This invention relates generally to the surgical field, and more specifically to a new and useful system and method for managing blood loss of a patient for use in surgical practice.
Overestimation and underestimation of patient blood loss is a significant contributor to high operating and surgical costs for hospitals, clinics and other medical facilities. Specifically, overestimation of patient blood loss results in wasted transfusion-grade blood and higher operating costs for medical institutions and can lead to blood shortages. Underestimation of patient blood loss is a key contributor of delayed resuscitation and transfusion in the event of hemorrhage and has been associated with billions of dollars in avoidable patient infections, re-hospitalizations, and lawsuits annually. Uninformed estimation of varying patient hematocrit during hemorrhage, blood transfusion, and intravenous saline infusion further exacerbates inaccurate estimation of patient red blood cell loss and negatively impacts the timing and quantity of fluids supplied to a patient intravenously. Thus, there is a need in the surgical field for a new and useful system and method for managing blood loss of a patient. This invention provides such a new and useful system and method.
The following description of preferred embodiments of the invention is not intended to limit the invention to these preferred embodiments, but rather to enable any person skilled in the art to make and use this invention.
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Hematocrit (HCT) (packed cell volume (PCV), erythrocyte volume fraction (EVF)) is the volume percentage of red blood cells in blood and is related to intravascular red blood cell count (RBC) and plasma volume (PV) according to the formula:
wherein the total volume of blood (VB) is the sum of RBC and PV. Hemoglobin is the primary, oxygen-transport metalloprotein in blood and makes up most (e.g., 98%) of the dry-weight of a red blood cell. Hematocrit is therefore a fundamental indicator of the oxygen-carrying capacity of blood and can be indicative patient fluid needs, such as intravenous infusion or transfusion of saline, blood, plasma, red blood cells in solution, etc.
Generally, first method S100 functions to estimate the intravascular hematocrit of a patient based on fluids lost by and fluids administered to the patient over time. First method S100 implements machine vision techniques to analyze images of physical samples, such as a surgical gauze sponge, a surgical towel, a surgical dressing, a surgical suction canister, a cell salvage canister, or a surgical drape, to estimate the quantity or volume of red blood cells (and therefore blood) lost by the patient. First method S100 also tracks intravenous administration of fluids, such as crystalloids (e.g., saline) or colloids (e.g., blood or blood components), over time, thereby maintaining a substantially current estimate of patient hematocrit based on fluids lost from and added to the patient's circulatory system over time. First method S100 can further account for other variables in estimating a current intravascular hematocrit of the patient, such as an initial known or estimated intravascular hematocrit, an estimated extracorporeal red blood cell mass or volume, an estimated extracorporeal hemoglobin mass or volume, and/or any intravenous fluid infusions or transfusions provided to the patient. Generally, by accounting for any of these variables over time, first method S100 can maintain a substantially reliable estimate of patient intravascular hematocrit.
During a medical event, blood loss reduces intravascular blood volume, and, to compensate, patients are often initially administered a saline drip or other intravenous non-blood (i.e., crystalloid) fluid to boost intravascular fluid volume. However, as the blood of the patient is diluted with saline or other non-blood-based fluid, the oxygen-carrying capacity of the patient's circulatory system diminishes, as indicated by reduced patient hematocrit. Patient risk increases with reduced blood volume and/or reduced red blood cell count per volume of blood, and first method S100 can therefore be useful in a hospital, medical clinic, or other medical facility or setting to track and maintain patient intravascular hematocrit. For example, first method S100 can be applicable in a surgical setting or during a childbirth in which a patient bleeds, wherein saline is administered to the patient to maintain intravascular (e.g., intravenous) volume and wherein a blood component (e.g., red blood cells) is subsequently administered to prevent excessive loss of intravascular oxygen-carrying capacity. First method S100 can therefore track the patient's intravascular fluid flux to maintain a current estimate of the patient's hematocrit, thereby enabling a user (e.g., a surgeon, anesthesiologist, nurse) to avoid over- and under-administration of fluids that could otherwise lead to hypovolemia, hypervolemia, and/or related complications.
First method S100 can additionally or alternatively function to estimate total blood, red blood cell, or hemoglobin loss of the patient over time, to detect the presence of blood in a sample (e.g., surgical gauze sponge, a surgical suction canister), to compute blood spread rate, to calculate blood surface area, to estimate patient risk level (e.g., hypovolemic shock), to determine patient hemorrhage classification, to provide warnings, to suggest administration of or automatically administer necessary fluids intravenously (e.g., blood, saline), or to provide any other functionality.
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Block S110 can monitor intravenous administration of fluid(s) by recording an initial time of administration of the fluid and tracking the quantity of the fluid administered to the patient according to a transfusion rate. In one example implementation, the computer system implementing first method S100 can include an interface through which a user can enter data related to a fluid infusion or transfusion. In this example implementation, the interface can guide the user to enter the type of fluid (e.g., saline, plasma, red blood cells, whole blood), a fluid flow rate (e.g., 100 mL/min of warmed blood), a transfusion or infusion start time, and/or an initial fluid volume in an IV bag, as shown in
In another example implementation, the computer system implementing first method S100 can include a flow sensor coupled to an IV line, wherein Block S110 monitors the volume of fluid administered to the patient based on an output of the flow sensor. For example, the flow sensor can be an optical flow sensor arranged over a metering block at the outlet of an IV bag. Therefore, in this example implementation, Block S110 can track one or more fluids administered to the patient substantially directly.
