where the flow sensor is an optical flow sensor, the optical flow sensor may be positioned adjacent to the detection window 254. In this case, the optical flow sensor may be included in the sensor assembly 120 of the console 100. And in some cases, the detection block 250 may include a second set of detection windows positioned about the channel 252, and the optical flow sensor may be positioned adjacent to the second set of detection windows.
[0122] The method may further include displaying details associated with the fluid passing through the cartridge 200 on the display 52, 53. For example, the method may include causing the display(s) 52, 53 to display at least one of: the eBL, the volumetric flow rate, the blood concentration, the operating mode of the cartridge 200, the volume of fluid within the waste container 26, and/or any other metric disclosed herein. Furthermore, the method may include displaying a high fluid level warning on the display(s) 52, 53 based on signals from the fluid level sensor(s) 270. For example, the high fluid level warning may be triggered based on the third fluid level sensor 276 detecting a high fluid level.
[0123] Based on experimental use of the cartridge 200, it was found that the optical properties of blood cause both light transmission and scatter to change dramatically as the concentration of blood (mixed with saline or water) increases. Referring to FIG. 27A, a graphed response curve correlating the detected optical signal to the estimated blood concentration is shown. At high concentrations (60%+), the response is relatively flat. In practice, this means that it is often too difficult to distinguish between, for example, 70% and 90% blood which makes the overall quantification of blood loss much less accurate. Since optical signals are measured to estimate concentration, it is advantageous if the optical signals, in both green and infrared channels, change as much as possible as concentration changes. To achieve this, an amplifier that can deal with a broad range of input voltages can be used. More specifically, it would be advantageous if the amplifier had the ability to distinguish between high concentration blood samples where there is little light passing through while also avoiding the case where the amplifier saturates and cannot measure low concentration blood samples meaningfully. Thus, it was proposed that a logarithmic amplifier could be used to improve the accuracy of the measurement system.
[0124] Referring to FIGS. 27B and 28, an ideal response curve is illustrated along with an exemplary logarithmic amplifier which can be used to change the response curve from the curve shown in FIG. 27A into the curve shown in FIG. 27B. Logarithmic amplifiers are typically used in audio and radar’ applications where the inputs and outputs range across several orders of magnitude (normally measured in decibels). The output of the logarithmic amplifier is proportional to the logarithm of the input, and the amplifier achieve this desired transfer function by using a non-linear component, often a diode, placed in the feedback loop of the amplifier (see FIG. 28). Following on from some initial testing, it was shown that using a log amplifier, optionally in series with a non-inverting amplifier, increased the difference in the amplified optical signals as blood concentration changed (see FIG 27B). The response is much less flat at the higher concentrations, and this led to more accurate differentiation between these samples without saturating at the low concentrations. In light of the results of testing, it is further contemplated to add the logarithmic amplifier to the sensor assembly 120 of any implementation of the cartridge 200 described above.
[0125] In one implementation, the sensor assembly 120 includes a signal conditioning circuit to take advantage of the finding described in this section. Referring back to FIG. 25, the signal conditioning circuit may be in electronic communication with the optical detector(s) 124 and may include a logarithmic amplifier and a non-inverting amplifier in series with one another. This way, the response (output) of the optical detector(s) 124 can be conditioned by the signal conditioning circuit (/.<?.. by the logarithmic amplifier and the noninverting amplifier) to increase the accuracy of the sensor assembly 120 in determining characteristics of the fluid, such as the blood concentration of the fluid. Although the implementation has been described as including a non-inverting amplifier, other types of amplifiers are contemplated. For example, the signal conditioning circuit may include the logarithmic amplifier in series with an inverting amplifier.
[0126] Several implementations have been discussed in the foregoing description. However, the implementations discussed herein are not intended to be exhaustive or limit the invention to any particular form. Modifications and variations are possible in light of the above teachings and may be practiced otherwise than as specifically described. In one example, the methods disclosed herein may be performed on a waste container that is not disposed on a mobile cart. In another example, the methods may be used to estimate a concentration and an amount of a non-blood component within the waste container 26, such as saline, ascites, bile, irrigating fluids, saliva, gastric fluid, mucus, pleural fluid, interstitial fluid, urine, fecal matter, or the like. In yet another example, the medical waste collection system 20 may communicate with other systems to form a fluid management ecosystem for generating a substantially comprehensive estimate of extracorporeal blood volume, total blood loss, patient euvolemia status, or the like. [0127] Additional inventive aspects of the present disclosure are appreciated with reference to the following exemplary clauses.
[0128] Clause 1 - A cartridge for estimating blood loss within liquid medical waste, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; an outlet fitting coupled to the housing and configured to be removably coupled with an outlet suction tube; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; and conduits disposed within or formed with the housing, wherein flow paths defined by the conduits are configured to be selectively controlled to provide for (i) a recirculation mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, and into the fluid reservoir, and (ii) a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, and through the first outlet fitting.
[0129] Clause 2 - A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly, a first actuator, and a second actuator, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; an outlet fitting coupled to the housing and configured to be removably coupled with an outlet suction tube; and a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; and a conduit assembly comprising a first conduit, a second conduit, a third conduit, and a fourth conduit, wherein the conduit assembly is configured to interface with the first and second actuators of the console to selectively move the cartridge between (i) a fill mode in which air is drawn from the fluid reservoir, through the second conduit, through the fourth conduit, and through the outlet fitting, and fluid is drawn through the inlet fitting and into the fluid reservoir, and (ii) a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the first conduit, through the fourth conduit, and through the first outlet fitting.
