Providing guidance in medical procedures

Abstract

The disclosure relates to providing guidance in medical procedures. Described herein are example methods and example systems for providing guidance to a user during a medical procedure. An example method may be executed by one or more processors and may include estimating a blood loss volume of a patient, determining a current patient phase of a blood loss protocol based on the estimated blood loss volume of the patient, and providing guidance to a user based on the current patient phase of the blood loss protocol. The blood loss protocol may include multiple stages, and each stage may include one or more elements. Providing guidance to a user may include selecting one or more elements from a current patient stage of a blood loss protocol.

Description

[0001] This application is a divisional application of the invention patent application with the title "Providing Guidance in Medical Procedures" of PCT application PCT / US2020 / 040248 with Chinese application number 202080052757.9 and filing date June 30, 2020. Technical Field

[0002] The subject matter disclosed herein generally relates to the field of healthcare technology, and more particularly to new and useful systems and methods for providing guidance during medical procedures. Such systems include dedicated machines that facilitate providing guidance during medical procedures, computerized variants of such dedicated machines configured with software, and improvements to such variants, as well as improvements to techniques that improve such dedicated machines compared to other dedicated machines that facilitate providing guidance in medical procedures. Background Art

[0003] Effectively managing and responding to patient blood loss during a medical procedure helps avoid complications. However, effectively managing and responding to patient blood loss involves various challenges, such as inaccurate reporting of patient blood loss and misuse of best practice protocols for blood loss management. For example, doctors and other medical staff often visually estimate a patient's blood loss. This results in significant errors, which can lead to a misrepresentation of the severity of the patient's bleeding risk and the failure of steps to effectively manage the patient's blood loss and prevent resulting complications. For example, underestimating a patient's blood loss can lead to delays in resuscitation and blood transfusion, increased risk of infection, tissue death, or even patient death, such as in a bleeding event. Therefore, providing new and improved systems and methods for providing guidance during medical procedures to improve patient outcomes can be beneficial. Brief Description of the Drawings

[0004] Figure 1 is a schematic block diagram depicting a method for guiding a user (e.g., a doctor, such as a surgeon, or other medical staff) during a medical procedure according to some example embodiments.

[0005] Figure 2 is a schematic depiction of a blood loss protocol according to some example embodiments.

[0006] Figure 3 is a schematic block diagram depicting a method for estimating the amount of blood components within a substrate according to some example embodiments.

[0007] Figure 4 is a schematic depiction of a blood loss protocol and a method for selecting elements from the blood loss protocol to provide guidance to a user according to some example embodiments.

[0008] Figure 5is a schematic block diagram depicting a method for guiding a user during a medical procedure according to some example embodiments.

[0009] Figure 6 is a depiction of a graphical user interface (GUI) according to some example embodiments, which includes elements for guiding a user's blood loss protocol.

[0010] Figure 7 is a depiction of a GUI according to some example embodiments, the GUI including elements from multiple patient stages of a blood loss protocol to guide a user.

[0011] Figure 8 is a depiction of a summary graphic that can be displayed to a user (e.g., via a GUI) during a medical procedure according to some example embodiments.

[0012] Figure 9 is a schematic depiction of a data record for storing and organizing data generated during a medical procedure according to some example embodiments.

[0013] Figure 10 is a schematic depiction of a system for guiding a user during a medical procedure according to some example embodiments.

[0014] Figure 11 is a schematic depiction of a blood loss protocol according to some example embodiments.

[0015] Figure 12 is a depiction of a GUI including elements of a blood loss protocol to guide a user according to some example embodiments.

[0016] Figure 13 is a depiction of a GUI including a summary graphic that can be displayed to a user during a medical procedure according to some example embodiments.

[0017] Figure 14 is a depiction of a GUI that allows a user to manually input the volume of fluid measured using a fluid container according to some example embodiments.

[0018] Figure 15 is a schematic block diagram depicting a method for guiding a user during a medical procedure according to some example embodiments. Detailed Description

[0019] Example methods (e.g., algorithms) facilitate providing guidance during a medical procedure (e.g., during a surgical procedure), and example systems (e.g., dedicated machines configured by dedicated software) are configured to facilitate providing guidance during a medical procedure. The examples are merely representative of possible variations. Unless otherwise explicitly stated, structures (e.g., structural components such as modules) are optionally combinable or subdividable, and operations (e.g., in a process, algorithm, or other function) can vary in order or be combined or subdivided. In the following description, numerous specific details are set forth for purposes of explanation to provide a thorough understanding of various example embodiments. However, it will be apparent to those skilled in the art that the subject matter may be practiced without these specific details.