Block S110 can also receive data pertaining to the contents (i.e., composition) of infused or transfused fluid, such as through the interface of the computer system described above. Alternatively, Block S110 can implement machine vision to determine the contents of an IV bag, as described in U.S. Provisional Patent Application No. 61/722,780 and U.S. patent application Ser. No. 13/544,646.
In one example implementation, block S110 further interfaces with an optical sensor to capture an image of an IV bag, such as an allogeneic blood transfusion bag, a blood component (e.g., plasma, red blood cell) bag, or a saline therapy IV bag, and analyzes the image of the IV bag to estimate the composition of fluid therein. For example, Block S110 can receive a second image of the blood transfusion bag, extract a color-related feature from an area of the second image correlated with the blood transfusion bag, and estimate a red blood cell content of the blood transfusion bag based on the color-related feature. In this example. Block S110 can implement a parametric or non-parametric model to correlate the extracted (color) feature with a red blood cell concentration, as described in U.S. patent application Ser. No. 13/544,646 and U.S. patent application Ser. No. 13/738,919. Block S110 can further implement machine vision techniques, such as edge detection and/or template matching, to determine the type of IV bag, the level of fluid in the IV bag, and thus the volume of fluid in the IV bag. From this data, Block S110 can estimate the red blood cell count, plasma volume, and/or hematocrit of blood in the IV bag.
In the forgoing example implementation, Block S110 can further implement machine vision techniques to determine the type of bag in the image. For example, Block S110 can identify a bag with a rectangular perimeter as a blood transfusion bag and can identify a bag with a circular perimeter as a urethral catheter bag, wherein the blood transfusion bag is marked as containing fluid flowing into the patient and the urethral catheter bag is marked as containing fluid flowing out of the patient.
Alternatively, Block S110 can implement machine vision to scan a barcode, printed or embossed text, or handwritten text on the bag to identify the type and/or contents of the bag. In an example in which the bag is a blood transfusion bag, Block S110 can read a barcode on a sticker on the bag, access a database including the barcode, and retrieve bag type and/or content-related information from the database based on the barcode. In this example, first method S100 can thus also log entry of the blood transfusion bag into the operating room, check the blood type within the bag against the patient's blood type, capture an initial infusion time, and/or track blood inventory in an operating or delivery room.
Therefore, Block S110 can track intravenous administration of a crystalloid fluid, a colloid fluid, or any other suitable fluid. Block S110 can also receive the composition of an administered fluid, such as from a nurse or anesthesiologist, determine the composition of administered fluid directly by analyzing an image of the fluid, or determine the composition of administered fluid indirectly by accessing IV bag data, such as from a remote server or database. However, Block S110 can function in any other way to track a quantity of a fluid administered to the patient intravenously.
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As described in U.S. patent application Ser. No. 13,738,919, in one implementation in which the physical sample is a suction canister, a cell salvage canister, or other vessel. Block S122 can capture the image of the vessel according to a time schedule, such as every thirty seconds or every two minutes. Alternatively, Block S122 can implement machine vision and/or machine recognition techniques to identify the vessel within the field of view of the optical sensor and trigger image capture once a vessel is detected. For example, Block S122 can capture an image of the field of view of the optical sensor each time a user holds the camera (e.g., the computing device that incorporates the camera) up to the vessel. Similarly, Block S122 can capture the image of the physical sample once a threshold increase in the fluid volume of the vessel is detected. Therefore, Block S122 can capture images of the physical sample automatically, such as based on a timer, changes in fluid volume of the vessel, or availability of the vessel for imaging, which can enable first method S100 to track fluid collection in the vessel over time.
As described in U.S. patent application Ser. No. 13/544,646, in one implementation in which the physical sample is a surgical sponge gauze, Block S122 can implement machine vision and/or machine recognition techniques to identify the surgical sponge gauze in the field of view of the optical sensor and automatically capture the image of the surgical sponge gauze. Alternatively, in the foregoing implementations, Block S122 can capture the image of the physical sample according to a manual input, such as from a nurse or anesthesiologist.
Block S122 can also timestamp the image of the physical sample, such as based on when the image was captured, when the physical sample that is a surgical sponge gauze was used, and/or when the physical sample that is a fluid suction canister was filled, replaced, and/or emptied. Block S122 can thus enable first method S100 to track changes in both the patient's intravascular fluid volume and hematocrit based on a series of subsequent images, wherein an extracorporeal blood volume estimate for each image can be based on both an estimated red blood cell content of the physical sample in a particular image and a hematocrit estimated for a time approximately the same as that noted in the timestamp of the particular image. However, Block S122 can function in any other way to capture the image of the physical sample. Block S122 can also capture the second image of the second physical sample, as shown in
Block S130 of first method S100 recites extracting a feature from an area of the image correlated with the physical sample. Generally, Block S130 functions to identify and select a portion of the image that is indicative of the hemoglobin mass (or red blood cell content, red blood cell count, red blood cell volume, red blood cell mass, etc.) of the physical sample. In one example implementation, because red blood cells are red, Block S130 extracts the portion of the image by isolating a substantially red region of the image. In another example implementation, Block S130 implements object recognition to identity the physical sample in the image and to remove a background from the image. For example, Block S130 can implement object localization, segmentation (e.g., edge detection, background subtraction, grab-cut-based algorithms, etc.), gauging, clustering, pattern recognition, template matching, feature extraction, descriptor extraction (e.g., extraction of texton maps, color histograms, HOG, SIFT, etc.), feature dimensionality reduction (e.g., PCA, K-Means, linear discriminant analysis, etc.), feature selection, thresholding, positioning, color analysis, parametric regression, non-parametric regression, unsupervised or semi-supervised parametric or non-parametric regression, or any other type of machine learning and/or machine vision technique to select the representative area of the image. Block S130 can further identify the type of physical sample and/or estimate a physical dimension of the physical sample based on the selected area.