[0130] Clause 3 - The cartridge of clause 2, further comprising: a first weir arranged between the second conduit and the fluid reservoir; and a second weir arranged between the first conduit and the fourth conduit, wherein the weirs are configured to be acted on by the actuators of the console to selectively move the cartridge between the fill mode and the purge mode.
[0131] Clause 4 - The cartridge of clause 2 or 3, wherein the cartridge is configured to be in the fill mode when the first weir is not actuated and the second weir is actuated, and wherein the second weir blocks fluid flow between the first conduit and the fourth conduit when depressed.
[0132] Clause 5 - The cartridge of any one of clauses 2-4, wherein the cartridge is configured to be in the purge mode when the first weir is actuated and the second weir is not actuated, and wherein the first weir blocks fluid flow between the second conduit and the fluid reservoir when depressed.
[0133] Clause 6 - The cartridge of any one of clauses 2-5, wherein the third conduit is coupled to an outlet of the detection block, wherein the first conduit is coupled to the third conduit, wherein the fourth conduit is coupled to the first conduit and the second conduit, and the second conduit is coupled to the fourth conduit.
[0134] Clause 7 - The cartridge of any one of clauses 2-6, further comprising a flow sensor coupled to the third conduit and configured to estimate a flow rate of liquid medical waste flowing within the third conduit.
[0135] Clause 8 - The cartridge of any one of clauses 2-7, wherein at least one of the first conduit, the second conduit, the third conduit, and the fourth conduit are defined by the housing of the cartridge.
[0136] Clause 9 - A system comprising: the cartridge of any one of clauses 2-8; a console comprising a flow sensor, a controller, and a display, wherein the controller is configured to: cause an external vacuum source to draw the liquid medical waste into the fluid reservoir through the first suction tube and the inlet fitting, through the fluid channel, and through second outlet fitting; receive, from the flow sensor, data indicative of volumetric flow through the second outlet fitting; receive, from the optical detector, data indicative of blood concentration within the liquid medical waste; determine a quantity of blood based on the volumetric flow data and the blood concentration data; and output, on the display, the quantity of blood.
[0137] Clause 10 - The system of clause 11, wherein the flow sensor is one of an ultrasonic sensor, and a second optical detector.
[0138] Clause 11 - The system of clause 10 or 11, wherein the console is devoid of a peristaltic pump.
[0139] Clause 12 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is coupled to the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump to draw liquid medical waste from the fluid reservoir and through the detection window; detecting, with the sensor assembly, a blood characteristic of the liquid medical waste within or passing through the detection window; operating the peristaltic pump with the cartridge in a purge mode in which the liquid medical waste is directed through the conduit assembly and through the first outlet fitting; and estimating the blood loss based on an analysis of the blood characteristic of the liquid medical waste.
[0140] Clause 13 - The method of clause 12, further comprising further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed through the conduit assembly and into the fluid reservoir.
[0141] Clause 14 - The method of clause 13, further comprising moving the cartridge from the purge mode to the recirculation mode by: actuating the first actuator to prevent flow of the liquid medical waste through a first conduit of the conduit assembly; and actuating the second actuator to permit the flow of the liquid medical waste through a second conduit of the conduit assembly and into the fluid reservoir.
[0142] Clause 15 - The method of clause 14, further comprising moving the cartridge from the recirculation mode to the purge mode by: actuating the second actuator to prevent the flow of the liquid medical waste through the second conduit of the conduit assembly; and actuating the first actuator to permit the flow of the liquid medical waste through the first conduit of the conduit assembly and through the first outlet fitting.
[0143] Clause 16 - The method of clause 14 or 15, wherein the first and second actuators are first and second pistons, wherein the step of actuating the first actuator further comprises moving the first piston to pinch or release an exposed portions of the first conduit, and wherein the step of actuating the second actuator further comprises moving the second piston to pinch or release an exposed portions of the second conduit.
[0144] Clause 17 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump to draw liquid medical waste from the fluid reservoir and through the detection window; detecting, with the sensor assembly, a blood characteristic of the liquid medical waste within or passing through the detection window; further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed through the conduit assembly and into the fluid reservoir; and not providing an output of analysis of the blood characteristic of the liquid medical waste with the cartridge in the recirculation mode.
[0145] Clause 18 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump to draw the liquid medical waste from the fluid reservoir and through the sensor assembly and detection window; detecting, with the sensor assembly, a blood characteristic of the liquid medical waste within or passing through the detection window; and further operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and into the fluid reservoir without providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the recirculation mode.
[0146] Clause 19 - The method of clause 18, further comprising analyzing homogeneity of the blood characteristic of the liquid medical waste with the cartridge in the recirculation mode.
