Inaccurate estimation of fluid loss (e.g., blood loss) from a patient, such as during a surgical procedure, may put the patient's health at risk. For example overestimation of patient blood loss results in the unnecessary consumption of transfusion-grade blood, and may lead to shortages of transfusion-grade blood that is needed for other patients. As another example, underestimation of patient blood loss may lead to delayed resuscitation and transfusion, increased risk of infections, tissue death, or even patient death, such as in the event of hemorrhage.
Furthermore, inaccurate estimation may be a significant contributor to high operating and surgical costs for hospitals, clinics, and other medical facilities. In particular, unnecessary blood transfusions, resulting from overestimation of patient blood loss, lead to higher operating costs for medical institutions. Additionally, delayed blood transfusions, resulting from underestimation of patient blood loss, have been associated with billions of dollars in avoidable patient infections and re-hospitalizations annually. Thus, it is desirable to have more accurate systems and methods for assessing fluids from a patient.
Described herein are systems and methods for assessing fluids from a patient. Generally, a system for assessing fluids from a patient may be operated in a fill mode and a flush mode. The system may include a receptacle including an inlet port, an outlet port, and a third port; a valve system in fluidic communication with the receptacle; and one or more features in the receptacle to aid in optical imaging of fluids. In the fill mode, the valve system may direct suction from a vacuum source through the third port into the receptacle, thereby drawing fluid through the inlet port into the receptacle. Additionally, in the flush mode, the valve system may direct suction from the vacuum source through the outlet port, thereby drawing fluid through the outlet port out of the receptacle. The receptacle may further include a fourth port, such that in the fill mode the valve system directs suction from the vacuum source to a fluid retrieval device coupled to the inlet port and closes the fourth port. Conversely, in the flush mode, the valve system may open the fourth port.
The valve system may be configured to be automatically actuated or manually actuated. For example, in some variations, the system may include a controller configured to actuate the valve system to toggle between the fill mode and flush mode. The controller may be configured to actuate the valve system based on a fluid level signal indicating a volume of fluids detected in the receptacle. The system may include one or more sensors coupled to the receptacle and configured to detect the volume of fluids in the receptacle, and to generate a fluid level signal based on the detection of volume of fluids in the receptacle. More specifically, the system may include a first sensor configured to detect a high threshold volume of fluids in the receptacle, and/or a second sensor configured to detect a low threshold volume of fluids in the receptacle.
In some variations, the one or more features in the receptacle to aid optical imaging of fluids may include an insert that cooperates with a surface of the receptacle to define a region of substantially uniform thickness. The insert may be coupled to the receptacle or may be integrally formed with the receptacle. In other variations, the one or more features in the receptacle may include a surface of the receptacle that at least partially defines a region in which fluid has a color gradient. Furthermore, the system may include an optical fiducial on the receptacle.
Generally, a method for assessing fluids from a patient may use a receptacle including an inlet port, an outlet port, and a third port. The method may include collecting fluids from the patient in the receptacle by suctioning from a vacuum source through the third port of the receptacle to draw fluids through the inlet port into the receptacle, obtaining an image of the collected fluids with the aid of one or more features in the receptacle, and draining the collected fluids upon reaching a high threshold volume of fluids in the receptacle by suctioning from the vacuum source through the outlet port, thereby drawing fluids through the outlet port and out of the receptacle. The method may further include collecting fluids from the patient in the receptacle upon reaching a low threshold volume of fluids in the receptacle. In some variations, the receptacle may further include a fourth port, and the method may include closing the fourth port when collecting fluids and opening the fourth port when draining the collected fluids.
The method may include actuating a valve system to toggle between collecting fluids and draining fluids. In some variations, the method may include detecting the volume of fluids in the receptacle and generating a fluid level signal using one or more sensors based on the detection of volume of fluids in the receptacle. The valve system may be actuated based on the level signal indicating a volume of fluids detected in the receptacle.
The method may further include identifying a receptacle image region in the obtained image and determining one or more pixel color values of at least a portion of the receptacle image region. An estimated concentration of a blood component in the receptacle may be based on the one or more pixel color values. Furthermore, an estimated quantity of the blood component in the receptacle may be based on the estimated concentration of the blood component in the receptacle and an estimated volume of fluids in the receptacle.
Examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings. The following description is not intended to limit the invention to these embodiments, but rather to enable a person skilled in the art to make and use this invention.
I. Systems and Methods Overview
Generally, the systems and methods described herein for assessing fluids from a patient are used to assess fluids that are lost by a patient during a surgical procedure. Images of the fluids may be intermittently generated and evaluated in order to assess the fluids. For example, the systems and methods described herein may be used to track or otherwise estimate, based at least in part on the images of fluid, a quantity of fluid (e.g., blood) lost by the patient during the surgical procedure and/or quantity of a blood component (e.g., hemoglobin). In other examples, the systems and methods may additionally or alternatively be used to track or otherwise assess total mass, total volume, and/or aggregate concentration of red blood cells, platelets, plasma, and/or other blood components lost by the patient during the surgical procedure. These assessments, and other fluid-related information described in further detail below, may be updated and displayed in substantially real-time during the surgical procedure and/or at the conclusion of the surgical procedure.
More specifically, during a surgical procedure, fluids lost by the patient may be collected and passed into a receptacle. In one variation, the system has a valve system that alternates between a fill mode in which the fluids accumulate in the receptacle and a flush mode in which accumulated fluids drain out of the receptacle (e.g., to a sealed waste management system). For example, as shown in
The systems and methods described herein may be used in a variety of settings, including in a hospital or clinic setting (e.g., operating or clinic setting), a military setting (e.g., battlefield) or other suitable medical treatment settings. This information can be used to improve medical treatment of patients, as well as reduce costs to medical institutions and patients. For instance, medical practitioners (e.g., nurses, surgeons) who receive this information during and/or after a surgical procedure can then make appropriate decisions for treatment of the patient (such as determining whether to provide a blood transfusion to the patient and how much blood is necessary) based on more accurate information on patient status. In particular, with more accurate information on the patient fluid loss, practitioners can, for example, avoid providing unnecessary blood transfusions (which deplete inventory of blood transfusions and increase operating costs and medical bills), while also avoiding delayed blood transfusions (which would risk patient health).
II. Systems for Assessing Fluids from a Patient
Generally, a system for assessing fluids from a patient may have one or more components enabling a fill mode and a flush mode. In the fill mode, patient fluids are accumulated in the receptacle, while in the flush mode, the patient fluids are drained out of the receptacle. For instance, the system may have components that operate in the fill mode to accumulate patient fluids in the receptacle until the receptacle contains a predetermined threshold volume of fluid, upon which the components may operate in the flush mode to drain patient fluids from the receptacle. When another predetermined threshold volume of fluid remains in the reservoir (or when a predetermined threshold volume of fluid has been drained), the components again may operate in the fill mode to accumulate more patient fluids in the reservoir in another fill-flush cycle. In this manner, the components may toggle between the fill and flush modes to intermittently fill and empty the reservoir while the lost patient fluids continue to be collected and passed into the reservoir. Additionally, at one or more points in time while the patient fluids are in the receptacle (e.g., when a threshold volume of fluid has accumulated in the receptacle, before the system drains the patient fluids), a camera may generate one or more images of the fluid, which can be evaluated to assess fluid-related information.
As shown in
The system may include one or more filters to remove clots, solids, and/or other non-fluidic debris out of the patient fluids. For instance, at least one filter may be placed in the fluidic path before the receptacle 110 (e.g., in the fluid retrieval device or in tubing between the fluid retrieval device and the receptacle), in the receptacle (e.g., coupled to the inlet port or outlet port), before one or more components of the valve system 140 (e.g., in tubing between the receptacle and the valve system), and/or before or in the second receptacle 102. However, one or more filters may be placed in any suitable location in the fluidic path between the fluid retrieval device and the second receptacle.
At least some of the electronic components of the system may be in an integrated device and placed near the patient during the surgical procedure (e.g., in the operating room) to assess patient fluids that are collected and passed through the receptacle. For instance, at least the camera, processor, and/or display may be combined in a handheld or mobile electronic computing device 170 (e.g., that executes a native fluid analysis application program). Such a handheld or mobile device may, for example, be a tablet computer, laptop computer, mobile smartphone, etc. which may include a camera 172, processor 176, and a display 174. However, in other variations some or all of these components may be separated as discrete interconnected devices. For example, the camera and display may be located substantially near the receptacle during the surgical procedure (e.g., in the operating room) while the processor may be located at a remote location (e.g., in the operating room separate from the camera and/or display, or outside the operating room), communicating with the camera and display through a wired or wireless connection or other network.
Receptacle
The receptacle is configured to receive and accumulate patient fluids (e.g., from a fluid retrieval device, as well as to allow the accumulated patient fluids to drain. Generally, as shown in
Generally, at least the body of the receptacle may be substantially transparent or translucent to white light. For example, the receptacle may be made of blow-molded polyethylene terephthalate (PET) or injection-molded Poly(methyl methacrylate) (PMMA), though other plastics, glass, or other materials permitting visible light transmission may be used. In some variations, the receptacle material may be rigid or semi-rigid so as to withstand suction forces without collapsing. An anti-glare coating, anti-glare finish, or an anti-glare strip (e.g., sticker or decal) may be arranged on a surface of the receptacle.
The internal volume 222 may be generally frustoconical. Alternatively, the internal volume may be generally prismatic (e.g., generally rectangular prismatic as in
The receptacle 110 may include one or more slopes that direct fluid volumes to pool in a particular region of the internal volume 122, which may help to more completely drain the receptacle during the flush mode and/or accumulate smaller volumes of fluids together for more accurate analysis of the receptacle contents. The fluids may pool where a lower end of the slope encounters a receptacle wall or where the lower ends of multiple slopes intersect. For instance, a first slope in the receptacle may generally encourage fluid to pool near one side of the bottom of the slope (e.g., toward sump 126 and sump pickup 128, against the receptacle wall as shown in
The receptacle may further include one or more internal baffles or other features to help prevent incoming fluids (e.g., entering through inlet port 112) from moving directly into the third port 116 during the fill mode.