Block S130 can extract the feature, from one or more pixels of the image, that is a color (red), a color intensity (e.g., redness value), a luminosity, a hue, a saturation value, a brightness value, a gloss value, or other color-related value in one or more component spaces, such as the red, blue, green, cyan, magenta, yellow, key, and/or Lab component spaces. Block S130 can alternatively extract the feature that is a numerical color identifier, such as a HEX code value (e.g., #FF0000, #A00000, #880000, etc.) or an RGB code value (e.g., (255, 0, 0), (160, 0, 0), (190, 0, 0), etc.). Block S130 can also extract one or more features that is a histogram of various color or color-related values in a set of pixels within the image. As shown in
In one example implementation, Block S130 extracts a color intensity value of a set of pixels within an area of the image correlated with the physical sample such that Block S140 can estimate the red blood cell content of the physical sample by implementing a parametric model to transform the color intensity value into a quantity of red blood cells in the physical sample. In another example implementation, Block S130 extracts a subset of pixels from a set of pixels within an area of the image correlated with the physical sample such that Block S140 can estimate the red blood cell content of the physical sample by matching the subset of pixels with a template image in a library of template images of known red blood, cell content, as described in U.S. patent application Ser. No. 13/544,646.
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Therefore, Block S130 can extract from the image one or more features indicative of red blood cell content of the physical sample, such as described in U.S. patent application Ser. No. 13/544,646. However, Block S130 can function in any other way to extract a feature of any other suitable type or format from an area of the image correlated with the physical sample. Block S130 can also extract a feature of any suitable type or format from an area of the second image correlated with the second physical sample.
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In one implementation, Block S130 extracts features from pixel clusters in the image, and Block S140 tags each pixel cluster with a red blood cell content based on a non-parametric correlation of each pixel cluster with a template image in a library of template images of known red blood cell contents. For example, Block S130 can extract a color intensity in the red component space from a set of pixel clusters, and Block S140 can implement a K-nearest neighbor method to compare each extracted feature with redness intensity values of template images. In this example, each template image can include a pixel cluster tagged with a known fluid quality, such as hemoglobin or red blood cell volume or mass per pixel unit (e.g., hemoglobin or red blood concentration). Once a suitable match between a particular pixel cluster and a particular template image is found, Block S140 can project known red blood cell information from the particular template image onto the particular pixel cluster. Block S140 can then aggregate, average, and/or otherwise combine pixel cluster tags to output a total red blood cell content for the physical sample. However, Block S140 can correlate the extracted features with a red blood cell content via any other suitable non-parametric method or technique.
In the foregoing implementation, Block S130 can segment the portion of the image correlated with the physical sample, and Block S140 can match each segment with a template image to estimate the total red blood cell content of the physical sample. For example, Block S130 can segment the image statically according to predefined segment size and/or shape, such as a square ten-pixel by ten-pixel area. Alternatively, Block S130 can segment the image dynamically, such as according to redness, hue, saturation, shade, brightness, chroma, wavelength range, or any other metric or color of light in the image. Block S130 can also decompose each segment of the image (an ‘image segment’) into separate color components, such as a histogram of color intensity in the red, green, and blue color spaces, as shown in
In another implementation, Block S130 extracts features from pixel clusters from a portion of the image, and Block S140 implements a parametric model or function to tag each pixel cluster with a red blood cell content. As described in U.S. patent application Ser. No. 13/544,646, Block S140 can insert one or more extracted features from one pixel cluster into a parametric function to substantially directly transform the extracted feature(s) from the pixel cluster into a red blood cell content. Block S140 can then repeat this for each other pixel cluster in the area of the image correlated with the physical sample. For example, the extracted feature(s) can include any one or more of a color intensity in the red component space, a color intensity in the blue component space, and/or a color intensity in the green component space. In these examples, the parametric function can be a mathematical operation or algorithm that relates color intensity to hemoglobin mass per unit area of the related region of the physical sample. As described in U.S. patent application Ser. No. 13/544,646, reflectance of oxygenated hemoglobin (HbO2) at certain wavelengths of light can be indicative of the concentration of hemoglobin. Furthermore, because the hemoglobin content of a wet (hydrated) red blood cell is typically about 35%, red blood cell content can be extrapolated from the hemoglobin concentration based on a static estimated hemoglobin content (e.g., 35%). Therefore, in another example, Block S130 can extract a reflectance value at a particular wavelength of light for each pixel cluster in a set of pixel clusters in the image, and Block S140 can convert each reflectance value into a hemoglobin concentration value by implementing a parametric model. Block S140 can then combine the hemoglobin concentration values to estimate the total red blood cell content of the physical sample. Additionally or alternatively, Block S140 can implement a lookup table, a regression model, a non-negative least-squares algorithm, or any other suitable algorithm, method, or parametric model to transform one or more extracted features into a red blood cell content estimate for the physical sample.