[0147] Clause 20 - The method of clause 19, further comprising moving the cartridge from the recirculation mode to a purge mode if the homogeneity is above a predetermined threshold. [0148] Clause 21 - The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
[0149] Clause 22 - The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
[0150] Clause 23 - The method of clause 19 or 20, further comprising: moving the cartridge from the recirculation mode to the purge mode if the homogeneity is above a predetermined threshold; operating the peristaltic pump with the cartridge in the purge mode in which the liquid medical waste is directed from the sensor assembly, through the conduit assembly, and through the first outlet fitting; and providing an output of analysis of the blood characteristic of the liquid medical waste while the cartridge is in the purge mode.
[0151] Clause 24 - The method of any one of clauses 18-24, further comprising determining a purged volume of the liquid medical waste purged from the cartridge in the purge mode, wherein the step of estimating the blood loss is based on the blood characteristic and the purged volume.
[0152] Clause 25 - The method of clause 25, wherein the step of determining the purged volume is based on the blood characteristics and operation of the peristaltic pump.
[0153] Clause 26 - The method of clause 25, wherein the step of determining the purged volume is based on an external volume determination means.
[0154] Clause 27 - The method of any one of clauses 18-25, wherein the cartridge includes at least one fluid level sensor, the method further comprising moving the cartridge between the purge mode and the recirculation mode based on a signal received from the at least one fluid level sensor. [0155] Clause 28 - A method of estimating blood loss with a system including a console including a sensor assembly, first and second actuators, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, a first outlet fitting, and a fluid level sensor, the method comprising: operating the peristaltic pump with the cartridge in a recirculation mode in which liquid medical waste is drawn from the fluid reservoir, through the detection window, through the conduit assembly, and into the fluid reservoir; detecting, with the fluid level sensor, a fluid level of the liquid medical waste within the fluid reservoir; actuating, with the controller, the first and second actuators of the console to move the cartridge from the recirculation mode to a purge mode in which the liquid medical waste is directed through the conduit assembly and through the first outlet fitting; and estimating blood loss based on an analysis of the liquid medical waste in the purge mode.
[0156] Clause 29 - The method of clause 28, wherein the cartridge further includes a second fluid level sensor positioned near a base of the cartridge, the method further comprising moving, with the controller, the cartridge from the purge mode to the recirculation based on the second fluid level sensor detecting a low fluid level.
[0157] Clause 30 - The method of clause 29, wherein the cartridge further includes a third fluid level sensor positioned near a top of the cartridge, the method further comprising displaying, on a display of the console, a high fluid level warning based on the third fluid level sensor detecting a high fluid level.
[0158] Clause 31 - The method of clause 28, wherein the fluid level sensor is a conductive strip.
[0159] Clause 32 - The method of any one of clauses 18-32, wherein the vacuum source is an external vacuum source disposed on a medical waste collection system.
[0160] Clause 33 - A cartridge configured to be inserted into a console for estimating blood loss within liquid medical waste, wherein the console includes a sensor assembly, first and second actuators, a peristaltic pump, and a controller, the cartridge comprising: a housing defining a fluid reservoir; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; a first outlet fitting coupled to the housing and configured to be removably coupled with a first outlet suction tube; a conduit assembly; and at least one fluid level sensor, the at least one fluid level sensor including at least one fluid level sensor coupled to the housing and disposed within the fluid reservoir, wherein the at least one fluid level sensor is configured to be arranged in electronic communication with the controller to provide for the cartridge being selectively moved between a purge mode and a recirculation mode based on signals from the at least one fluid level sensor.
[0161] Clause 34 - The cartridge of clause 33, further comprising a protrusion positioned adjacent each of the at least one fluid level sensor, wherein the protrusions are configured to minimize bubbles within the liquid medical waste; and, optionally, wherein the protrusions are spikes.
[0162] Clause 35 - The cartridge of clause 33 or 34, wherein the at least one fluid level sensor is one of a resistive sensor and a capacitive sensor.
[0163] Clause 36 - The cartridge of clause 35, wherein the at least one fluid level sensor comprises a conductive strip.
[0164] Clause 37 - A cartridge configured to be inserted into a console for quantifying blood within liquid medical waste, wherein the console includes a capacitive sensor, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a void space configured to be aligned with the capacitive sensor of the console, wherein the barriers comprise an upper inner banner and an upper outer barrier defining a channel therebetween, and a lower barrier defining a lower inlet opening, wherein the channel is configured to permit egress of air or foam with the liquid medical waste entering the void space through the lower inlet opening. [0165] Clause 38 - The cartridge of clause 37, wherein the inner upper barrier further defines a channel inlet opening within the void space; and, optionally, wherein the channel inlet opening is vertically aligned with the lower inlet opening.
[0166] Clause 39 - The cartridge of clause 37 or 38, wherein the lower barrier is ramped.
[0167] Clause 40 - The cartridge of any one of clauses 37-39, wherein the inner upper barrier is ramped.
[0168] Clause 41 - The cartridge of clause 40, wherein the outer upper barrier is V- shaped and contoured to the inner upper barrier.
[0169] Clause 42 - The cartridge of any one of clauses 37-41, wherein the barriers further comprises a first side barrier extending between the outer upper barrier and the lower inlet opening.
[0170] Clause 43 - The cartridge of any one of clauses 37-42, wherein the outer upper barrier defines a channel outlet opening positioned external to the void space.
[0171] Clause 44 - The cartridge of any one of clauses 37-43, further comprising a second side barrier extending between the inner upper barrier and the lower barrier.