The top 224 may provide a substantially fluid-tight seal for the internal volume. The top 224 may be integral with the body 220 of the receptacle, or alternatively may be coupled to the body 220 of the receptacle 210. For instance, the lid may be threaded for mating with the body 220, or include locking tabs or other locking features that allow the lid to be snapped or otherwise sealed onto the body 220. The top 224 may include additional sealing features such as a gasket. Furthermore, the top 224 may include caps or other covers to seal one or more of the ports before and/or after the receptacle is used during the surgical procedure (e.g., during storage or disposal of the receptacle 210).
The system may further include a holder configured to receive the receptacle. In these variations, the receptacle may be a liner that is placed inside the holder, and, in some instances, the receptacle may be designed to be single-use or disposable while the holder may be designed to be reusable. The holder may be substantially rigid or semi rigid, while the receptacle may be more flexible than the holder. In some variations, the holder may include a canister, cup, or other outer container with an internal recess that receives and holds the receptacle. In other variations, the holder may additionally or alternatively include a framework (e.g., lattice, one or more rings, etc.) creating an internal space that receives and holds the receptacle Like the receptacle, the holder may include a material that is substantially transparent or translucent to white light.
Ports
As shown in
The inlet port functions to pass fluids into the receptacle. In particular, as shown in
The outlet port functions to drain fluids from the receptacle when the system is operating in the flush mode. In particular, the outlet port may be fluidically coupled via tubing to a second receptacle, such as for disposal of the fluids, and allow transfer of fluids from the first receptacle to the second receptacle. In one variation, as shown in
In another variation, as shown in
The outlet port may include a valve that opens and closes to regulate flow through the outlet port, and/or substantially prevent fluids from traveling in a reverse direction back into the receptacle through the outlet port (e.g., a one-way valve). Furthermore, it should be appreciated that the receptacle may include multiple outlet ports. For instance, the outlet port arrangements shown in
The third port functions to pass suction from a vacuum source into the receptacle when the system is operating in the fill mode, where suction can thereby be communicated within the receptacle to draw fluids through the inlet port into the receptacle. For instance, as shown in
The receptacle may further include a fourth port, which functions as a vent to facilitate draining of the fluid through the outlet port when the system is operating in the flush mode. The fourth port may be located on the receptacle such that it is substantially opposite to the accumulated volume of fluid in the receptacle, in order to provide a pressure differential facilitating the draining of the fluid. For instance, as shown in
Optical Fiducial
As shown in
The optical fiducial may include a color fiducial. The color fiducial may be coupled to or integral with the receptacle or its packaging, and be associated with color-related information to enable color normalization of the images of the fluid in the receptacle, such as to compensate for variations in lighting conditions. In one variation, the color fiducial may display one or more red hues, each of which has an assigned or known color value. For example, different hues may be displayed and arranged in different boxes or segments in a grid, strip, ring, color wheel, or any suitable shape for displaying color-normalizing information. Furthermore, the color fiducial may be in the form of a decal, sticker, ring or other component configured to couple to the receptacle or receptacle packaging, or any component suitable for associating the color fiducial with the receptacle or its packaging. The images of fluid in the receptacle can be color-adjusted (e.g., adjustment of exposure, contrast, saturation, temperature, tint, etc.) until an imaged color fiducial has a color value matching the assigned or known color value of the color fiducial.
Valve System
The valve system functions to toggle the system between the fill mode and the flush mode. The valve system includes at least one valve that redirects suction from a vacuum source such that the suction may be used to alternately draw fluid into the receptacle during the fill mode, and to draw fluid out of the receptacle during the flush mode.
Fill and Flush Modes
Generally in the fill mode, the valve system directs suction from a vacuum source through the third port of the receptacle into the internal volume of the receptacle, thereby drawing fluid through the inlet port of the receptacle into the internal volume of the receptacle. Furthermore, generally in the flush mode, the valve system directs suction from the vacuum source through the outlet port of the receptacle, thereby drawing fluid through the outlet port out of the internal volume of the receptacle.
For example, as shown in
In this example, when the valve system is operating in the fill mode (shown in
In another example, as shown in
In this example, when the valve system is operating in the fill mode, the valve 244 is open and the valve 246 is closed, thereby directing suction from the vacuum source 204 through valve 244 and port 216 of the receptacle. The valve coupled to the inlet 212, if present, is open to enable the fluid retrieval device, while the valve coupled to the outlet 214, if present, is closed. Additionally, the valve coupled to the fourth port 218 is closed, such that the suction is communicated through the internal volume 222 to inlet port 212, which draws fluid from fluid retrieval device (or other fluid source) into the internal volume 222 of the receptacle. Conversely, when the valve system is operating in the flush mode, the valve 244 is closed and the valve 246 is open, thereby directing suction from the vacuum source 204 through valve 246 and the outlet port 214 of the receptacle. The valve coupled to the inlet 212, if present, is closed to disable the fluid retrieval device, while the valve coupled to the outlet 214, if present, is open. Additionally, the valve coupled to the fourth port 218 is open, such that the internal volume 222 is vented open to ambient pressure and there is a pressure differential facilitating the draining of the fluid through outlet port 214. Furthermore, in some variations, both valves 244 and 246 may be closed to suspend the communication of suction into the receptacle (e.g., during image capture of fluid in the receptacle).
In other variations, the valve system may include other suitable combinations of valves that enable rerouting of suction from the vacuum source to fill and empty the receptacle.
Actuation
In one variation, at least part of the valve system may be automatically controlled (e.g., by a controller as further described below). For example, the valve system may include an electromagnetic actuator (e.g., solenoid) that selectively opens and closes one or more valves between valve configurations for the fill and flush modes. As another example, the valve system may include a passive, automatic mechanical or magnetic actuator. Such automatically controlled valve systems may be based on sensor signals that trigger the fill and/or flush modes, as further described below. However, any suitable actuating device may be used to automatically actuate one or more of the valves in the valve system.
In another variation, at least part of the valve system may additionally or alternatively be manually controlled by a user. For instance, the valve system may include a manual actuator (e.g., lever, handle, wheel, button, plunger, switch, etc.) in order to adjust one or more valves between valve configurations for the fill and flush modes. The particular kind of manual actuation may vary, for example, on the type of valve (e.g., ball valve, butterfly valve, gate valve, diaphragm valve, etc.), though the valve system may include any suitable interface for actuating one or valves in the valve system based on user input. In these variations, the system may provide audible and/or visual instructions or warnings that prompt a user to actuate the valve system between the fill and flush modes.
Camera
As shown in
The camera may include at least one optical image sensor (e.g., CCD, CMOS, etc.) that captures a color optical digital image with red, green, and blue (RGB) color components for the pixels, and/or other suitable optical components. For example, the camera may include a single image sensor paired with suitable corresponding optics and/or filters (e.g., color filter arrays such as a Bayer pattern filter). As another example, the camera may include multiple image sensors paired with suitable corresponding optics, such as at least one prism or diffractive surface to divide white light into separate color channels (e.g., RGB), each of which is detected by a respective image sensor. However, the camera 174 may include any suitable image sensors and other optics components to enable the camera to generate images of the fluid in the receptacle.
The camera may be configured to transmit the images to a processor for analysis, and/or to a database that stores the images, through a wired or wireless connection. As shown in
Sensors
The system may further include one or more sensors configured to detect the volume of fluids in the receptacle and to generate a fluid level signal based on the detection of fluid volume or fluid level in the receptacle. The fluid level signal may be used to trigger the actuation or toggling between the fill and flush modes of the valve system, and/or to estimate fluid volume in the receptacle (e.g., for estimation of current or cumulative quantity of blood volume and/or quantity of blood component lost by the patient). The sensors may include fluid level sensors coupled to the receptacle or near the receptacle. Additionally or alternatively, the camera generating images of the fluids in the receptacle may be treated as a sensor, in that the images may be analyzed to detect fluid level.
Fluid Level Sensors
The system may include one or more point-level sensors that indicate whether the fluid level in the receptacle is above or below a particular threshold sensing point. For example, one or more fluid level sensors may include a binary fluid level sensor that outputs a fluid level signal (e.g., voltage) of one value when the sensor detects a fluid volume not satisfying a threshold, and outputs a fluid level signal of another value when the sensor detects a fluid volume satisfying the threshold.
In one variation with point-level sensors, the system may include one or more sensors configured to detect at a high threshold volume of fluids in the receptacle and generate a fluid level signal indicating the high threshold fluid volume. For instance, as shown in
In another variation with point-level sensors, the system may additionally or alternatively include one or more sensors configured to detect a low threshold volume of fluids in the receptacle and generate a fluid level signal indicating the low threshold fluid volume. For instance, as shown in
Similarly, the system may include additional point-level sensors at discrete fluid level locations to provide additional information, such as regarding one or more intermediate fluid levels between a low threshold and a high threshold. Fluid level signals indicating intermediate fluid volumes may be used to trigger the camera to generate an image of the fluid in the receptacle as the receptacle fills with fluid. Additionally or alternatively, fluid level signals indicating intermediate fluid volumes may provide more frequent updates for estimates of the volume of fluid in the receptacle.
The system may include one or more continuous-level sensors that measure the fluid level in the receptacle and indicate a numerical value corresponding to fluid volume. For instance, a continuous-level sensor may output a fluid level signal (e.g., voltage) within a range corresponding to a measurable range of fluid volumes. As the receptacle is filled or drained, the particular value for the fluid level signal may be continually compared to a high threshold fluid volume and/or a low threshold fluid volume to determine whether the fluid volume in the receptacle satisfies either threshold. Furthermore, the particular value for the fluid level signal may be compared to other thresholds to trigger the camera to generate an image of the fluid in the receptacle, as the receptacle fills with fluid (e.g., every 5 mL added to the receptacle may trigger the camera).
Any suitable fluid level sensor may be used to detect fluid volume in the receptacle and generate a fluid level signal that indicates the detected fluid volume. For example, capacitance level sensors, conductive level sensors, ultrasonic level sensors, and/or optical sensors, etc. may be appropriate as point-level and/or continuous-level sensors. Furthermore, the system may additionally or alternatively include a magnetic float having a magnet sealed within. As fluid accumulates in the receptacle, the float may rise relative to one or more magnetic sensing points corresponding to threshold fluid volumes, which may, for example automatically trigger via a magnetic “signal” that automatically (e.g., mechanically) triggers toggling of fill and flush modes. Similarly, the system may additionally or alternatively include a mechanical sensor, such as a float mechanically coupled (e.g., with a lever) to the valve system such that as the float rises relative to one or more predetermined points corresponding to threshold fluid volumes, the float may automatically trigger via a mechanical “signal” that automatically triggers toggling of fill and flush modes.