However, Block S140 can implement any other parametric and/or non-parametric analysis of single pixels or pixel clusters within the image to estimate the red blood cell content of the physical image. Block S240 can implement the same or similar techniques to estimate the red blood cell content of the second physical sample. A time-based history of extracorporeal red blood cells can also be augmented with the output of Block S140 to maintain a current estimate of total patient red blood cell loss.
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In another implementation, Block S150 estimates a plasma volume of the physical sample based on the estimated red blood cell content of physical sample. For example, Block S150 can solve for PV in the equation
However, Block S150 can estimate the volume of any one or more blood components based on at least the red blood cell content estimate of the physical sample and/or according to any other formula or algorithm.
In one implementation, Block S150 implements a static hematocrit value to convert the red blood cell content to a blood or plasma volume. For example, the static hematocrit value can be a previous hematocrit value that was measured directly (i.e., with a centrifuge that separate components of a sample of the patient's blood), such as at the beginning of a surgery. In another example, the static hematocrit value can be a hematocrit value estimated based on a characteristic and/or demographic of the patient. In this example, Block S150 can interface with Block S180 described below to access a lookup table or algorithm relating patient age, gender, weight, and/or height to an average or predicted hematocrit value. The lookup table or algorithm can also account for a health condition of the patient that may affect the patient's hematocrit, such as anemia, leukemia, myeloma, or an eosinophilic disorder. The static hematocrit value can also be entered by a user, such as an anesthesiologist or a surgeon such as at the beginning or any other time during a surgery, delivery, etc.
In another implementation, Block S150 implements a dynamic hematocrit value to convert the red blood cell content to a blood or plasma volume. As described above, first method S100 can continuously and/or cyclically update the estimated hematocrit of the patient over time, such as in response to each subsequent image of a physical sample or every minute as additional fluid is administered to the patient intravenously. Therefore, in this implementation, Block S150 can access a previous hematocrit estimate (i.e., estimated in a previous application of Block S160) and apply the previous hematocrit estimate the red blood cell content estimate to generate an estimate of blood volume in the physical sample. For example, Block S150 can select a hematocrit estimate that was generated at approximately the same time that the image of the physical sample was captured. This example may be particularly applicable to the physical sample that is a surgical suction canister. In the implementation in which Block S122 tags the image with a time stamp based on when the physical sample was used, Block S150 can select the hematocrit estimate that was generated at approximately the same time that the physical sample was used. This example may be particularly applicable to the physical sample that is a surgical sponge gauze. Block S150 can additionally or alternatively select a most recent hematocrit estimate. However, Block S150 can select the dynamic hematocrit value according to any other schedule or schema. A time-based history of blood loss of the patient can also be augmented with the output of Block S150 to maintain a current estimate of total patient blood loss over time, as shown in
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As described in U.S. patent application Ser. No. 13/544,646, first method S100 can further access non-image features, such as weight of the physical sample, a direct measurement of a volume of fluid in the physical sample that is a canister, a clinician-estimated canister fluid volume, a fluid volumes and/or qualities of previous physical samples, previous fluid volumes and/or qualities of the physical sample that is a fluid canister, a sample counter, an ambient lighting condition, a type or other identifier of the physical sample, directly-measured properties of fluid in the physical sample, a patient vital sign, a patient medical history, altitude, an identity of a surgeon, a type of surgery or operation in process, or any other suitable non-image feature. For example, as described below and in U.S. patent application Ser. No. 13/544,646, Blocks of first method S100 can implement any of these non-image features to select template images for comparison with pixel clusters in the selected area, to select of a parametric model or function to transform the extracted feature(s) into a red blood cell count estimate, to define alarm triggers for excess fluid loss or hematocrit change, to transform one or more extracted features into a blood quantity indicator, or to transform one or more extracted features into a quantity or quality of another fluid or solid in the physical sample. However, first method S100 can implement any of these non-image features to modify, enable, or inform any other function or Block of first method S100.
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Generally, Block S160 functions to combine several variables related to, directly affecting, and/or indirectly affecting a quality and/or quantity of the patient's intravascular blood volume. Such variables can include fluid (e.g., blood plasma, saline) administered to the patient, blood lost by the patient, non-blood fluids lost or excreted by the patient, adsorption of fluid and electrolytes into or out of the circulatory system, etc., any of which can be dependent on time. Block S160 can also combine any one or more of the foregoing variables with constants also related to intravascular blood quantity and/or quality, such as an initial patient hematocrit (e.g., from Block S180), an initial blood volume (e.g., from Block S182), a composition of a colloid or crystalloid administered to the patient (e.g., from block S110), etc. Block S260 can similarly function to update the hematocrit estimate of the patient at a later time.
Block S160 and/or Block S260 can be repeated continuously or cyclically, such as throughout a surgery, delivery, or other medical event, to maintain a substantially current estimate of the hematocrit of the patient, as shown in
In one implementation, Block S160 (and Block S260) implements a first-order parametric model or algorithm to generate a substantially current estimate of intravascular patient hematocrit based on time-dependent and static variables. For example, hematocrit can be a function of: initial intravascular hematocrit HCTo, initial volume of blood, in the patient VBo; red blood cell (or hemoglobin) loss ΔRBCi; intravenous infusion of saline or other non-blood-based fluid ΔSi; intravenous transfusion of blood RB and the hematocrit of the transfused blood HCTB; time (ti−to), such as lag in adsorption of saline, previously infused into the patient, out of bloodstream tS,lag; etc.