[0172] Clause 45 - A cartridge configured to be inserted into a console for quantifying blood within liquid medical waste, wherein the console includes a capacitive sensor, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a void space configured to be aligned with the capacitive sensor of the console, wherein the barriers define a lower inlet opening between the fluid reservoir and the void space, a channel, a channel inlet opening, a channel outlet between the void space from the channel, and a channel outlet opening between the channel and the fluid reservoir.
[0173] Clause 46 - The cartridge of clause 45, wherein the channel inlet opening is vertically aligned with the lower inlet opening. [0174] Clause 47 - The cartridge of clause 45 or 46, wherein the channel outlet opening is horizontally aligned in elevation with the channel inlet opening.
[0175] Clause 48 - The cartridge of any one of clauses 45-47, wherein the channel is disposed above the channel outlet opening such that air or foam with the liquid medical waste is drawn into the void space under influence of vacuum as the liquid medical waste is being drawn out of the void space through the lower inlet opening during purging of the cartridge.
[0176] Clause 49 - The cartridge of any one of clauses 45-48, wherein the barriers comprise a lower barrier, an upper inner barrier, and an outer inner barrier.
[0177] Clause 50 - The cartridge of clause 49, wherein the lower barrier is ramped.
[0178] Clause 51 - The cartridge of clause 49 or 50, wherein the inner upper barrier is V-shaped, and wherein the outer upper barrier is V-shaped and contoured to the inner upper barrier.
[0179] Clause 52 - The cartridge of any one of clauses 49-51, wherein the barriers further comprise: a first side barrier extending between the outer upper barrier and the lower inlet opening; and a second side barrier extending between the inner upper bander and the lower barrier.
[0180] Clause 53 - The cartridge of any one of clauses 37-52, wherein the housing comprises a front wall, a rear’ wall, and the opposing sidewalls, wherein the inlet fitting and the outlet fitting extend from the front wall, and wherein the lower inlet opening is positioned closest to the front wall relative of the void space.
[0181] Clause 54 - The cartridge of any one of clauses 37-53, wherein the void space is pentagonal.
[0182] Clause 55 - The cartridge of any one of clauses 37-54, wherein the capacitive sensor is a first capacitive sensor, wherein the console further includes a second capacitive sensor, wherein the plurality of barriers is a first plurality of barriers, wherein the void space is a first void space configured to be aligned with a first capacitive sensor of the console, wherein the first void space is defined at a first height relative to the fluid reservoir, and wherein the cartridge further comprises: a second plurality of barriers extending between opposing sidewalls of the fluid reservoir and defining a second void space configured to be aligned with a second capacitive sensor of the console, wherein the barriers define a lower inlet opening between the fluid reservoir and the second void space, a channel, a channel inlet opening, a channel outlet between the second void space from the channel, and a channel outlet opening between the channel and the fluid reservoir, wherein the second void space is defined at a second height relative to the fluid reservoir, the second height being different than the first height.
[0183] Clause 56 - A system comprising: the cartridge of any one of clauses 37-55, further comprising a detection window; a console comprising the capacitive sensor and a controller in electronic communication with the capacitive sensor, wherein the controller is configured to: cause the external vacuum source to draw the liquid medical waste into the fluid reservoir through the first suction tube and the inlet fitting; receive signals from the capacitive sensor; compare the signals against a predetermined threshold; and selectively actuate actuators of the console based on the signals exceeding a predetermined threshold, wherein the cartridge is moved from a recirculation mode to a purge mode in which the liquid medical waste is directed through the detection window and the outlet fitting and into the second suction tube.
[0184] Clause 57 - A cartridge configured for quantifying blood within liquid medical waste with a console including a capacitive sensor, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a float assembly disposed within the fluid reservoir, wherein the float assembly comprises a float casing, a pivot pivotably coupling the float casing to the housing, and a magnetic element coupled to the float casing.
[0185] Clause 58 - The cartridge of clause 57, wherein the float assembly further comprises stiffening members disposed within and extending between opposing sides of the float casing.
[0186] Clause 59 - The cartridge of clause 57 or 58, wherein the float casing comprises lateral sidewalls separated by an endwall, wherein one of the lateral sidewalls is slidably positioned adjacent to an outer sidewall of the housing, wherein the float casing defines a recess configured to receive the magnetic element; and optionally, wherein the magnetic element is retained within the recess via a press fit engagement.
[0187] Clause 60 - The cartridge of clause 59, wherein the lateral sidewalls are planar and oriented parallel to one another. [0188] Clause 61 - The cartridge of clause 59 or 60, wherein the endwall comprises an arcuate portion, and two flat portions.
[0189] Clause 62 - The cartridge of any one of clauses 57-61, wherein the float assembly further comprises protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste.
[0190] Clause 63 - The cartridge of clause 62, wherein the protrusions comprise conical or dome-shaped geometries; and, optionally, wherein the conical or dome-shaped geometries extend outwardly from the endwall of the float casing.
[0191] Clause 64 - The cartridge of clause 63, wherein the geometries include a first geometry and a second geometry, wherein the endwall comprises an arcuate portion and a flat portion, wherein the first geometry extends outwardly from the flat portion, and the second geometry extends outwardly from the arcuate portion.