[0020] Any one or more of the example methods and systems discussed herein can be used to provide guidance (e.g., to one or more users such as one or more doctors or other medical staff) during a medical procedure (e.g., a surgical procedure performed on a patient). One or more of the example methods can utilize one or more processors to perform operations (e.g., steps) specified for providing guidance during a medical procedure. Generally, the example methods discussed herein can include estimating a patient's blood loss (e.g., estimating the amount of blood the patient has lost), determining a current patient stage of a blood loss protocol based on the estimated blood loss (e.g., determining the current stage of the patient within the protocol for addressing blood loss), and providing guidance to a user (e.g., a doctor) based on the current patient stage of the blood loss protocol. Any suitable blood loss protocol can be used to guide a user during a medical procedure. In some example embodiments, the blood loss protocol can be or include a predetermined protocol for managing the bleeding risk (e.g., for a patient undergoing a medical procedure, for a general patient, or both). The blood loss protocol (e.g., for managing the bleeding risk) can include multiple patient stages, which can be described based on the severity of the patient's blood loss. The blood loss protocol can be stored in one or more memory devices. In some example embodiments, the blood loss protocol can be accessed by one or more processors to provide guidance to a user. Additionally, the blood loss protocol can be customized based on one or more user settings. For example, such user settings can include one or more threshold blood loss values associated with each of the multiple patient stages of the blood loss protocol. Each of the multiple patient stages of the blood loss protocol can be associated with a corresponding lower blood loss threshold and a corresponding upper blood loss threshold (e.g., to define a range of blood loss amounts). Thus, the determination of the current patient stage can include comparing the estimated blood loss with the thresholds associated with one or more patient stages of the blood loss protocol.

[0021] In some example embodiments, the estimation of the patient's blood loss includes estimating the amount of blood in a fluid-containing substrate, such as a fluid container or a surgical article (such as a fabric). Estimating the amount of fluid in the substrate may include using one or more image analysis techniques. For example, the estimation of the patient's blood loss may include evaluating color parameters in one or more images depicting the fluid-containing substrate. In some example embodiments, the estimation of the patient's blood loss includes correlating the color parameters with the concentration of blood components in the fluid-containing substrate to estimate the amount of blood contained in the substrate. For example, the estimation of the patient's blood loss may include comparing the color parameters of at least a portion of the image with a template image to determine the concentration of blood components associated with at least a portion of the fluid-containing substrate. As another example, the estimation of the amount of blood contained in the fluid-containing substrate may include using parametric equations to determine the blood component concentration based on the color parameters. In some example embodiments, the estimation of the patient's blood loss includes combining the amounts of blood in multiple fluid-containing substrates. In some example embodiments, determining the patient's blood loss includes detecting or determining the weight of the fluid-containing substrate. The weight information may be used instead of or in combination with the information obtained from analyzing images depicting the fluid-containing substrate. For example, one or more image analysis techniques may be used to determine the blood component concentration, and the weight information may be used to determine the volume of fluid in the fluid-containing substrate. The concentration and volume may be used to determine the patient's blood loss.

[0022] In some example embodiments of the methods and systems for providing guidance to a user during a medical procedure described herein, an estimated patient blood loss is used to inform the guidance provided to the user, and the guidance may be based on a blood loss protocol. The blood loss protocol for providing guidance to the user may include multiple patient phases. Each patient phase may include one or more elements. One or more of the elements in any given phase may be or include a recommended action (e.g., start a blood transfusion, administer an intravenous (IV) infusion, provide a particular drug to the patient, or any suitable combination thereof). Thus, in some example embodiments, providing the guidance includes selecting one or more elements from the current patient phase of the blood loss protocol. The selection, generation, provision of guidance, or any suitable combination thereof may be based on the estimated patient blood loss (e.g., by selecting elements from the current patient phase, which may be determined based on the estimated patient blood loss). However, in some example embodiments, the guidance may also be based on user input (e.g., one or more user inputs from one or more users). For example, user input (e.g., an indication of an action the user has taken, or patient information manually entered by the user) may affect one or more of the elements selected by the processor to provide guidance to the user. Providing guidance to the user may also involve displaying on a display (e.g., the display screen of a mobile computing device such as a laptop computer, a tablet, or a smart phone) one or more elements selected from the current patient phase of the protocol or a previous or subsequent patient phase. Additionally or alternatively, the guidance may be provided in the form of or in combination with other visual notifications (e.g., a light such as an LED on the device), audio notifications (e.g., through one or more speakers), tactile notifications (e.g., vibration, etc.), or any suitable combination thereof.