In one example of this implementation, Block S160 can implement the following equations to estimate the intravascular hematocrit of the patient. First, the initial red blood cell count RBCo at initial time to can be estimated based on the initial intravascular hematocrit and blood volume of the patient according to the formulas:
From this, Block S160 can calculate the current intravascular hematocrit of the patient at a subsequent time ti according to the formula:
wherein ΔRBCi is the change in red blood cell (or hemoglobin) count over time and includes both blood transfusion and (estimated) blood loss from Blocks S140 and S150, and wherein ΔSi is intravenous infusion of saline or another non-blood-based fluid of known composition. ΔRBCi can be calculated according to the following formula:
ΔRBCi=−(Σn=1iRBCs,n)+RB×HCTB×(ti−tB,o)
wherein (Σn=1iRBCs,n) is the sum of estimated red blood cell volumes in all samples, which can be substantially correlated with the total estimated red blood cell loss of the patient. Furthermore, RB is the rate of blood transfusion, HCTB is the hematocrit of transfused blood, and RB·HCTB·(ti−tB,o)) is the total estimated red blood cell (or hemoglobin) count transfused into the blood steam of the patient between an initial transfusion time tB,o and the current time ti. Finally, ΔSi can be calculated according to the formula:
wherein RS is the volume flow rate of saline or other non-blood-based fluid administered to the patient intravenously, AS is an estimated absorbency rate of saline (or water) out of the bloodstream of the patient, and tS,lag is a lag in absorption of saline (or water) out of bloodstream. Block S260 can similarly estimate a subsequent hematocrit of the patient, such as at a later time t′. However, Block S160 and/or Block S260 can estimate the intravascular hematocrit of the patient according to any other model or algorithm.
In other implementations, Block S160 and Block S260 implement a second-, third-, fourth-, or other-order algorithm. Block S160 and Block S260 can also account for any other static or time-dependent variable related to intravascular and/or extracorporeal blood quantity and/or quality.
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Block S192 can additionally or alternatively provide suggestions related to patient care, such as to start or stop intravenous transfusion or infusion, to set a particular volume or volume flow rate of transfused or infused fluid, to respond to a hemorrhage, to delay a surgical operation until a patient condition reaches an acceptable status, to speed up a surgical operation before a patient condition reaches a certain status, or any other suitable suggestion. The warning and/or suggestion can also account for the age, weight, gender, health, or other demographic of the patient. Block S192 can further access an electrocardiogram (EKG) machine, an oximeter (e.g., a finger-type blood oxygen monitor), an IV drip monitor, or other monitor or sensor connected to the patient, or a medical record of the patient to further inform the warning or suggestion. For example, an oximeter connected to the patient that shows a substantially low oxygen level in the blood of the patient can verify a substantially low estimate of patient intravascular hematocrit. In another example, Block S192 accesses a medical record of the patient that indicates that the patient has chronic kidney disease, which necessitates a minimum viable intravascular hematocrit level greater than that of a similar patient without chronic kidney disease. However. Block S192 can function in any other way, access any other data, and provide any other turning or suggestion.
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Generally, second method S200 implements techniques described above to estimate a volume of patient blood loss over time through image processing of physical samples containing blood and to output a volemic status indicator that defines a metric of patient intracirculatory blood status. Second method S200 calculates the volemic status indicator based on a comparison between a measured patient hematocrit and an estimated euvolemic patient hematocrit (i.e., a quantitative difference between these values). The estimated euvolemic patient hematocrit can be based on a previous (measured or estimated) patient hematocrit, an estimated (initial or recent) patient blood volume, and an estimated patient blood loss, wherein the euvolemic patient hematocrit defines an estimated intracirculatory hematocrit of the patient if the estimated volume of patient blood loss is replaced perfectly with saline. The measured patient hematocrit can be a tested (e.g., actual) patient hematocrit value, such as measured with a non-invasive optical intracirculatory hematocrit monitor outputting measured hematocrit values on a regular time interval or measured by centrifuging a sample of the patient's blood. Patient hematocrit can also be stated in terms of the patient hemoglobin concentration (e.g., HGB (g/dL)), which is experimentally correlated with patient hematocrit according to a mean corpuscular volume (MCV) of the patient's erythrocytes. Second method S200 therefore generates the volemic status indicator that defines a magnitude of patient deviation from euvolemia. The volemic status indicator can define a composite of the effectiveness of intravenous fluid replenishment and insensible intracirculatory fluid losses (e.g., internal bleeding, sweating, evaporation from open incisions) of the patient.
Similar to first method S100 described above, second method S200 can therefore be useful to a surgeon, an anesthesiologist, a nurse, etc. in an operating room and/or during a surgery to manage fluid replacement and/or blood component therapy.