Image Analysis for Fluid Level Detection
In another variation, fluid level may be detected by analyzing images of the fluid in the receptacle. For example, the camera can repeatedly capture images of the receptacle (e.g., every two seconds) and a processor may employ machine vision techniques, such as edge detection, to estimate fluid volume (e.g., determine whether the fluid volume depicted in each image satisfies a particular high or low threshold volume of fluids, and/or absolute quantity of fluid). In this variation, the fluid level signal may be generated by a processor embodied in, for example, a handheld or mobile device 170 that is separate from the receptacle.
Furthermore, the system may detect the volume of fluids in the receptacle based on any suitable combination of the above-described techniques. For example, the system can include a float having a color (e.g., green) generally contrasting to the color of patient fluids, which may enable identification of the float in an image using machine vision techniques. The identified position of the float in the images can be used, such as by comparing the float to optical fiducials, to estimate fluid volume and determine whether there is a high threshold fluid volume or low threshold volume fluid volume in the receptacle.
Controller
Particularly in variations in which the valve system is automatically actuated, the system may further include a controller configured to actuate the valve system to toggle between the fill mode and the flush mode. More specifically, the controller may be configured to actuate the valve system based on the fluid level signal generated by the one or more sensors in the sensor system.
For example, as shown in
The controller may additionally or alternatively be configured to control when the camera generates images of the fluid in the receptacle. In one variation, the controller 260 may trigger the camera to generate images whenever the receptacle is sufficiently full of fluid. For example, upon receiving a fluid level signal indicating a high threshold volume of fluid, the controller 260 may trigger the camera to generate images of the fluids in the receptacle. In another variation, the controller 260 may trigger the camera to periodically or intermittently generate images (e.g., every two seconds, every 5 mL of fluid added to the receptacle). In one or both of these variations, prior to triggering the camera, the controller 260 may additionally actuate part of the valve system 240 (e.g., close a valve coupled to inlet port 212 to disable the fluid retrieval device, open a valve coupled to the port 218 to open the internal volume 222 to ambient pressure, etc.) and/or wait a predetermined period of time (e.g., five seconds) to allow fluids in the receptacle to settle before generating the image of the fluids.
Imaging Aid
The system may include one or more features in or around the receptacle to aid in optical imaging of fluids. For example, one feature to aid in optical imaging may include an insert or light source arranged within the internal volume of the receptacle. As another example, the receptacle may define one or more slopes that further define the internal volume.
Insert
The system may include an insert arranged within the internal volume of receptacle, such as at or near a bottom of the internal volume. The insert may, for example, backscatter light through the fluid and improve the quality of images from which fluid-related information may be derived. In some variations, the insert and a surface of the receptacle may cooperate to define a first region with substantially uniform thickness such that fluid in the first region exhibits substantially uniform color. Pixel color values in image portions depicting the first region may, for example, be correlated to a blood component concentration (e.g., with template matching techniques, parametric modeling techniques described in further detail below). In particular, the insert may include a first feature that is substantially parallel to and offset from a surface of the receptacle, such that the first feature cooperates with the surface of the receptacle to form the first region of substantially uniform thickness. For example, the first feature may include an arcuate surface (e.g., the insert may be circular, semi-circular, or otherwise curved) in instances in which the receptacle surface is similarly arcuate (e.g., generally cylindrical). As another example, the first feature may include a generally planar wall (e.g., the insert may be at least a segment of a polygonal prism) in instances in which the receptacle surface is planar (e.g., rectangular tank). However, the insert may include any suitable features that generally track a surface of the receptacle so as to define a region of substantially uniform thickness between the insert and the surface of the receptacle.
The insert and a surface of the receptacle may additionally or alternatively cooperate to define a second region in which fluid exhibits a color gradient. Pixel color values in image portions depicting the second region may, for example, be correlated to a hemolysis level in the blood (e.g., with template matching techniques, parametric modeling techniques). To compensate for the effect of hemolysis on perceived pixel color value in images (e.g., due to different light scattering characteristics of whole red blood cells and free hemoglobin), algorithms and processes for evaluating images may be adjusted based on the known hemolysis concentration. In particular, the insert may include a second feature that generally tapers away from a surface of the receptacle, such that the second feature cooperates with the surface of the receptacle to form the second region in which fluid has a color gradient. For example, the second feature may have a surface with a linear profile, a non-linear profile, a stepwise function profile, etc. that generally angles away from the surface of the receptacle. However, the insert may include any suitable features that generally taper or angle away from a surface of the receptacle so as to define a region in which fluid has a color gradient between the insert and the surface of the receptacle.
For instance, as shown in
The insert 300a may be coupled to the receptacle. For example, the members 312a and 312b (and/or other portions of the insert) may be coupled to the receptacle wall 320 with fasteners (e.g., epoxy, magnets, etc.). As another example, the members 312a and 312b (and/or other portions of the insert) may be coupled to the receptacle wall 320 without fasteners, such as by press-fit or snap-fit. Additionally or alternatively, the members 312a and 312b (and/or other portions of the insert) may include features that interlock with complementary features on the receptacle surface 320 (e.g., splines and notches, dovetails, etc.). Such coupling may be substantially permanent or removable. For instance, in some variations, the insert may be removable from the receptacle for reuse. Alternatively, the insert 300a may be integrally formed with the receptacle (e.g., by injection molding or blow molding techniques).
In another variation as shown in
In another variation as shown in
The insert (or at least the surfaces 310) may include a material or coating that is white, substantially opaque, and generally impermeable to fluid. For instance, the insert may be made of injection-molded white plastic. The insert may alternatively include a color or pattern (e.g., grid, matrix barcode, QR code) that is observable (e.g., on surfaces 310) through the fluid. For instance, a color grid or matrix bar code coupled to the insert and observable through the receptacle surface 320 and fluid can be used to determine fluid parameters (e.g., fluid component concentrations) associated with fluid within the receptacle. For example, in one application, a color grid including a set of regions of color, each region associated with a blood component concentration value, can be applied to the insert. In this application, when a particular region of the color grid from the fluid is substantially visually indistinguishable from the fluid within the canister, the blood component concentration value associated with that region of the color grid can be taken as an estimated blood component concentration of the fluid. Similarly, a color pattern exhibiting a gradient in color (e.g., by including a pattern having successively blurrier edges between regions of the pattern) can be used to assess a level of hemolysis, in relation to a color gradient within fluid in the receptacle.
Light Source
The system may include a light source 318 configured to transmit light through a portion of fluid within the canister, which may, for example, help generate an optical image with a color gradient from which a hemolysis level of the fluid can be estimated. In the variation shown in
The light source (e.g., LED or laser) may emit wavelengths of light spanning or otherwise associated with one or more absorbance peaks in an absorbance spectrum for one or more target components of fluid in the receptacle. For instance, the light source 318 may be configured to provide a broad range, narrower range, or discrete waveband of light corresponding to absorbance peaks of one or more blood components. For example, in relation to hemoglobin, the light source 318 may be configured to provide wavelengths of light from about 400 nm to about 700 nm and between about 800 nm to about 950 nm. Additionally or alternatively, in relation to hemoglobin, the light source 318 can be configured to provide wavelengths of light associated with absorbance peaks/spectra of one or more forms of hemoglobin (e.g., oxygenated hemoglobin, sulfhemoglobin, methemoglobin, etc.) in order to enable differentiation in colors of fluid and/or color gradients of fluid associated with different forms of hemoglobin. However, the light source 318 may additionally or alternatively emit light of any suitable wavelengths corresponding to other types of blood component absorbance spectra.
In other variations, the insert 300 and/or light source 318 may be similar to any of the variations described in U.S. Patent Pub. 2015/0294461, entitled “METHOD FOR ESTIMATING A QUANTITY OF A BLOOD COMPONENT IN A FLUID CANISTER,” which is hereby incorporated in its entirety by this reference.
Internal Volume with Varying Dimensions
The internal volume of the receptacle may have varying dimensions along one or more axes, to help improve the analysis of fluids of having high or low concentrations of red blood cells (RBC) or hemoglobin (or other blood component).
As shown in
As shown in
The transition between the shallower and deeper sections of an internal volume 422a and/or 422b may be a smooth taper, as shown in
Processor
The system 100 may include or more processors 176 configured to evaluate images of fluid in the receptacle and estimate fluid-related information. The one or more processors 176 may be configured to execute instructions that are stored in memory such that, when it executes the instructions, the processor 176 performs aspects of the methods described herein. The instructions may be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware/firmware/software elements of a user computer or mobile device, wristband, smartphone, or any suitable combination thereof. The instructions may be stored on memory or other computer-readable medium such as RAMs, ROMs, flash memory, EEPROMs, optical devices (e.g., CD or DVD), hard drives, floppy drives, or any suitable device.
Generally, as further described below, the processor may transform the image of the fluid to a blood component concentration value by correlating the pixel color values of the fluid in the region to a blood component concentration (e.g., with template matching and/or parametric modeling techniques).
As shown in
Display
The display functions to display or otherwise communicate to a user (e.g., doctor, nurse) information that is generated by the system, including but not limited to patient information, images of the receptacle/fluid, and/or fluid-related information estimated as described herein. As shown in
The display 174 may be configured to display a user interface that enables the user to interact with displayed information. For example, the user interface may enable the user to select display options (e.g., font, color, language) and/or content (e.g., patient information, fluid-related information, alerts). The display may be user-interactive and include a resistive or capacitive touch screen that is responsive to skin, a stylet, or other user contact. In other examples, the display may be user-interactive via a cursor controlled by a mouse, keyboard, or other suitable user input device for receiving user commands.
The system may additionally or alternatively include an audio system that communicates fluid-related information to the user. The display and/or the audio system may provide alerts upon one or more estimations meeting a threshold (e.g., estimated quantity of fluids or blood component exceeds a threshold), which may be useful to prompt certain actions in response, such as providing a blood transfusion.