[0192] Clause 65 - The cartridge of clause 62, wherein the protrusions comprise an elongate ridge extending outwardly from the lateral sidewalls; and, optionally, wherein the elongate ridge is arcuate in a direction of a sweeping motion of the float casing about the pivot.
[0193] Clause 66 - A cartridge configured for estimating blood within medical waste, the cartridge comprising: a housing defining a fluid reservoir; an inlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with a first suction tube; an outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the outlet fitting is configured to be coupled to a second suction tube operably coupled to an external vacuum source; and a float assembly disposed within the fluid reservoir, wherein the float assembly comprises a float casing comprising lateral sidewalls slidably positioned between opposing interior surfaces of the housing, an endwall extending between the lateral sidewalls, and protrusions extending outwardly from the float casing and configured to break surface tension of the liquid medical waste.
[0194] Clause 67 - The cartridge of clause 66, wherein the protrusions comprise conical or dome-shaped geometries; and, optionally, wherein the conical or dome-shaped geometries extend outwardly from the endwall of the float casing.
[0195] Clause 68 - The cartridge of clause 67, wherein the geometries include a first geometry and a second geometry, the endwall comprises an arcuate portion and a flat portion, wherein the first geometry extends outwardly from the flat portion, and the second geometry extends outwardly from the arcuate portion.
[0196] Clause 69 - The cartridge of any one of clauses 65-68, wherein the protrusions comprise an elongate ridge extending outwardly from the lateral sidewalls; and, optionally, wherein the elongate ridges are arcuate.
[0197] Clause 70 - The cartridge of any one of clauses 66-69, wherein one of the lateral sidewalls defines a recess with the cartridge further comprising a magnetic element disposed within the recess.
[0198] Clause 71 - A method of estimating blood loss with a system including a console including a sensor assembly, an actuator, a peristaltic pump, and a controller, wherein a cartridge is inserted into the console and includes a fluid reservoir, a detection window, a conduit assembly, an inlet fitting, a first outlet fitting, and a fluid level sensor, the method comprising: operating the peristaltic pump with the cartridge in a recirculation mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection window, through the conduit assembly, and into the fluid reservoir; detecting, with the fluid level sensor, a fluid level of the liquid medical waste within the fluid reservoir; actuating, with the controller, the actuator of the console to move the cartridge from the recirculation mode to a purge mode in which the liquid medical waste is directed through the conduit assembly and through the first outlet fitting; and estimating blood loss based on an analysis of the liquid medical waste in the purge mode.
[0199] Clause 72 - A method of performing a cleaning cycle with a cartridge used with a console for quantifying blood within liquid medical waste, wherein the console includes a sensor assembly, first and second actuators, a peristaltic pump, a controller, and a display, wherein the cartridge is inserted into the console and includes a fluid reservoir, a detection block, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: operating the peristaltic pump with the cartridge in a recirculation mode in which the cleaning fluid is drawn from the fluid reservoir, through the detection block, through the conduit assembly, and into the fluid reservoir; actuating, with the controller, the first and second actuators of the console to move the cartridge from the recirculation mode to a purge mode in which the cleaning fluid is directed through the conduit assembly and through the first outlet fitting; detecting, with the sensor assembly, an optical characteristic of the detection block; and providing a notification on the display as to whether the cartridge is sufficiently clean for reuse based on the optical characteristic.
[0200] Clause 73 - The method of clause 72, further comprising determining, with the controller, that the cartridge is not sufficiently clean for reuse if the optical exceeds a predetermined threshold.
[0201] Clause 74 - The method of clause 72 or 73, wherein the console further includes an identification reader, the method further comprising: reading, with the identification reader, an identification tag coupled to the cartridge; receiving, at the controller, data from the identification tag, wherein the data includes a number of uses of the cartridge; comparing the number of uses against a predetermined number; and providing the notification on the display that the cartridge is not sufficiently clean for reuse if the number of uses exceeds the predetermined number.
[0202] Clause 75 - The method of clause 74, further comprising: providing, on the display, a prompt to inquire the cleaning cycle is desired if the number of uses does not exceed the predetermined number; and receiving, on the display, a response to the prompt.
[0203] Clause 76 - The method of clause 75, further comprising: iterating, with the controller, the number of uses associated with the cartridge during or after completion of the cleaning cycle; and optionally, writing the iterated number of uses to the identification tag.
[0204] Clause 77 - The method of any one of clauses 72-76, wherein the detection block is removably coupled to a housing of the cartridge, the method further comprising replacing the detection block with a replacement detection block after each use of the cartridge.
[0205] Clause 78 - A method of performing a cleaning cycle with a cartridge used with a console for quantifying blood within liquid medical waste, wherein the console includes a sensor assembly, a controller, and a display, wherein the cartridge is inserted into the console and includes a fluid reservoir, a detection block, a conduit assembly, an inlet fitting, and a first outlet fitting, the method comprising: causing operation of a vacuum source to draw cleaning fluid through the first inlet fitting and into the fluid reservoir, through the detection block, through the conduit assembly, and out of the cartridge via the first outlet fitting; detecting, with the sensor assembly, an optical characteristic of the detection block; and providing a notification on the display as to whether the cartridge is sufficiently clean for reuse based on the optical characteristic. [0206] Clause 79 - A console for estimating blood loss, the console comprising: a cartridge receiver defining an opening configured to removably receive any of the implementations of the cartridge disclosed herein; non-transitory computer readable medium storing instructions configured to be implemented on one or more controllers to perform the methods disclosed herein; and a display in electronic communication with the one or more controllers and configured to display the estimated blood loss.