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Block S240 can also update a total estimated blood loss volume of the patient with the estimated blood volume in the physical sample. For example, Block S240 can maintain a running total of patient blood loss by adding the estimated volume of blood in each subsequent physical sample to a previous total. As shown in
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In one implementation, Block S250 subtracts the estimated blood volume in the physical sample from a previous estimated total intracirculatory blood volume of the patient to calculate a new total intracirculatory blood volume, converts the new total intracirculatory blood volume into an intracirculatory red blood cell volume (or mass) according to a previous patient hematocrit, and divides the intracirculatory red blood cell volume by the sum of the original total intracirculatory blood volume (i.e., the sum new total intracirculatory blood volume and the volume of saline replenishment) to estimate the euvolemic patient hematocrit. Alternatively, because hemoglobin mass and red blood cell volume are correlated, Block S250 can similarly convert the new total intracirculatory blood volume into an intracirculatory hemoglobin mass according to a previous patient hematocrit and divide the intracirculatory hemoglobin mass by the sum of the original total intracirculatory blood volume to estimate the euvolemic patient hematocrit. In this alternatively, Block S250 can output euvolemic patient hematocrit in the form of hemoglobin mass per (deci-) liter of blood (i.e., HGB g/dL).
Therefore, Block S250 can further receive a measured patient hematocrit from an optical intracirculatory hematocrit monitor coupled to the patient (e.g., arranged on a patient's finger). Block S250 can alternatively receive the measured patient hematocrit from an electronic medical record (e.g., laboratory-run hematocrit), or from a bedside spot-check device (e.g. an intraoperative assay of hematocrit), and Block S250 can receive the measured patient hematocrit continuously, or semi-continuously, on a constant or varying interval, or according to any other schedule.
Alternatively, Block S250 can implement a previously-estimated patient hematocrit or estimate an initial patient hematocrit according to a weight of the patient, a height of the patient, a gender of the patient, an age of the patient, and/or a health status of the patient, etc. Block S250 can similarly estimate the total patient intracirculatory blood volume according to the weight of the patient, the height of the patient, the gender of the patient, the age of the patient, and/or the health status of the patient, etc. Block S250 can alternatively receive an estimated total patient intracirculatory blood volume, such as from an anesthesiologist through a touch display following a user tracer-based intracirculatory blood volume test, or implement an intracirculatory patient hematocrit from a previous timestep. However, Block S250 can function in any other way to estimate a euvolemic patient hematocrit.
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Generally, Block S282 can extrapolate a measure of regulation and/or loss of fluid out of the patient's intravascular space, including a comparison of total blood volume and peripheral venous blood volume, and a measured hematocrit received in Block S260 (i.e., a peripheral venous hematocrit) can indicate red blood cell concentration in the patient's vascular system. As part of a body's natural fluid regulation, a patient's body may experience hemoconcentration and/or hemodilution between the vascular system and interstitial spaces. For example, during heaving lifting or a work out, a muscle may “pump” as the body sends blood into peripheral spaces to aid a muscle recovery, which engorges the muscle, and hematocrit in the region of the muscle may therefore shift due to internal fluid replacement. Similarly, during acute hemorrhage, a body may replace fluid internally and local to the hemorrhage, and Block S250 can output the volemic status indicator that incorporates a body's fluid dynamics into one metric that is deviation from euvolemia. By comparing the estimated intracirculatory patient hematocrit and the measured patient hematocrit, Block S282 can thus output a quantitative measure of a patient's body dynamics.
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The system 100 functions to implement first method S100 described above, wherein the optical sensor (e.g., camera) implements Block S122 to capture the image of the canister and the processor 120 implements Blocks S110, S120, S130, S140, S150, S160, S220, S240, S260, etc. described above according to the software module 122 to continuously and/or cyclically estimate a current intravascular hematocrit of the patient. A surgeon, nurse, anesthesiologist, gynecologist, doctor, soldier, or other user can implement the system 100 to track the intravascular hematocrit of the patient over time, such as during a surgery, childbirth, or other medical event. The system 100 can also detect presence of blood in the physical sample(s), compute patient blood loss rate, estimate patient risk level (e.g., hypovolemic shock), determine hemorrhage classification of a patient. However, the system 100 can perform any other suitable function.
As shown in
The system 100 can be used in a variety of settings, including in a hospital setting, such as in a surgical operating room, in a clinical setting, such as in a delivery room, in a military setting, such as on a battlefield, or in a residential setting, such as to aid a consumer in monitoring blood quality and quantity during menorrhagia (heavy menstrual bleeding) or epistaxis (nosebleeds). However, the system 100 can be applicable to any other setting.
The interface 102 of the system 100 functions to receive data related to intravenous administration of a fluid to the patient. Generally, the interface 102 defines an input region through which a user can enter infusion and/or transfusion details. For example, a nurse, surgeon, or anesthesiologist can enter, through the interface 102, the type, total volume, flow rate, and start time of a crystalloid or colloid fluid administered to the patient intravenously, as shown in
The interface 102 can be any suitable type of interface. In one example, the interface 102 is a keyboard connected to a local computer (e.g., desktop or laptop computer) containing the processor 120, the optical sensor 110, and the display 130. Alternatively, the interlace 102 can be a sensor component of a touchscreen integrated into a mobile electronic device (e.g., a smartphone, a tablet), wherein the electronic device includes the optical sensor 110 and the processor 120, and wherein the output portion of the touchscreen defines the display 130. The interface 102 can alternatively interface with an IV drip sensor to estimate the flow rate of fluid administered to the patient, and the interface can further receive an image of an IV bag and analyze the image to estimate the volume and/or contents of the IV bag, as described above. However, the interface 102 can function in any other way to receive manual or automatic entry of data pertaining to fluid administered to the patient intravenously. The interface 102 can further receive data pertaining to administration of multiple different fluids simultaneously or in series, such as a simultaneous administration of saline and red blood cells or consecutive administration of saline and then blood.