Other Variations
Other variations of systems for assessing fluids from a patient may be used in arrangements similar to those depicted in
Manifold Receptacle
In one variation, a system for assessing fluids from a patient may include a manifold receptacle. The manifold receptacle may be generally similar to the receptacle variations described above, except that the manifold receptacle is configured to be inserted into an inlet port of a sealed receptacle such as a waste management system. The manifold receptacle may be configured to be single-use and disposable after use during a surgical procedure.
Flow Divider
As shown in
Generally, a flow divider system 500 for assessing fluids from a patient may include: a receptacle 510 having an internal volume 522 for collecting fluids, and a bypass channel 516 extending between an inlet port 512 and an outlet port 514; and a flow divider 530 that diverts a first predetermined proportion of flow from the inlet port 512 into the internal volume 522 and a second predetermined portion of flow from the inlet port 512 into the bypass channel 516. Generally, the first predetermined proportion of flow into the internal volume 522 is smaller than the second predetermined portion of flow through the bypass channel 516, but in some variations the first and second predetermined proportions may be substantially equal or the first predetermined proportion of flow may be larger than the second predetermined portion of flow. Furthermore, the flow divider system 500 may include a camera and processor similar to those described above.
The internal volume 522 of the receptacle 510 in the system may generally be similar to any of the variations of internal volumes of receptacles described above (e.g., with reference to
The bypass channel 516 extends between an inlet port 512 configured to be in fluidic communication with a fluid retrieval device or other fluid source, and an outlet port 514 configured to be in fluidic communication with a second receptacle (e.g., waste management system). Additionally, the outlet port 514 may be coupled with a vacuum source, such as a vacuum source associated with a waste management system. Furthermore, in some variations, the inlet port 512 and/or outlet port 514 may include a valve that can be automatically and/or manually controlled to regulate flow in and out of the receptacle 510. For instance, the valves in inlet port 512 and outlet port 514 may be open such that fluid may flow into the internal volume 522 and bypass channel 516. In contrast, the valves may be closed to seal the contents of the receptacle 510. Such sealing may be useful, for example, before or after the surgical procedure for connection/disconnection from a fluid retrieval device and second receptacle, or during transport. As another example, the valves may be closed to allow a user (e.g., a nurse) to safely shake or agitate the receptacle 510 with lowered contamination risk, in order to achieve a more uniform mixing of contents of the receptacle prior to imaging the receptacle. Similarly, caps or other covers may be placed over the inlet port 512 and/or the outlet 514 to seal the contents of the receptacle 510.
The receptacle 520 may further define a first inner port 532 and a second inner port 534. The first inner port 532 is in fluidic communication with inlet port 512 and the internal volume 522, and functions to pass the first predetermined portion of flow from the inlet port 512 into the internal volume 522. The second inner port 534 is in fluidic communication with the outlet port 514 and the internal volume 522, and functions to pass suction from a vacuum source (coupled to the outlet port 514) into internal volume 522, thereby drawing fluids into the receptacle 510 though the inlet port 512.
The flow divider 530 may be located in the fluid path between (i) the inlet port 512 and (ii) the internal volume 522 and the bypass channel 516. The flow divider functions to consistently divide fluid flowing from inlet port 512 between the internal volume 522 and the bypass channel 516 according to a predetermined flow division ratio (e.g., about 1:20). In particular, the flow divider 530 diverts a first predetermined proportion of flow through first inner port 532 into the internal volume and a second predetermined proportion of flow into the bypass channel 516. For example, for a division ratio of about 1:20, for every one part of incoming fluid that the flow divider 530 diverts into the internal volume, the flow divider 530 may divert about twenty parts of incoming fluid into the bypass channel. However, the flow divider 530 may generally divide flow between the internal volume and the bypass channel according to any suitable flow division ratio.
In one variation, the flow divider 530 may accomplish consistently dividing fluids as a result of the ratio of an effective cross-sectional area of the first inner port 532 relative to the cross-sectional area of the bypass channel 516 (e.g., dimensionally and/or with use of a flow resistor). For example, the cross-sectional area of the first inner port 532 may be smaller than the cross-sectional area of the bypass channel 516, resulting in proportionately less flow diverted through the first inner port 532. As another example, the cross-sectional areas of the first inner port 532 and bypass channel 516 may be substantially similar, but the effective cross-sectional area of the first inner port 532 may be reduced further by a flow resistor (e.g., defining a narrow neck) placed in the first inner port 532.
The receptacle may include an anti-clotting agent, such as heparin. Clotted blood and hemolyzed red blood cells may exhibit different optical characteristics than unclotted blood and whole red blood cells. In view of this difference, an anti-clotting agent, which preserves the integrity of red blood cells collected in the receptacle over time, may help to obtain better quality images from which fluid-related information may be more accurately derived. For example, the internal walls of the internal volume may be coated with an anti-clotting agent, such that as fluid collects in the receptacle and rises up the walls of the internal volume, the fluid is exposed to additional amounts of anti-clotting agents to reduce hemolysis (and extracorporeal clotting) of red blood cells collected in the internal volume. As another example, the receptacle may include a reservoir of anti-clotting agent that can passively drip into the internal volume of the receptacle, and/or be selectively dispensed based on parameters such as volume or “redness” of accumulated fluid in the internal volume, volumetric flow rate of fluid accumulation in the internal volume, etc. Alternatively, the receptacle may include a hemolyzing agent instead of an anti-clotting agent in these arrangements, so as to fully hemolyze fluid in the internal volume, and image analysis (e.g., templates) may be adjusted for hemolyzed blood instead of non-hemolyzed blood.
Furthermore, the fluid divider system may include one or more components enabling fill and flush modes as described in detail above, but may alternatively omit any components operable in such distinct fill and flush modes.
III. Methods for Assessing Fluids from a Patient
Generally, a method for assessing fluids from a patient may be performed with use of a receptacle including an inlet port, an outlet port, and a third port. In some variations, as shown in
Additionally, for each image obtained, the method 600 may include evaluating the image 700 to estimate fluid volume and a blood component quantity in the receptacle, updating a total estimated volume of lost patient fluids 760, and updating a total estimated quantity of lost blood component 770. The method may include displaying some or all of the fluid-related information 780.
Collecting Fluids from the Patient
Collecting fluids from the patient into a receptacle 610 functions to accumulate a volume of lost patient fluids into the receptacle for evaluation. When collecting fluids (“fill” mode), the valve system may be adjusted to place the vacuum source, the receptacle, and a fluid retrieval device (or other fluid source) in fluidic communication. As a result, suction from the vacuum source may be routed throughout the system to draw fluids into the receptacle. For instance, as illustrated schematically in
Obtaining an Image
Obtaining an image of the collected fluids 630 functions to generate data which may be transformed into an estimate of blood volume and/or estimate of blood component concentration in the collected fluids. The image may include the entire receptacle or only a portion of the receptacle.
The image may be an optical image that is obtained with the aid of one or more features in the receptacle. For example, the image may capture a region of fluid having a substantially uniform thickness located between a fluid insert and a wall of the receptacle. As another example, the image may capture a region of fluid in which the fluid has a color gradient (e.g., due to a tapered surface of a fluid insert, walls of the receptacle, etc.).
In one variation, as shown in
In another variation, an image of the fluids may be obtained periodically or based on detection of intermediate threshold volumes of fluids in the receptacle. For example, an image of the fluids may be obtained every two seconds or five seconds. As another example, an image of the fluids may be obtained every time a fluid level sensor detects that an additional 5 mL has been added to the receptacle. Any suitable time increment and/or volume increment may be used to trigger image capture.
Draining the Collected Fluids
Upon detecting a high threshold volume of fluids in the receptacle 620 and/or obtaining an image of the collected fluids 630, the method includes draining the collected fluids from the receptacle 640. When draining fluids (“flush” mode), the valve system may be adjusted to place the vacuum source and the outlet port in fluidic communication. As a result, suction from the vacuum source may be routed to draw fluids out of the receptacle. For instance, as illustrated schematically in
To toggle from collecting fluids to draining fluids, the method may further include actuating a valve system. After being actuated to drain the collected fluids, the valve system may, at least in part, suspend fluidic communication between the vacuum source, the inlet port of the receptacle, and a fluid retrieval device (or other fluid source). Furthermore, after being actuated to drain the collected fluids, the valve system may open fluidic communication between the vacuum source and the outlet port of the receptacle. Additionally, actuating the valve system may involve opening the receptacle to ambient pressure, such as by actuating open a valve coupled to a fourth port of the receptacle.
In variations in which the valve system is automatically actuated, the method may include actuating the valve system based on a fluid level signal indicating a volume of fluids detected in the receptacle. Such actuation may involve, for example, activating an electromagnetic actuator such as a solenoid coupled to one or more valves. Alternatively, in variations in which the valve system is manually actuated, the method may include alerting a user to actuate the valve system.
Repeatedly Collecting and Draining
Upon detecting a low threshold volume of fluids in the receptacle 650 (or draining a sufficient amount of fluid from the receptacle), the method includes again collecting fluids from the patient in the receptacle 610. As shown in
To toggle from draining fluids to collecting fluids, similar to toggling from collecting fluids to draining fluids, the method may further include actuating a valve system. After being actuated to collect more fluids, the valve system may, at least in part, restore fluidic communication between the vacuum source, the inlet port of the receptacle, and the fluid retrieval device (or other fluid source). Furthermore, after being actuated to collect more fluids, the valve system may suspend fluidic communication between the vacuum source and the outlet port of the receptacle. Additionally, actuating the valve system may involve closing the receptacle to ambient pressure, such as by actuating closed the valve coupled to the fourth port of the receptacle.
Evaluating the Image
The method may include evaluating each image. As shown in
Processing
Processing the image may include normalizing the color characteristics of the image based on one or more optical fiducials (e.g., a color fiducial). Normalization may utilize the color fiducial to adjust for lighting conditions. For example, normalizing the image may include identifying a color fiducial captured in the image, determining an assigned color value associated with the identified color fiducial, and adjusting the image such that the color value of the color fiducial in the image substantially matches the assigned color value associated with the color fiducial. The assigned color value can, for example, be determined by looking up the color fiducial in a database (e.g., identified by code, position within a set of colored fiducial, position relative to a known feature of the receptacle, etc.). Adjustments to the image can include, for example, adjustment of exposure, contrast, saturation, temperature, tint, etc. Evaluating the image 700 may then proceed using the adjusted image.