[0023] In some example embodiments of the methods and systems described herein, guiding a user through a blood loss protocol includes providing updated guidance (e.g., based on an updated estimate of the patient's blood loss). The guidance to be provided can be updated in any suitable manner. For example, providing guidance can include estimating the updated patient blood loss (e.g., updating the estimated blood loss of the patient), and determining an updated patient stage based on the updated estimated patient blood loss. Thus, the updated guidance can be provided based on the updated patient stage. In some example embodiments, the updated guidance can be provided based on one or more user inputs. For example, the updated guidance can be provided based on an indication that the user has performed one or more elements of the blood loss protocol. In some example embodiments, the updated guidance can be based on both user input and the updated patient stage of the blood loss protocol. Providing the updated guidance can include displaying the updated guidance, such as on a display screen (e.g., a display screen of a mobile computing device such as a laptop computer, a tablet computer, a smart phone, or any suitable combination thereof). In some example embodiments, providing guidance includes providing a notification associated with the current patient stage of the blood loss protocol. The guidance can be provided as a visual notification (e.g., on a display, one or more lights, or any suitable combination thereof), an audio notification (e.g., one or more audio alerts via one or more speakers), a tactile notification (e.g., one or more vibrations). For example, it may be desirable to notify the user periodically or intermittently of the current patient stage, when the current patient stage changes, or both.

[0024] This document also describes example systems for providing guidance to a user during a medical procedure. Generally speaking, the example systems discussed herein include one or more processors configured to estimate a patient's blood loss, determine a current patient stage of a blood loss protocol based on the estimated blood loss, and provide guidance to the user based on the current patient stage of the blood loss protocol. The blood loss protocol can include multiple patient stages, and each patient stage can include one or more elements. For example, the elements of a patient stage can be or include recommending one or more user actions. Providing guidance to the user can include selecting (e.g., via a processor) one or more elements from the current patient stage of the blood loss protocol. Thus, one or more processors of one or more systems for providing guidance to the user can be configured to select one or more elements from the current patient stage of the blood loss protocol. Additionally, one or more processors can be configured to provide updated guidance to the user based on user input, an updated patient stage of the blood loss protocol, or both. In some example embodiments, one or more processors are configured to estimate an updated blood loss of the patient, and one or more processors can determine an updated patient stage based on the updated patient blood loss. The example systems discussed herein can include a display configured to display information provided to the user, such as guidance (e.g., one or more elements from the current patient stage of the blood loss protocol).

[0025] Furthermore, in some example embodiments, the example methods discussed herein include estimating a medical parameter of a patient, determining a current patient stage of a medical parameter protocol based on the estimated medical parameter, and providing guidance to the user based on the current patient stage of the medical parameter protocol. Any suitable medical parameter protocol can be used to guide the user during a medical procedure. Similarly, in some example embodiments, the example systems discussed herein include one or more processors configured to estimate a medical parameter of a patient, determine a current patient stage of a medical parameter protocol based on the estimated medical parameter, and provide guidance to the user based on the current patient stage of the medical parameter protocol. Examples of such medical parameters include blood loss, blood pressure, hematocrit, hemoglobin concentration, concentration of another blood component, heart rate, coagulation (e.g., characterized by thromboelastogram (TEG)), temperature, oxygen saturation, height, weight, age, body mass index (BMI), gender, body fat percentage, intravenous infusion, or any suitable combination thereof. One or more of the example methods described herein (e.g., estimated blood loss or estimated blood component concentration), using suitable instruments (e.g., sphygmomanometer, scale, pulse oximeter, thermometer, flow meter coupled to an IV set, etc.), or any suitable combination thereof can be used to estimate one or more of such medical parameters.

[0026] Any one or more of the example methods and systems discussed herein can be used to provide guidance to one or more users (e.g., one or more doctors or other medical personnel) during a medical procedure (e.g., performed on a patient). Such methods and systems can utilize one or more processors to perform various operations (e.g., steps), such as estimating a patient's blood loss, determining the current patient stage of a blood loss protocol, and providing guidance to the user based on one or more of the current patient stage (e.g., further based on one or more user inputs).

[0027] Overview of Example Methods

[0028] One or more of the example methods described herein can be used to provide guidance to one or more users during a medical procedure. The provision of such guidance can include using one or more processors to perform one or more method operations (e.g., method steps). Generally, such methods can include estimating a patient's blood loss and using the estimated blood loss to inform (e.g., generate, select, or otherwise determine) the guidance to be provided to the user. In some example embodiments, such as in the example embodiments depicted in Figure 1 In the example embodiment depicted in, method 100 for providing guidance to a user includes estimating 110 the patient's blood loss, determining 120 the current patient stage of a blood loss protocol based on the estimated blood loss, and providing 130 guidance to the user at least in part based on the current patient stage.