The optical sensor 110 of the system 100 functions to capture the image of the physical sample. Generally, the optical sensor 110 can implement Block S122 of first method S100 described above, as controlled by the software module 122. In one example implementation, the optical sensor 110 is a digital camera that captures a color image of the physical sample or an RGB camera that captures independent image components in the red, green, and blue component spaces. However, the optical sensor 110 can be any number and/or type of cameras, charge-coupled device (CCD) sensors, complimentary metal-oxide-semiconductor (CMOS) active pixel sensors, or optical sensors of any other type. However, the optical sensor 110 can function in any other way to capture the image of the physical sample, such as in any suitable form or across any suitable visible or invisible spectra.
In one implementation the optical sensor 110 is a camera arranged within a handheld electronic device. In another implementation, the optical sensor 110 is a camera or other sensor configured to be mounted on a pedestal for placement in an operating room, configured to mount to a ceiling over an operating table, configured for attachment to a battlefield helmet of a field nurse, configured to mount to a standalone hematocrit estimation system including the interface 102, the processor 120, the display 130, and a staging tray that supports the physical sample for imaging, or configured for placement in or attachment to any other object or structure.
According to instructions from the software module 122, the processor 120 of the system 100 tracks a quantity of the fluid administered to the patient according to data received by the interface 102, estimates a red blood cell content of the physical sample based on a feature extracted from the image, and estimates a hematocrit of the patient based on a previous hematocrit of the patient, the fluid administered to the patient, and the estimated red blood cell content of the physical sample. Generally, the processor 120 implements one or more Blocks of first method S100 described above according to instructions from the software module 122. The processor 120 can further repeat execution of these instructions in response to additional images of additional physical samples over time to generate a trendline of estimated patient hematocrit over time. The processor can therefore receive and analyze images of any one or more suitable types (e.g., static, streaming, .MPEG, .JPG, .TIFF) and/or images from one or more distinct cameras or optical sensors.
The processor 120 can be coupled to the optical sensor 110, such as via a wired connection (e.g., a trace on a shared PCB) or a wireless connection (e.g., a Wi-Fi or Bluetooth connection), such that the processor 120 can access the image of the physical sample captured by the optical sensor 110 or visible in the field of view of the optical sensor 110. In one implementation, the processor 120 is arranged within a handheld electronic device that also contains the optical sensor 110 and the display 130. In another implementation, the processor 120 is a portion of or is coupled to a remote server, wherein image data from the optical sensor 110 is transmitted (e.g., via an Internet or local network connection) to the processor 120 that is remote, wherein the processor 120 estimates the extracorporeal red blood cell content and/or blood volume in the physical sample and estimates the hematocrit of the patient based on the estimated red blood cell content and/or blood volume, and wherein the hematocrit estimate is transmitted to the display 130.
In one implementation and as described above, the processor 120 can estimate the red blood cell content in the physical sample by matching a portion of the image of the physical sample to a template image, wherein the template image is one template image in a library of template images. For example, the system 100 can further include a data storage module 160 configured to store a library of template images of known contents and/or concentrations of the red blood cells. In this implementation, the processor can correlate the extracted features with the red blood, cell count by comparing a feature extracted from the image with a template image in the library of template images, as described above. Alternatively and as described above, the processor 120 can implement a parametric model to estimate the red blood cell content in the physical sample based on the feature extracted from the image.
The processor 120 is further coupled to the interface 102 to receive data pertaining to administration of fluid to the patient over time. For example, the processor 120 can receive, from the interface 102, the type, total volume, flow rate, and start time of administration of a fluid into the patient. From this initial data, the processor 120 can integrate the flow rate over time, in light of the composition of the administered fluid and the total volume of the IV bag, to determine the total volume, parts, mass, weight, etc. of fluid, blood cells, electrolytes, etc. delivered to the patient up to any given time.
The processor 120 further implements Block S160 described above to aggregate multiple variables related to, directly affecting, and/or indirectly affecting a quality and/or quantity of the patient's intravascular blood volume. As described above, such variables can include fluid (e.g., blood plasma, saline) administered to the patient, blood lost by the patient, non-blood fluids lost or excreted by the patient, adsorption of fluid and electrolytes into or out of the circulatory system, etc., any of which can be dependent on time, as well as initial patient hematocrit, an initial blood volume, a composition of a colloid or crystalloid administered to the patient, etc. The processor can therefore continuously and/or cyclically estimate the hematocrit of the patient over time in light of further blood loss (e.g., as determined through analysis of images of additional physical samples) and further intravenous administration of fluids (e.g., based on data collected by the interface 102).
The software module 122 of the system 100 functions to control the interface 102, the optical sensor 110, the processor 120, and the display 130 to receive patient IV data, capture the image of the physical sample, analyze the image, and estimate the hematocrit of the patient. The software module 122 can execute on the processor 120 as an applet, a native application, firmware, software, or any other suitable form of code to control processes of the system 100. Generally, the software module controls implementation of Blocks of first method S100 described above within the system 100, though the software module 122 can control and/or implement any other suitable process or method on or within the system 100.