Processing the image may additionally or alternatively include retrieving receptacle-related information associated with one or more optical fiducials and associating the image with the receptacle-related information. The optical fiducial may be scanned from the receptacle or manually entered into settings for the image analysis, and may be used to identify receptacle-related information. Retrieving receptacle-related information may be performed before, after, or during the obtaining of the image. Some or all of the receptacle-related information may be used when proceeding with evaluating the image 700.
Identifying a Receptacle Image Region
Identifying a receptacle image region 720 functions to identify a portion of the image whose pixel color values will be transformed into a blood component concentration. The receptacle image region may include the entire receptacle in the image, or only a portion of the receptacle corresponding to an identified volume of fluid. For example, the boundaries or outline of the receptacle image region may be detected using edge detection techniques, such as based on a pattern of pixels having biased red pixel color values (which suggests presence of blood) and other pixels without biased red pixel color values (which suggests absence of blood). As another example, the boundaries of the receptacle image region may be detected based on optical fiducials (e.g., coupled to the surface of the receptacle). In other examples, the boundaries of the receptacle image region may be detected using template matching techniques and/or other machine vision techniques. Once the receptacle image region is detected, all areas other than the receptacle image region may be cropped out or otherwise disregarded.
Estimating Blood Component Concentration and Quantity
Evaluation of the images may include estimating a blood component concentration 730. The blood component may be red blood cells (e.g., by volume) or hemoglobin, but may additionally or alternatively include other suitable components of blood. The estimation of blood component concentration may be based on various template matching techniques and/or parametric modeling techniques, as described below.
Template Matching and Parametric Modeling Techniques
For instance, to convert pixel color values in the receptacle image region to a blood component concentration, template matching techniques may include comparing a redness intensity of the receptacle image region against redness intensity from template images (e.g., a training set, samples analyzed previously). Each template image may be contained within a library of template images, and may be associated with a known blood, hemoglobin, red blood cell mass or volume, and/or other fluid characteristics. Generally, where the redness intensity of the receptacle image region is substantially similar to (and is paired with) a closest-matching template image, the receptacle image region may be estimated as depicting the same blood component concentration as the closest-matching template image.
In one example, K-nearest neighbor methods may be used for the template matching. More specifically, a K-nearest neighbor method may be used to compare the redness intensity of the receptacle image region with redness intensity values in the template images. Additionally or alternatively, a K-nearest neighbor method may be used to compare greenness intensity and/or a blueness intensity (e.g., in conjunction with a redness intensity) of pixels in the receptacle image region with greenness and/or blueness intensity values of the template images. Thus, the receptacle image region may be paired with the closest-matching template image identified with the K-nearest neighbor method, and the receptacle image region may be estimated as depicting the same blood component concentration associated with the closest-matching template image.
In another example, absolute differences in pixel intensities (e.g., in red, green, and/or blue intensities or color values) may be used for the template matching. Such an absolute difference in pixel intensities may be calculated at a wavelength of light that correlates with the blood component (e.g., at about 400 nm for estimating hemoglobin concentration). More specifically, a sum of absolute differences in pixel intensities may be used to compare pixel intensities between the receptacle image region and each template image. The closest-matching template image is identified when the sum of absolute differences is substantially minimal compared to other sums of absolute differences calculated for the receptacle image region and other template images. Thus, the receptacle image region may be paired with the closest-matching template image identified with the sum of absolute differences method, and the receptacle image region may be estimated as depicting the same blood component concentration associated with the closest-matching template image.
Additionally, parametric models may be used to convert pixel color values in the receptacle image region to a blood component concentration. Generally, color values of the template images may be used to train or generate a parametric model (mathematical function, curve, or algorithm etc.) that correlates a pixel color value to a blood component concentration. The parametric model may take an input of pixel intensities or color values (e.g., from the receptacle image region) and converted it into an output of estimated blood component concentration value.
Additionally or alternatively, the method may employ techniques such as those described in U.S. Pat. No. 8,792,693 filed Jul. 9, 2012 and entitled “SYSTEM AND METHOD FOR ESTIMATING EXTRACORPOREAL BLOOD VOLUME IN A PHYSICAL SAMPLE” and U.S. Pat. No. 8,983,167 filed Jan. 10, 2013 and entitled “SYSTEM AND METHOD FOR ESTIMATING A QUANTITY OF A BLOOD COMPONENT IN A FLUID CANISTER,” each of which is hereby incorporated in its entirety by this reference. As another example, a parametric model similar to that depicted in
Variations
In one variation, the entire receptacle image region may be compared to a set of template images. The template images may capture exemplary receptacles containing different known concentrations of the blood component. When a particular template image is identified as a match (e.g., having pixel color values that are substantially similar to those in the receptacle image region), the fluid in the receptacle may be assumed to have a blood component concentration equal to the known blood component concentration associated with the matched template image.
In another variation, the receptacle image region may be divided in multiple subregions (i.e., pixel or pixel clusters), each of which may be compared to a set of template color values. Each template color value may be associated with a respective blood component concentration value or range of values. For instance, estimating the blood component concentration may include dividing the receptacle image region into multiple subregions (e.g., arranged in a grid), determining a representative pixel color value for each subregion (e.g., by averaging all pixel color values for each subregion), correlating each subregion with a blood component concentration value based on a comparison between the representative pixel color value and a set of template color values having associated blood component concentration values, and combining the blood component concentration values for the subregions to generate single composite blood component concentration representative of the receptacle image region (e.g., by averaging the subregion blood component concentration values). Another similar variation may use a parametric model, instead of template images, to correlate the representative pixel color value with a blood component concentration value for each subregion.
In another variation, in which the fluid in the receptacle has a color gradient (e.g., because the receptacle includes a slope), estimating the blood component concentration may involve matching the color gradient (i.e., distribution of pixel color values) in the receptacle image region with a set of template images of known blood component concentration. Similar to the variation described above, the template images may capture exemplary color gradients in fluid with known blood component concentrations.
In another variation, in which the fluid in the receptacle has a color gradient, estimating the blood component concentration may involve identifying the fluid volume thickness (as measured along the camera optical axis) corresponding to each subregion in the receptacle image region, determining a representative pixel color value for each subregion, applying a parametric model to each subregion to correlate the representative pixel color value and the fluid volume thickness for the subregion with a blood component concentration, and combining the blood component concentrations for the subregions into a single composite blood component concentration representative of the receptacle image region.
In yet another variation, the blood component concentration can generally be classified as high or low by comparing the redness intensity of at least some of the pixels in the receptacle image region with a threshold value. For example, blood component concentration may be classified as high if the redness intensity of pixels corresponding to the shallowest or thinnest region of fluid (as measured along the camera optical axis) in the receptacle exceeds a predetermined threshold. In contrast, blood component concentration may be classified as low if the redness intensity of pixels corresponding to the deepest or thickest region of fluid (as measured along the camera optical axis) in the receptacle less than a predetermined threshold. Furthermore, in another variations, the redness intensity at the shallowest/thinnest region or the deepest/thickest region of fluid (as measured along the camera optical axis) may be used as representative pixel color values for the entire receptacle image region and correlated to a blood component concentration based on template matching and/or parametric modeling techniques.
Estimating Volume of Fluids in the Receptacle
Evaluation of the images may include estimating a volume of fluids in the receptacle 740. For example, the size of a receptacle image region (which has been cropped to isolate biased red pixels) may be correlated to an estimated volume. Other edge detection techniques, template matching techniques, and/or parametric modeling techniques may be used to estimate fluid volume in the receptacle. Alternatively, in instances in which images are captured when fluid level sensors indicate the fluid volume in the receptacle has met a high threshold volume value, estimating a volume of fluids in the receptacle by evaluating the images may not be necessary, since the fluid volume may be assumed to be equal to the high threshold volume value.
Estimating Quantity of the Blood Component
Evaluation of the images may include estimating a quantity of the blood component in the receptacle 750. The quantity of blood component may be based on the estimated concentration of the blood component in the receptacle and the estimated volume of fluids in the receptacle. For example, the volume of the blood component may be estimated by multiplying values for the concentration of the blood component and the volume of fluids in the receptacle. Other quantitative metrics, such as mass or weight, may be derived from the estimated volume of the blood component.
Updating Database
The method may include updating a total estimated volume of lost patient fluids 750, by summing the previous intermittent estimated volumes of fluids that have filled and drained from the receptacle. Similarly, the method may include updating a total estimated volume of lost blood component 760 by summing the previous intermittent estimated quantities of blood component lost by the patient. The updated total estimates may, for example, be stored in local memory on a handheld or mobile device or other computing device, communicated to a server or database for remote storage, etc. The update may occur during the surgical procedure (e.g., after each time a volume of fluids is estimated, or periodically such as every five seconds) to provide an estimate of cumulative or total blood loss and/or of cumulative or total blood component loss. Additionally or alternatively, the update may occur at the conclusion of the surgical procedure. For example, as shown in
Displaying
The method may include displaying some or all of the fluid-related information 780 (e.g., total estimated volume of lost patient fluids, total estimated quantity of lost blood component, etc.) on a display such as a monitor. The display may reflect, on a substantially real-time basis, the estimated metrics as they are updated throughout and/or after the surgical procedure. Additionally, the method may include displaying some or all of the images of the receptacle/fluid as they are captured, alerts to the user (e.g., when estimated total volume of lost patient fluids or total estimated quantity of lost blood component exceeds a threshold) and/or other suitable information.