[0207] Clause 80 - The console of clause 79, further comprising a fluid level sensor disposed within or adjacent to the cartridge receiver, wherein the fluid level sensors arc disposed within the console such that the fluid level sensors are positioned adjacent to the cartridge when the cartridge is seated within the cartridge receiver.
[0208] Clause 81 - The console of clause 79, wherein the sensor assembly further comprises: an upper sensor bracket comprising an upper mount mounted within the cartridge receiver, an upper sensor head movably coupled to the upper mount, and an upper biasing member configured to bias the upper sensor head away from the upper mount and into direct contact with an upper surface of the detection block; a lower sensor bracket comprising a lower mount mounted within the cartridge receiver, a lower sensor head movably coupled to the lower mount, and a lower biasing member configured to bias the lower sensor head away from the lower mount and into direct contact with a lower surface of the detection block; optical emitter disposed on one of the upper sensor head and the lower sensor head; and optical detector disposed on the other one of the upper sensor head and the lower sensor head.
[0209] Clause 82 - The console of clause 81, wherein the sensor assembly further comprises: a lateral sensor bracket comprising a lateral mount mounted within the cartridge receiver, a lateral sensor head movably coupled to the lateral mount, and a lateral biasing member configured to bias the lower sensor head away from the lower mount and into direct contact with a lower surface of the detection block; and an additional optical detector disposed on the lateral sensor head.
[0210] Clause 83 - The console of clause 82, wherein the upper sensor bracket, the lower sensor bracket, and the lateral sensor bracket each comprise at least one of a collinear joint and a revolute joint.
[0211] Clause 84 - A console for quantifying blood within liquid medical waste, the console comprising: a housing; optical emitters; optical detectors configured to measure transmission of scatter of light being emitted by the optical emitters; a signal conditioning circuit in electronic communication with the optical detectors and configured to receive signals from the optical detectors that are indicative of the transmission and the scatter of the light through the liquid medical waste, wherein the signal conditioning circuit comprises a log amplifier, and a second amplifier arranged in series with the log amplifier to condition the signals; and a controller in electronic communication with the signal conditioning circuit, wherein the controller is configured to determine blood concentration within the liquid medical waste based on the conditioned signals.
[0212] Clause 85 - The console of clause 84, wherein the second amplifier is a noninverting amplifier.

Claims

1. A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly and a peristaltic pump, the cartridge comprising: a housing defining a fluid reservoir; a detection block defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste passing through the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting in fluid communication with the fluid reservoir and configured to be removably coupled with an inlet suction tube; a first outlet fitting configured to be removably coupled with a first outlet suction tube operably coupled to an external vacuum source; first and second conduits disposed within or formed with the housing; and a third conduit coupled to the housing and configured to engage the peristaltic pump of the console to move the liquid medical waste from the fluid reservoir, through the detection block, and to either (i) the first conduit to be recirculated or (ii) to the second conduit to be purged.
2. A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly, first and second actuators, and a peristaltic pump, the cartridge comprising: a housing defining a fluid reservoir; a detection block defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting in fluid communication with the fluid reservoir and configured to be removably coupled with an inlet suction tube; a first outlet fitting configured to be removably coupled with a first outlet suction tube; and a conduit assembly comprising a first conduit, a second conduit, and a third conduit, wherein the conduit assembly is configured to interface with the first and second actuators and the peristaltic pump of the console to selectively move the cartridge between (i) a recirculation mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the second conduit, and into the fluid reservoir, and (ii) a purge mode in which the liquid medical waste is drawn from the fluid reservoir, through the detection block, through the third conduit, through the first conduit, and through the first outlet fitting.
3. The cartridge of claim 1 or 2, further comprising a second outlet fitting in fluid communication with the fluid reservoir and configured to be removably coupled with a second suction tube to provide overfill relief to the fluid reservoir in which fluid is drawn from the fluid reservoir through the second outlet fitting without passing through the detection block.
4. The cartridge of any one of claims 1-3, wherein the housing comprises an interior bander separating the fluid reservoir from an inner compailment, and wherein the first conduit and the second conduit are tubes disposed within the inner compailment.
5. The cartridge of claim 4, wherein a side the housing further defines a first lateral aperture exposing a portion of the first conduit.
6. The cartridge of claim 5, wherein the side of the housing further defines a second lateral aperture exposing a portion of the second conduit.
7. The cartridge of claim 5 or 6, wherein the housing further comprises: a first projection extending from the interior barrier and aligned with the first lateral aperture; and a second projection extending from the interior barrier and aligned with the second lateral aperture, wherein the first and second projections are configured to facilitate flow control-based pinching of a respective one of the exposed portions of the first and second conduits.
8. The cartridge of any one of claims 1-7, wherein the detection block comprises upper and lower surfaces respectively defining upper and lower openings that are aligned with one another to form the detection window.