In one example application, the software module 122 is a native application installed on the system 100 that is a handheld (i.e., mobile) computing device, such as a smartphone or tablet. When selected from a menu within an operating system executing on the computing device, the software module 122 opens, interfaces with a user to initialize a new case, receives IV data through the interface 102 that includes a touchscreen, controls the optical sensor 110 integrated into the computing device to capture the image of the physical sample, implements machine vision and executes mathematical algorithms on the processor 120 to estimate the quantity of red blood cells in the physical sample and the hematocrit of the patient, and controls the display 130 to render the estimated current hematocrit of the patient, as shown in
The display 130 of the system 100 renders the estimated hematocrit of the patient. The display 130 can be arranged within the handheld electronic device (e.g., smartphone, tablet, personal data assistant) that also contains the optical sensor 110 and the processor 120. The display 130 can also be physically coextensive with the interface, such as in one implementation of the system 100 that is a handheld electronic device including a touchscreen. Alternatively, the display can be a computer monitor, a television screen, or any other suitable display physically coextensive with any other device. The display 130 can be any of an LED, OLED, plasma, dot matrix, segment, e-ink, or retina display, a series of idiot lights corresponding to estimated hematocrit ranges, or any other suitable type of display. The display 130 can further be in communication with the processor 120 via any of a wired and a wireless connection.
The display 130 can also render an estimated quantity of the blood and/or red blood cell content of one or more physical samples, a current total estimated red blood cell loss or blood loss of the patient, a current estimated intravascular blood volume or percentage blood volume of the patient, a hemorrhage rating or risk of the patient, or any other suitable blood-related variable or parameter of the patient. As described in U.S. patent application Ser. No. 13/738,919, this data can be presented in the form of a dynamic augmented reality overlay on top of a live video stream of an operating room and/or an imaging area for physical samples. For example, images from the optical sensor 110 can be relayed substantially in real time, through the processor 120, to the display 130 wherein the images are rendered concurrently with a current estimated hematocrit of the patient, an estimated blood volume of a recent physical sample, and a total estimated patient blood loss. The display 130 can also render any of the foregoing or other data in table, chart, or graphical form, such as multiple time-dependent hematocrit estimates. The display 130 can also render any of an image of a previous physical sample, a patient risk level (e.g., risk of hypovolemic shock), a hemorrhage classification of the patient, and/or a warning or suggestion, such as to begin a blood transfusion. Any of these data, warnings, and/or suggestions can also be depicted across multiple screens or menus or made accessible through the display 130 and/or interface 102 in any other suitable way.
As shown in
In one example implementation, the software module 122 triggers the alarm module 170 in response to an estimated patent hematocrit that falls outside a predefined range of safe hematocrit values, which can be based on the age, gender, health status, demographic, etc. of the patient. For example, the predefined range of safe hematocrit values for a male patient between the ages of 20 and 60 can be 0.39 to 0.50, whereas the predefined range of safe hematocrit values for a female patient between the ages of 20 and 60 can be 0.36 to 0.44. In another example implementation, the software module 122 triggers the alarm module 170 in response to an estimated total patient red blood cell loss that falls outside a predefined maximum percentage of loss of the estimated total initial red blood cell count of the patient. For example, the software module 122 can trigger the alarm module when the patient has lost more than 20% of his initial red blood cell count. In yet another example implementation, the software module 122 triggers the alarm module 170 in response to an estimated increase in intravascular fluid volume of patient that exceeds a threshold increase over the initial patient blood volume, such as a 10% increase over the initial patient blood volume. However, the software module 122 can trigger the alarm module 170 in response to any other blood-related value.
As shown in
As shown in
The systems and methods of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions are executed by computer-executable components integrated with the system 100, the optical sensor, the processor, the display, hardware/firmware/software elements of a system or handheld computing device, or any suitable combination thereof. Other systems and methods of the embodiments can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions are executed by computer-executable components integrated by computer-executable components integrated with apparatuses and networks of the type described above. The computer-readable medium can be stored on any suitable computer readable media such as RAMS, ROMS, flash memory, EEPROMs, optical devices (CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable component is a processor but any suitable dedicated hardware device can (alternatively or additionally) execute the instructions.
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 preferred embodiments of the invention without departing from the scope of this invention defined in the following claims.
This application is a divisional of U.S. patent application Ser. No. 13/894,054, filed on 14 May, 2013, now issued as U.S. Pat. No. 9,936,906, which also claims the benefit of U.S. Provisional Patent Application No. 61/776,577, filed on 11 Mar. 2013, U.S. Provisional Patent Application No. 61/646,822, filed on 14 May 2012, and U.S. Provisional Patent Application No. 61/722,780, filed on 5 Nov. 2012, all of which are incorporated herein in their entireties by this reference. This application is related to U.S. patent application Ser. No. 13/544,646, filed on 9 Jul. 2012, and to U.S. patent application Ser. No. 13/738,919, filed on 10 Jan. 2013, both of which are incorporated herein in their entireties by this reference.
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Number | Date | Country | |
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20190008427 A1 | Jan 2019 | US |
Number | Date | Country | |
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61776577 | Mar 2013 | US | |
61722780 | Nov 2012 | US | |
61646822 | May 2012 | US |
Number | Date | Country | |
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Parent | 13894054 | May 2013 | US |
Child | 15943561 | US |