Other Variations
As shown in
Portions of method 900 may be substantially similar to similarly-named processes of method 600 described above. For example, evaluating the image 940 may be substantially similar to evaluating the image 700. However, estimating total volume of lost fluids (Vblood, tot) and total quantity of lost blood component 950 (QBC, tot) may be particular to methods using a flow divider system. Since the patient fluid in the receptacle is a representative sample of all patient fluid collected, assessments of patient fluid in the receptacle may be projected or extended to provide assessments of the total patient fluid collected by the fluid retrieval device (or from another fluid source). More specifically, the method may include estimating fluid volume that was discarded (VBlood, discard) by multiplying the flow division ratio and the estimated fluid volume in the receptacle (VBlood, rec). Similarly, the method may include estimating blood component quantity that was discarded (QBC, discard) by multiplying the flow division ratio and the estimated blood component quantity in the receptacle (QBC, rec). Finally, total volume of lost fluids (VBlood, tot) can be estimated as the sum of estimated fluid volume in the receptacle and estimated fluid volume that was discarded. Similarly, total quantity of lost blood component (QBC, tot) can be estimated as the sum of estimated blood component in the receptacle and estimated fluid volume that was discarded. This estimation may be summarized as:
VBlood,tot=VBlood,rec+VBlood,discard=VBlood,rec+(ratio)(VBlood,rec) (1)
QBC,tot=QBC,rec+QBC,discard=QBC,rec+(ratio)(QBC,rec) (2)
An example of estimating total volume of lost fluids (VBlood, tot) is illustrated schematically in the method 1000 in
IV. Kits
A kit may include any part of the systems described herein. In further aspects, a kit may additionally or alternatively include a tangible non-transitory computer readable medium having computer-executable (readable) program code embedded thereon that may provide instructions for causing one or more processors, when executing the instructions, to perform one or more of the methods for assessing fluids from a patient as described herein. The kit may include instructions for use of at least some of its components, including but not limited to: instructions for installation, use, and/or care of the receptacle, instructions for installing the computer-executable (readable) program code with instructions embedded thereon, etc.
As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to the described and illustrated embodiments without departing from the scope of the invention. Furthermore, different variations of the methods and systems include various combinations and permutations of the steps and other elements described herein.
This application claims priority to U.S. Provisional Patent Application No. 62/162,117, filed on May 15, 2015, entitled “SYSTEMS AND METHODS FOR TRACKING PATIENT BLOOD LOSS”, which is hereby incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
2707955 | Borden | May 1955 | A |
3182252 | Den Berg | May 1965 | A |
3199507 | Kamm | Aug 1965 | A |
3367431 | Baker | Feb 1968 | A |
3646938 | Haswell | Mar 1972 | A |
3687209 | Goldberg et al. | Aug 1972 | A |
3832135 | Chlupsa et al. | Aug 1974 | A |
3863724 | Dalia et al. | Feb 1975 | A |
3864571 | Stillman et al. | Feb 1975 | A |
3948390 | Ferreri | Apr 1976 | A |
4105019 | Haswell | Aug 1978 | A |
4149537 | Haswell | Apr 1979 | A |
4244369 | McAvinn et al. | Jan 1981 | A |
4402373 | Comeau | Sep 1983 | A |
4422548 | Cheesman et al. | Dec 1983 | A |
4429789 | Puckett | Feb 1984 | A |
4512431 | Bloomfield | Apr 1985 | A |
4562842 | Morfeld et al. | Jan 1986 | A |
4583546 | Garde | Apr 1986 | A |
4642089 | Zupkas | Feb 1987 | A |
4681571 | Nehring | Jul 1987 | A |
4773423 | Hakky | Sep 1988 | A |
4784267 | Gessler et al. | Nov 1988 | A |
4832198 | Alikhan | May 1989 | A |
4917694 | Jessup | Apr 1990 | A |
4922922 | Pollock et al. | May 1990 | A |
4961533 | Teller et al. | Oct 1990 | A |
5014798 | Glynn | May 1991 | A |
5029584 | Smith | Jul 1991 | A |
5031642 | Nosek | Jul 1991 | A |
5048683 | Westlake | Sep 1991 | A |
5119814 | Minnich | Jun 1992 | A |
5119830 | Davis | Jun 1992 | A |
5132087 | Manion et al. | Jun 1992 | A |
5128036 | Svensson | Jul 1992 | A |
5190059 | Fabian et al. | Mar 1993 | A |
5231032 | Ludvigsen | Jul 1993 | A |
5236664 | Ludvigsen | Aug 1993 | A |
5285682 | Micklish | Feb 1994 | A |
5348533 | Papillon et al. | Sep 1994 | A |
5369713 | Schwartz et al. | Nov 1994 | A |
5458566 | Herrig et al. | Oct 1995 | A |
5492537 | Vancaillie | Feb 1996 | A |
5522805 | Vancaillie et al. | Jun 1996 | A |
5568262 | LaChapelle et al. | Oct 1996 | A |
5595456 | Berg et al. | Jan 1997 | A |
5629498 | Pollock et al. | May 1997 | A |
5633166 | Westgard et al. | May 1997 | A |
5646788 | Bietry | Jul 1997 | A |
5650596 | Morris et al. | Jul 1997 | A |
5709670 | Vancaillie et al. | Jan 1998 | A |
5774865 | Glynn | Jun 1998 | A |
5807358 | Herweck et al. | Sep 1998 | A |
5851835 | Groner | Dec 1998 | A |
5923001 | Morris et al. | Jul 1999 | A |
5931824 | Stewart et al. | Aug 1999 | A |
5944668 | Vancaillie et al. | Aug 1999 | A |
5956130 | Vancaillie et al. | Sep 1999 | A |
5971948 | Pages et al. | Oct 1999 | A |
5984893 | Ward | Nov 1999 | A |
5996889 | Fuchs et al. | Dec 1999 | A |
6006119 | Soller et al. | Dec 1999 | A |
6061583 | Ishihara et al. | May 2000 | A |
6294999 | Yarin et al. | Sep 2001 | B1 |
6359683 | Berndt | Mar 2002 | B1 |
6510330 | Enejder | Jan 2003 | B1 |
6641039 | Southard | Nov 2003 | B2 |
6699231 | Sterman et al. | Mar 2004 | B1 |
6704500 | Takematsu | Mar 2004 | B2 |
6728561 | Smith et al. | Apr 2004 | B2 |
6730054 | Pierce et al. | May 2004 | B2 |
6777623 | Ballard | Aug 2004 | B2 |
6998541 | Morris et al. | Feb 2006 | B2 |
7001366 | Ballard | Feb 2006 | B2 |
7112273 | Weigel et al. | Sep 2006 | B2 |
7147626 | Goodman et al. | Dec 2006 | B2 |
7158030 | Chung | Jan 2007 | B2 |
7180014 | Farber et al. | Feb 2007 | B2 |
7274947 | Koo et al. | Sep 2007 | B2 |
7297834 | Shapiro | Nov 2007 | B1 |
7299981 | Hickle et al. | Nov 2007 | B2 |
7364545 | Klein | Apr 2008 | B2 |
7384399 | Ghajar | Jun 2008 | B2 |
7430047 | Budd et al. | Sep 2008 | B2 |
7430478 | Fletcher-Haynes et al. | Sep 2008 | B2 |
7469727 | Marshall | Dec 2008 | B2 |
7499581 | Tribble et al. | Mar 2009 | B2 |
7557710 | Sanchez et al. | Jul 2009 | B2 |
7641612 | Mccall | Jan 2010 | B1 |
D611731 | Levine | Mar 2010 | S |
7670289 | McCall | Mar 2010 | B1 |
7703674 | Stewart et al. | Apr 2010 | B2 |
7708700 | Ghajar | May 2010 | B2 |
7711403 | Jay et al. | May 2010 | B2 |
7749217 | Podhajsky | Jul 2010 | B2 |
7795491 | Stewart et al. | Sep 2010 | B2 |
7819818 | Ghajar | Oct 2010 | B2 |
7909806 | Goodman et al. | Mar 2011 | B2 |
7966269 | Bauer et al. | Jun 2011 | B2 |
7995816 | Roger et al. | Aug 2011 | B2 |
8025173 | Michaels | Sep 2011 | B2 |
8105296 | Morris et al. | Jan 2012 | B2 |
8181860 | Fleck et al. | May 2012 | B2 |
8194235 | Kosaka et al. | Jun 2012 | B2 |
8241238 | Hiruma et al. | Aug 2012 | B2 |
8279068 | Morris et al. | Oct 2012 | B2 |
8398546 | Pacione et al. | Mar 2013 | B2 |
8472693 | Davis et al. | Jun 2013 | B2 |
8479989 | Fleck et al. | Jul 2013 | B2 |
8576076 | Morris et al. | Nov 2013 | B2 |
8626268 | Adler et al. | Jan 2014 | B2 |
8693753 | Nakamura | Apr 2014 | B2 |
8704178 | Pollock et al. | Apr 2014 | B1 |
8792693 | Satish et al. | Jul 2014 | B2 |
8797439 | Coley et al. | Aug 2014 | B1 |
8897523 | Satish et al. | Nov 2014 | B2 |
8983167 | Satish et al. | Mar 2015 | B2 |
9047663 | Satish et al. | Jun 2015 | B2 |
9171368 | Satish et al. | Oct 2015 | B2 |
9595104 | Satish et al. | Mar 2017 | B2 |
9646375 | Satish et al. | May 2017 | B2 |
9652655 | Satish et al. | May 2017 | B2 |
9773320 | Satish et al. | Sep 2017 | B2 |
9936906 | Satish et al. | Apr 2018 | B2 |
9981790 | Ost | May 2018 | B1 |
20020124017 | Mault | Sep 2002 | A1 |
20030069509 | Matzinger et al. | Apr 2003 | A1 |
20030095197 | Wheeler et al. | May 2003 | A1 |
20030130596 | Von Der Goltz | Jul 2003 | A1 |
20040031626 | Morris et al. | Feb 2004 | A1 |
20040129678 | Crowley et al. | Jul 2004 | A1 |
20050051466 | Carter et al. | Mar 2005 | A1 |
20050163354 | Ziegler | Jul 2005 | A1 |