9. The cartridge of claim 8, wherein the detection block further comprises a lateral surface extending between the upper and lower surfaces, wherein the lateral surface defines a lateral opening that further forms the detection window.
10. A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly, first and second actuators, and a peristaltic pump, the cartridge comprising: a housing defining a fluid reservoir; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear’ for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; a first outlet fitting configured to be removably coupled with a first outlet suction tube operably coupled to an external vacuum source; a conduit assembly comprising: a conduit junction; a first conduit providing fluid communication between the first outlet fitting and the conduit junction; a second conduit providing fluid communication between the conduit junction and the fluid reservoir; and a third conduit providing fluid communication between the conduit junction and the detection block, wherein the third conduit is configured to be arranged in operable engagement with the peristaltic pump of the console.
11 . The cartridge of claim 10, wherein the first conduit comprises an outlet coupled to the first outlet fitting and an inlet coupled to a conduit junction, wherein the second conduit comprises an inlet coupled to the conduit junction and an outlet coupled to the housing, and wherein the third conduit comprises an outlet coupled to the conduit junction, and an inlet coupled to the housing.
12. The cartridge of claim 10 or 11, further comprising a second outlet fitting coupled to the housing and in fluid communication with the fluid reservoir, wherein the second outlet fitting is configured to be removably coupled with a second suction tube operably coupled to the external vacuum source.
13. The cartridge of claim 12, wherein the second outlet fitting is positioned near an upper aspect of the housing for the external vacuum source to provide overfill relief to the fluid reservoir.
14. The cartridge of claim 13, wherein the inlet fitting is positioned near the upper aspect of the housing such that the liquid medical waste descends into the fluid reservoir under influence of gravity.
15. The cartridge of claim 14, wherein the second conduit is coupled to the housing near’ the upper aspect such that recirculated liquid medical waste descends into the fluid reservoir under the influence of gravity.
16. The cartridge of any one of claims 1-15, wherein the detection block is position at a base of the housing.
17. The cartridge of claim 16, wherein the detection block extends perpendicularly from an inner side of the housing.
18. The cartridge of any one of claims 1-17, further comprising at least one fluid level sensor coupled to the housing and disposed within the fluid reservoir.
19. The cartridge of claim 18, further comprising an electronic connector coupled to the housing or the console and in electronic communication with the at least one level sensor.
20. The cartridge of any one of claims 1-19, further comprising a radiofrequency identification tag coupled to the housing.
21. The cartridge of any one of claims 1-20, wherein the detection block is removably coupled to the housing.
22. A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly, first and second actuators, and a peristaltic pump, the cartridge comprising: a housing defining a fluid reservoir and a compartment separated by an interior barrier; a detection block coupled to the housing and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting in fluid communication with the fluid reservoir and configured to be removably coupled with an inlet suction tube; a first outlet fitting configured to be removably coupled with a first outlet suction tube; and a conduit assembly disposed within the compartment and comprising a first conduit and a second conduit, wherein the housing further defines a first lateral aperture exposing a portion of the first conduit and configured to be aligned with the first actuator of the console, and a second lateral aperture exposing a portion of the second conduit, wherein the lateral second aperture is configured to be aligned with the second actuator of the console.
23. The cartridge of claim 22, wherein the first lateral aperture is positioned distal or closer to a front of the housing than the second aperture.
24. The cartridge of claim 22 or 23, wherein the first lateral aperture is positioned closer to the detection block than the second aperture.
25. The cartridge of any one of claims 22-24, wherein the housing further comprises: a first projection disposed within the compartment and aligned with the first lateral aperture; and a second projection disposed within the compartment and aligned with the second lateral aperture, wherein the first and second projections are configured to facilitate flow control-based pinching of a respective one of the exposed portions of the first and second conduits with actuation of a respective one of the first and second actuators of the console.
26. The cartridge of any one of claims 22-25, wherein the first and second projections comprise an arcuate face.
27. The cartridge of any one of claims 22-26, wherein the first and second lateral apertures are cruciform in shape.
28. The cartridge of any one of claims 25-27, wherein the first and second projections extend from the interior barrier towards a respective one of the first and second lateral apertures.
29. The cartridge of claim 28, further comprising tube management geometries extending from the interior barrier.
30. The cartridge of claim 28 or 29, wherein the detection block extends from the interior barrier.
31. The cartridge of any one of claims 22-30, wherein the conduit assembly further comprises a third conduit positioned external to the compailment and configured to be arranged in operable engagement with the peristaltic pump of the console.
32. A cartridge for estimating blood loss within liquid medical waste with a console including a sensor assembly, first and second actuators, and a peristaltic pump, the cartridge comprising: a housing comprising a base, an upper surface opposite the base, a front and opposing lateral sides extending between the base and the upper surface, and an interior barrier, wherein the housing defines a fluid reservoir between one of the opposing lateral sides the interior barrier and a compartment between the other one of the opposing lateral sides and the interior barrier; a detection block extending from the compartment and defining a fluid channel in fluid communication with the fluid reservoir, wherein the detection block further defines a detection window that is optically clear for the liquid medical waste within the fluid channel to be optically detectable with the sensor assembly of the console; an inlet fitting coupled to the front of the housing and in fluid communication with the fluid reservoir, wherein the inlet fitting is configured to be removably coupled with an inlet suction tube; a first outlet fitting coupled to the front of the housing and configured to be removably coupled with a first outlet suction tube; and a conduit assembly disposed within the compartment.