20050209585 | Nord et al. | Sep 2005 | A1 |
20050265996 | Lentz | Dec 2005 | A1 |
20060058593 | Drinan et al. | Mar 2006 | A1 |
20060178578 | Tribble et al. | Aug 2006 | A1 |
20060224086 | Harty | Oct 2006 | A1 |
20060241453 | Nguyen-Dinh et al. | Oct 2006 | A1 |
20070004959 | Carrier et al. | Jan 2007 | A1 |
20070008622 | Sommer | Jan 2007 | A1 |
20070108129 | Mori et al. | May 2007 | A1 |
20070243137 | Hainfeld | Oct 2007 | A1 |
20070287182 | Morris et al. | Dec 2007 | A1 |
20080029416 | Paxton | Feb 2008 | A1 |
20080030303 | Kobren et al. | Feb 2008 | A1 |
20080045845 | Pfeiffer et al. | Feb 2008 | A1 |
20080194906 | Mahony et al. | Aug 2008 | A1 |
20090076470 | Ryan | Mar 2009 | A1 |
20090257632 | Lalpuria et al. | Oct 2009 | A1 |
20090310123 | Thomson | Dec 2009 | A1 |
20090317002 | Dein | Dec 2009 | A1 |
20100003714 | Bachur | Jan 2010 | A1 |
20100007727 | Torre-Bueno | Jan 2010 | A1 |
20100025336 | Carter et al. | Feb 2010 | A1 |
20100027868 | Kosaka et al. | Feb 2010 | A1 |
20100066996 | Kosaka et al. | Mar 2010 | A1 |
20100087770 | Bock | Apr 2010 | A1 |
20100150759 | Mazur et al. | Jun 2010 | A1 |
20100280117 | Patrick et al. | Nov 2010 | A1 |
20110066182 | Falus | Mar 2011 | A1 |
20110118647 | Paolini et al. | May 2011 | A1 |
20110144595 | Cheng | Jun 2011 | A1 |
20110192745 | Min | Aug 2011 | A1 |
20110196321 | Wudyka | Aug 2011 | A1 |
20110200239 | Levine et al. | Aug 2011 | A1 |
20110275957 | Bhandari | Nov 2011 | A1 |
20110305376 | Neff | Dec 2011 | A1 |
20110316973 | Miller et al. | Dec 2011 | A1 |
20120000297 | Hashizume et al. | Jan 2012 | A1 |
20120064132 | Aizawa et al. | Mar 2012 | A1 |
20120065482 | Robinson et al. | Mar 2012 | A1 |
20120127290 | Tojo et al. | May 2012 | A1 |
20120210778 | Palmer et al. | Aug 2012 | A1 |
20120257188 | Yan et al. | Oct 2012 | A1 |
20120262704 | Zahniser et al. | Oct 2012 | A1 |
20120271170 | Emelianov et al. | Oct 2012 | A1 |
20120309636 | Gibbons et al. | Dec 2012 | A1 |
20120327365 | Makihira | Dec 2012 | A1 |
20130010094 | Satish et al. | Jan 2013 | A1 |
20130094996 | Janssenswillen | Apr 2013 | A1 |
20130170729 | Wardlaw et al. | Jul 2013 | A1 |
20130245599 | Williams et al. | Sep 2013 | A1 |
20130301901 | Satish et al. | Nov 2013 | A1 |
20130303870 | Satish et al. | Nov 2013 | A1 |
20130305820 | Granstrand | Nov 2013 | A1 |
20130308852 | Hamsici et al. | Nov 2013 | A1 |
20140063180 | Sharma | Mar 2014 | A1 |
20140079297 | Tadayon et al. | Mar 2014 | A1 |
20140128838 | Satish et al. | May 2014 | A1 |
20140207091 | Heagle et al. | Jul 2014 | A1 |
20140330094 | Pacione et al. | Nov 2014 | A1 |
20150294460 | Satish et al. | Oct 2015 | A1 |
20150294461 | Satish et al. | Oct 2015 | A1 |
20150310634 | Babcock et al. | Oct 2015 | A1 |
20150354780 | Wang | Dec 2015 | A1 |
20160015602 | Panzini | Jan 2016 | A1 |
20160027173 | Satish et al. | Jan 2016 | A1 |
20160123998 | MacIntyre et al. | May 2016 | A1 |
20160228639 | Zin | Aug 2016 | A1 |
20160243314 | Olive | Aug 2016 | A1 |
20160327427 | Briones et al. | Nov 2016 | A1 |
20170011276 | Mehring et al. | Jan 2017 | A1 |
20170023446 | Rietveld et al. | Jan 2017 | A1 |
20170184442 | Satish et al. | Jun 2017 | A1 |
20170189621 | Olive et al. | Jul 2017 | A1 |
20170351894 | Satish et al. | Dec 2017 | A1 |
20170352152 | Satish et al. | Dec 2017 | A1 |
20180104681 | Lee et al. | Apr 2018 | A1 |
20180154088 | Broselow | Jun 2018 | A1 |
20190008427 | Satish et al. | Jan 2019 | A1 |
Number | Date | Country |
---|---|---|
2870635 | Oct 2013 | CA |
2870635 | Oct 2013 | CA |
101505813 | Aug 2009 | CN |
101505813 | Aug 2009 | CN |
102009007733 | Aug 2010 | DE |
S-59-161801 | Oct 1984 | JP |
S59161801 | Oct 1984 | JP |
S-61-176357 | Aug 1986 | JP |
62144652 | Jun 1987 | JP |
S-62-144652 | Jun 1987 | JP |
S62144652 | Sep 1987 | JP |
H-06-510210 | Nov 1994 | JP |
H06510210 | Nov 1994 | JP |
H-07-308312 | Nov 1995 | JP |
1137845 | Feb 1999 | JP |
H-11-37845 | Feb 1999 | JP |
2000-227390 | Aug 2000 | JP |
2002-331031 | Nov 2002 | JP |
2002331031 | Nov 2002 | JP |
2003-075436 | Mar 2003 | JP |
2003075436 | Mar 2003 | JP |
2005-052288 | Mar 2005 | JP |
2005052288 | Mar 2005 | JP |
3701031 | Sep 2005 | JP |
3701031 | Sep 2005 | JP |
2006-280445 | Oct 2006 | JP |
2006280445 | Oct 2006 | JP |
2008-055142 | Mar 2008 | JP |
2008055142 | Mar 2008 | JP |
2008-519604 | Jun 2008 | JP |
2009-535639 | Oct 2009 | JP |
2010-516429 | May 2010 | JP |
2011-036371 | Feb 2011 | JP |
2011036371 | Feb 2011 | JP |
2011-515681 | May 2011 | JP |
2011515681 | May 2011 | JP |
2011-252804 | Dec 2011 | JP |
WO-9217787 | Oct 1992 | WO |
WO-9217787 | Oct 1992 | WO |
WO-1996039927 | Dec 1996 | WO |
WO-9639927 | Dec 1996 | WO |
WO-9710856 | Mar 1997 | WO |
WO-9710856 | Mar 1997 | WO |
WO-2006053208 | May 2006 | WO |
WO-2007129948 | Nov 2007 | WO |
WO-2008094703 | Aug 2008 | WO |
WO-2008094703 | Aug 2008 | WO |
WO-2009117652 | Sep 2009 | WO |
WO-2009117652 | Sep 2009 | WO |
WO-2011019576 | Feb 2011 | WO |
WO-2011019576 | Feb 2011 | WO |
WO-2011145351 | Nov 2011 | WO |
WO-2013009709 | Jan 2013 | WO |
WO-2013009709 | Jan 2013 | WO |
WO-2013009709 | Jan 2013 | WO |
WO-2013172874 | Nov 2013 | WO |
WO-2013173356 | Nov 2013 | WO |
WO-2013172874 | Nov 2013 | WO |
WO-2013173356 | Nov 2013 | WO |
WO-2014013213 | Jan 2014 | WO |
WO-2013009709 | May 2014 | WO |
WO-2015161003 | Oct 2015 | WO |
WO-2015161003 | Oct 2015 | WO |
WO-2016187071 | Nov 2016 | WO |
WO-2017111324 | Jun 2017 | WO |
WO-2017112913 | Jun 2017 | WO |
Entry |
---|
Extended European Search Report dated Sep. 18, 2017, for EP Application No. 15 780 590.4, filed on Apr. 15, 2015, 8 pages. |
Non-Final Office Action dated Apr. 11, 2018, for U.S. Appl. No. 15/416,986, filed Jan. 26, 2017, 6 pages. |
Non-Final Office Action dated Jul. 13, 2018, for U.S. Appl. No. 15/389,365, filed Dec. 22, 2016, 14 pages. |
U.S. Appl. No. 15/943,561, filed Apr. 2, 2018, by Satish et al. |
ACOG (2012). “Optimizing protocols in obstetrics,” Series 2, 25 total pages. |
Adkins, A.R. et al. (2014). “Accuracy of blood loss estimations among anesthesia providers,” AANA Journal 82(4):300-306. |
Aklilu, A. Gauss Surgical Measures Blood Loss with a Smartphone. Jun. 14, 2012.<http://www.health2con.com/news/2012/06/14/gauss-surgical-measures-blood-loss-with-a-smartphone/>, 6 pages. |
Al-Kadri, H.M. et al. (2014). “Effect of education and clinical assessment on the accuracy of post partum blood loss estimation,” BMC Preg. Childbirth 14:110, 7 total pages. |
AWHONN Practice Brief (2014). “Quantification of blood loss: AWHONN practice brief number 1,” AWHONN p. 1-3. |
Bellad, M.B. et al. (2009). “Standardized Visual Estimation of Blood Loss during Vaginal Delivery with Its Correlation Hematocrit Changes—A Descriptive Study.” South Asian Federation of Obstetrics and Gynecology 1:29-34. |
Bose, P. et al. (2006). “Improving the accuracy of estimated blood loss at obstetric haemorrhage using clinical reconstructions,” BJOG 113(8):919-924. |
Eipe, N. et al. (2006). “Perioperative blood loss assessment—How accurate?” Indian J. Anaesth. 50(1):35-38. |
Extended European Search Report dated Apr. 1, 2015, for EP Application No. 12 810 640.8, filed on Jul. 9, 2012, 8 pages. |
Extended European Search Report dated Nov. 23, 2015, for EP Application No. 13 790 688.9, filed on May 14, 2013, 9 pages. |
Extended European Search Report dated Nov. 17, 2015, for EP Application No. 13 790 449.6, filed on Jan. 10, 2013, 8 pages. |
Extended European Search Report dated Nov. 4, 2016, for EP Application No. 16 183 350.4, filed on Jul. 9, 2012, 9 pages. |
Final Office Action dated Feb. 12, 2016, for U.S. Appl. No. 13/544,664, filed Jul. 9, 2012, 9 pages. |
Final Office Action dated Aug. 26, 2016, for U.S. Appl. No. 13/894,054, filed May 14, 2013, 7 pages. |
Final Office Action dated Jul. 26, 2016, for U.S. Appl. No. 14/876,628, filed Oct. 6, 2015, 5 pages. |
Habak, P.J. et al. (2016). “A comparison of visual estimate versus calculated estimate of blood loss at vaginal delivery,” British J. Med. Medical Res. 11(4):1-7. |
Holmes, A.A. et al. (2014). “Clinical evaluation of a novel system for monitoring surgical hemoglobin loss,” Anesth. Analg. 119(3):588-594. |
International Search Report dated Sep. 17, 2012, for PCT Application No. PCT/US2012/045969, filed on Jul. 9, 2012, 2 pages. |
International Search Report dated Sep. 24, 2013, for PCT Application No. PCT/US2013/040976, filed on May 14, 2013, 2 pages. |
International Search Report dated Mar. 26, 2013, for PCT Application No. PCT/US2013/021075, filed on Jan. 10, 2013, 2 pages. |
International Search Report dated Jul. 8, 2015, for PCT Application No. PCT/US2015/026042, filed on Apr. 15, 2015, 2 pages. |
International Search Report dated Aug. 18, 2016, for PCT Application No. PCT/US2016/032561, filed on May 13, 2016, 2 pages. |
International Search Report dated Mar. 8, 2017, for PCT Application No. PCT/US2016/068452, filed on Dec. 22, 2016, 3 pages. |
Jones, R. (2015). “Quantitative measurement of blood loss during delivery,” AWHONN p. S41. |
Kamiyoshihara, M. et al. (2008). “The Utility of an Autologous Blood Salvage System in Emergency Thoracotomy for a Hemothorax After Chest Trauma,” Gen. Thorac. Cardiovasc. Surg. 56:222. |
Lyndon, A. et al. (2010). “Blood loss: Clinical techniques for ongoing quantitative measurement,” CMQCC Obstetric Hemorrhage Toolkit, pp. 1-7. |
Lyndon, A. et al. (2015). “Cumulative quantitative assessment of blood loss,” CMQCC Obstetric Hemorrhage Toolkit Version 2.0, pp. 80-85. |
Manikandan, D. et al. (2015). “Measurement of blood loss during adenotonsillectomy in children and factors affecting it,” Case Reports in Clinical Medicine 4:151-156. |
Merck for Mother's Program (2012). Blood loss measurement: Technology opportunity assessment, 9 total pages. |
Non-Final Office Action dated Aug. 13, 2015, for U.S. Appl. No. 13/544,664, filed Jul. 9, 2012, 8 pages. |
Non-Final Office Action dated Aug. 2, 2016, for U.S. Appl. No. 13/544,664, filed Jul. 9, 2012, 6 pages. |
Non-Final Office Action dated May 9, 2014, for U.S. Appl. No. 13/544,679, filed Jul. 9, 2012, 7 pages. |
Non-Final Office Action dated Mar. 30, 2016, for U.S. Appl. No. 13/894,054, filed May 14, 2013, 9 pages. |
Non-Final Office Action dated Sep. 5, 2014, for U.S. Appl. No. 13/738,919, filed Jan. 10, 2013, 8 pages. |
Non-Final Office Action dated Mar. 20, 2015, for U.S. Appl. No. 14/613,807, filed Feb. 4, 2015, 8 pages. |
Non-Final Office Action dated Dec. 15, 2015, for U.S. Appl. No. 14/876,628, filed Oct. 6, 2015, 8 pages. |
Non-Final Office Action dated Mar. 24, 2017, for U.S. Appl. No. 14/687,862, filed Apr. 15, 2015, 22 pages. |
Non-Final Office Action dated Apr. 20, 2017, for U.S. Appl. No. 13/894,054, filed May 14, 2013, 7 pages. |
Notice of Allowance dated May 12, 2014, for U.S. Appl. No. 13/544,646, filed Jul. 9, 2012, 10 pages. |
Notice of Allowance dated Sep. 3, 2014, for U.S. Appl. No. 13/544,679, filed Jul. 9, 2012, 8 pages. |
Notice of Allowance dated Nov. 10, 2014, for U.S. Appl. No. 13/738,919, filed Jan. 10, 2013, 10 pages. |
Notice of Allowance dated Jun. 25, 2015, for U.S. Appl. No. 14/613,807, filed Feb. 4, 2015, 10 pages. |
Notice of Allowance dated Oct. 26, 2016, for U.S. Appl. No. 14/876,628, filed Oct. 6, 2015, 11 pages. |
Notice of Allowance dated Feb. 15, 2017, for U.S. Appl. No. 13/544,664, filed Jul. 9, 2012, 10 pages. |
Notice of Allowance dated Aug. 8, 2017, for U.S. Appl. No. 14/687,862, filed Apr. 15, 2015, 6 pages. |
Pogorelc, D. iPads in the OR: New Mobile Platform to Monitor Blood Loss During Surgery. MedCityNews, Jun. 6, 2012. http://medcitynews.com/2012/06/ipads-in-the-or-new-mobile-platform-to-monitor-blood-loss-during-surgery, 2 pages. |
Roston, A.B. et al. (2012). “Chapter 9: Blood loss: Accuracy of visual estimation,” in A comprehensive textbook of postpartum hemorrhage: An essential clinical reference for effective management, 2nd edition, Sapiens publishing, pp. 71-72. |
Sant et al. (2012). “Exsanguinated Blood Volume Estimation Using Fractal Analysis of Digital Images,” Journal of Forensic Sciences 57:610-617. |
Schorn, M.N. (2010). “Measurement of blood loss: Review of the literature,” J. Midwifery and Women's Health 55(1):20-27. |
Sukprasert, M. et al. (2006). “Increase accuracy of visual estimation of blood loss from education programme,” J. Med. Assoc. Thai 89(suppl. 4):S54-S59. |
Written Opinion of the International Searching Authority dated Sep. 17, 2012, for PCT Application No. PCT/US2012/045969, filed on Jul. 9, 2012, 4 pages. |
Written Opinion of the International Searching Authority dated Sep. 24, 2013, for PCT Application No. PCT/US2013/040976, filed on May 14, 2013, 4 pages. |
Written Opinion of the International Searching Authority dated Mar. 26, 2013, for PCT Application No. PCT/US2013/021075, filed on Jan. 10, 2013, 6 pages. |
Written Opinion of the International Searching Authority dated Jul. 8, 2015, for PCT Application No. PCT/US2015/026042, filed on Apr. 15, 2015, 4 pages. |
Written Opinion of the International Searching Authority mailed on Aug. 18, 2016, for PCT Application No. PCT/US2016/032561, filed on May 13, 2016, 5 pages. |
Written Opinion of the International Searching Authority dated Mar. 8, 2017, for PCT Application No. PCT/US2016/068452, filed on Dec. 22, 2016, 9 pages. |
U.S. Appl. No. 15/416,986, filed Jan. 26, 2017, by Satish et al. |
U.S. Appl. No. 15/594,017, filed May 12, 2017, by Satish et al. |
Extended European Search Report dated Jul. 12, 2019, for EP Application No. 19 156 549.8, filed on Jul. 9, 2012, 8 pages. |
Final Office Action dated Feb. 4, 2019, for U.S. Appl. No. 15/389,365, filed Dec. 22, 2016, 22 pages. |
Non-Final Office Action dated Feb. 21, 2019, for U.S. Appl. No. 15/594,017, filed May 12, 2017, 23 pages. |
“U.S. Appl. No. 13/544,664, Final Office Action dated Feb. 12, 2016”, 10 pgs. |
“U.S. Appl. No. 13/894,054, Final Office Action dated Aug. 26, 2016”, 7 pgs. |
“U.S. Appl. No. 14/876,628, Final Office Action dated Jul. 26, 2016”, 5 pgs. |
“U.S. Appl. No. 15/154,917, Decision on Appeal Brief mailed May 27, 2020”, U.S. Appl. No. 15/154,917, 2 pgs. |
“European Application Serial No. 12810640.8, Extended European Search Report, dated Apr. 1, 2015”, 8 pgs. |
“European Application Serial No. 13790449.6, Extended European Search Report dated Nov. 17, 2015”, 7 pgs. |
“European Application Serial No. 13790688.9, Extended European Search Report dated Nov. 23, 2015”, 9 pgs. |
“European Application Serial No. 16183350.4, Extended European Search Report, dated Nov. 4, 2016”, 8 pgs. |
“International Application Serial No. PCT/US2012/045969, International Search Report dated Sep. 17, 2012”, 2 pgs. |
“International Application Serial No. PCT/US2013/021075, International Search Report dated Mar. 26, 2013”, 2 pgs. |
“International Application Serial No. PCT/US2013/040976, International Search Report dated Sep. 24, 2013”, 2 pgs. |
“International Application Serial No. PCT/US2016/032561, International Preliminary Report on Patentability dated Nov. 30, 2017”, 7 pgs. |
“Optimizing protocols in obstetrics”, ACOG, Series 2, (2012), 25 pgs. |
“Quantification of blood loss: AWHONN practice brief number 1”, AWHONN Practice Brief, (2014), 1-3. |
Adkins, A R, et al., “Accuracy of blood loss estimations among anesthesia providers”, AANA Journal 82, (2014), 300-306. |
Aklilu, A, “Gauss Surgical Measures Blood Loss with a Smartphone”, [Online]. Retrieved from the Internet: <http://www.health2con.com/news/2012/06/14/gauss-surgical-measures-blood-loss-with-a-smartphone>, (Jun. 14, 2012). |
Al-Kadri, H M, et al., “Effect of education and clinical assessment on the accuracy of postpartum blood loss estimation”, BMC Preq. Childbirth 14, 110, 7 pgs. |
Bellad, et al., “Standardized Visual Estimation of Blood Loss during Vaginal Delivery with its Correlation Hematocrit Changes—A Descriptive Study”, South Asian Federation of Obstetrics and Gynecology 1.1, (2009), 29-34. |
Bose, P, et al., “Improving the accuracy of estimated blood loss at obstetric haemorrhage using clinical reconstructions”, BJOG 113(8), (2006), 919-924. |
Eipe, N, et al., “Perioperative blood loss assessment—How accurate?”, Indian J. Anaesth. 50(1), (2006), 35-38. |
Habak, P J, et al., “A comparison of visual estimate versus calculated estimate of blood loss at vaginal delivery”, British J. Med. Medical Res. 11(4), (2016), 1-7. |
Holmes, A A, et al., “Clinical evaluation of a novel system for monitoring surgical hemoglobin loss”, Anesth. Analg. 119, (2014), 588-594. |
Number | Date | Country | |
---|---|---|---|
20160331282 A1 | Nov 2016 | US |
Number | Date | Country | |
---|---|---|---|
62162117 | May 2015 | US |