33. The cartridge of claim 32, further comprising a conduit junction disposed within the compartment, wherein first, second, and third conduits of the conduit assembly are coupled to the conduit junction.
34. The cartridge of claim 32 or 33, wherein the detection block is positioned at the base of the housing.
35. The cartridge of any one of claims 32-34, wherein the detection block extends perpendicularly from the interior barrier.
36. The cartridge of any one of claims 32-35, wherein the detection block comprises upper and lower surfaces respectively defining upper and lower openings that arc aligned to form the detection window.
37. The cartridge of claim 36, wherein the detection block further comprises a lateral surface extending between the upper and lower surfaces, wherein the lateral surface defines a lateral opening that further forms the detection window.
38. The cartridge of any one of claims 32-37, further comprising at least one fluid level sensor coupled to the housing and disposed within the fluid reservoir.
39. The cartridge of any one of claims 32-38, further comprising a mounting flange extending from the interior barrier and defining a slot, wherein the detection block is configured to be removably coupled to the mounting flange such that a portion of the detection block is disposed within the slot.
40. The cartridge of claim 39, further comprising: a first identification tag disposed on the housing; and a second identification tag disposed on the detection block.
41. The cartridge of claim 40, further comprising seals disposed at interfaces between the fluid channel and corresponding ports of the mounting flange.
42. A console for estimating blood loss, the console comprising: a cartridge receiver defining an opening configured to removably receive any of the implementations of the cartridge disclosed herein; non-transitory computer readable medium storing instructions configured to be implemented on one or more controllers to perform methods disclosed herein; and a display in electronic communication with the one or more controllers and configured to display the estimated blood loss.
43. A system for estimating blood loss, the system comprising: the console of claim 42; and a medical waste collection system comprising a vacuum source configured to be arranged in fluid communication with the inlet fitting, and a waste canister configured to be arranged in fluid communication with the first outlet fitting.
PCT/US2024/061442 2023-12-21 2024-12-20 Cartridge, console, and methods for estimating blood loss in medical waste Pending WO2025137561A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202480030196.0A CN121079116A (en) 2023-12-21 2024-12-20 Boxes, consoles, and methods for estimating blood loss in medical waste.
AU2024408980A AU2024408980A1 (en) 2023-12-21 2024-12-20 Cartridge, console, and methods for estimating blood loss in medical waste

Applications Claiming Priority (4)

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US202363613122P 2023-12-21 2023-12-21
US63/613,122 2023-12-21
US202463719379P 2024-11-12 2024-11-12
US63/719,379 2024-11-12

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7621898B2 (en) 2005-12-14 2009-11-24 Stryker Corporation Medical/surgical waste collection unit including waste containers of different storage volumes with inter-container transfer valve and independently controlled vacuum levels
US20110051136A1 (en) * 2008-04-04 2011-03-03 Sven Milton Measurement of particles in liquid using reflected light
US10105470B2 (en) 2012-10-24 2018-10-23 Stryker Corporation Mobile instrument assembly for use as part of a medical/surgical waste collection system, the assembly including a vacuum source to which a mobile waste collection cart can be releasably attached
US10471188B1 (en) 2019-04-12 2019-11-12 Stryker Corporation Manifold for filtering medical waste being drawn under vacuum into a medical waste collection system
US11160909B2 (en) 2015-12-24 2021-11-02 Stryker Corporation Waste collection unit
US20220008637A1 (en) 2018-09-27 2022-01-13 Gauss Surgical, Inc. Systems and methods for inline fluid characterization
WO2022103912A1 (en) 2020-11-11 2022-05-19 Stryker Corporation Quantifying blood loss with a medical waste collection system
WO2023076235A1 (en) * 2021-10-26 2023-05-04 Stryker Corporation Quantifying blood loss by recirculating waste fluid with a medical waste collection system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7621898B2 (en) 2005-12-14 2009-11-24 Stryker Corporation Medical/surgical waste collection unit including waste containers of different storage volumes with inter-container transfer valve and independently controlled vacuum levels
US20110051136A1 (en) * 2008-04-04 2011-03-03 Sven Milton Measurement of particles in liquid using reflected light
US10105470B2 (en) 2012-10-24 2018-10-23 Stryker Corporation Mobile instrument assembly for use as part of a medical/surgical waste collection system, the assembly including a vacuum source to which a mobile waste collection cart can be releasably attached
US11160909B2 (en) 2015-12-24 2021-11-02 Stryker Corporation Waste collection unit
US20220008637A1 (en) 2018-09-27 2022-01-13 Gauss Surgical, Inc. Systems and methods for inline fluid characterization
US10471188B1 (en) 2019-04-12 2019-11-12 Stryker Corporation Manifold for filtering medical waste being drawn under vacuum into a medical waste collection system
WO2022103912A1 (en) 2020-11-11 2022-05-19 Stryker Corporation Quantifying blood loss with a medical waste collection system
WO2023076235A1 (en) * 2021-10-26 2023-05-04 Stryker Corporation Quantifying blood loss by recirculating waste fluid with a medical waste collection system

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