[0029] A blood loss protocol (e.g., selected from various available blood loss protocols) can include multiple patient stages, which can be based on the severity of the patient's blood loss, and each patient stage can include one or more elements of that patient stage. In some example embodiments, one or more of the elements of a patient stage can include one or more recommended actions to be performed by the user to manage the patient's blood loss. In some example embodiments, the estimated patient blood loss can be used to determine the current patient stage of the blood loss protocol. Thus, the methods discussed herein can include estimating a patient's blood loss. In some example embodiments, the determination of the current patient stage involves comparing the estimated patient blood loss with one or more blood loss value ranges. Each range can be associated with a different patient stage of the blood loss protocol. Thus, the estimated patient blood loss can be related or otherwise associated with a particular patient stage of the blood loss protocol, and this correlation can be used as a basis for determining the current patient stage of the blood loss protocol (e.g., by comparing the estimated patient blood loss with the blood loss value range of that patient stage among the various blood loss value ranges associated with the blood loss protocol).

[0030] In some example embodiments, one or more of a plurality of estimated medical parameters (e.g., individually or in combination) can be used to determine a current patient stage in a blood loss protocol. Examples of such medical parameters include blood loss volume, blood pressure, hematocrit, hemoglobin concentration, concentration of another blood component, heart rate, coagulation (e.g., characterized by TEG), temperature, oxygen saturation, height, weight, age, BMI, gender, body fat percentage, intravenous infusion, or any suitable combination thereof. One or more of the methods described herein (e.g., estimated blood loss volume or estimated blood component concentration), a suitable instrument (e.g., sphygmomanometer, scale, pulse oximeter, thermometer, flow meter coupled to an IV set, etc.), or any suitable combination thereof can be used to estimate one or more of such medical parameters. As an illustrative example, if a patient has a high heart rate (e.g., greater than 120 bpm) and high systolic blood pressure (e.g., greater than 160 mmHg) at a given age (e.g., greater than 70 years), a suitable method can include determining the current patient stage of the patient based on the combination of these medical parameters. For example, the current patient stage can be determined by comparing each medical parameter with a range of medical parameter values associated with respective patient stages of the blood loss protocol.

[0031] In some example embodiments, providing guidance during a medical procedure includes selecting one or more elements from a patient stage of a blood loss protocol (e.g., the current patient stage). For example, providing guidance can involve selecting one or more elements from the current patient stage of the blood loss protocol. The providing of guidance can include displaying the guidance (e.g., including the one or more selected elements) to a user via a display screen (e.g., displaying the one or more elements on a display screen of a mobile computing device or presenting them in some other manner), providing one or more of any suitable notifications (e.g., other notifications such as other visual notifications, audio notifications, tactile notifications, etc.), or any suitable combination thereof.

[0032] The guidance provided to a user can be based on the current patient stage of the blood loss protocol, user input, or both (e.g., generated, selected, retrieved, or otherwise determined based thereon). In some example embodiments, guidance can be provided based on the current patient stage of the blood loss protocol (e.g., where the current patient stage determines one or more elements that a processor is to select to include in the guidance to be provided). Guidance can be provided based on the blood loss stage and user input. For example, a user can indicate that the user has performed a particular action, which can inform the guidance to be provided to the user. In some example embodiments, the methods for guiding a user discussed herein include providing updated guidance. For example, the guidance can be updated based on user input, an updated current patient stage (e.g., based on an updated blood loss estimate), or both. Providing guidance can include displaying the guidance, the updated guidance, or both on a display screen (such as on a display screen of a mobile computing device).

[0033] Example blood loss protocol

[0034] One or more of the example methods described herein may include using a blood loss protocol. For example, a bleeding protocol may provide a set of predefined steps that are developed based on best practices that have demonstrated desired outcomes in medical procedures. A bleeding protocol may classify the severity of the bleeding risk into stages (e.g., patient stages) based on the amount of blood lost by the patient. Each stage may provide steps for a user to efficiently manage the patient's blood loss risk. One or more of the individual steps in the blood loss protocol may be provided to the user to guide the user through a series of one or more actions to manage the patient's blood loss. According to any one or more of the methods described herein, while a bleeding protocol may be employed in an operating room (e.g., a delivery room in a hospital), any suitable blood loss protocol may be used to provide guidance to a user in any medical procedure. In some example embodiments, the blood loss protocol may be or include a protocol for managing the patient's bleeding risk. In other example embodiments, the blood loss protocol may be related to other types of risks associated with blood loss during a procedure (e.g., a medical procedure).

[0035] A blood loss protocol (such as a blood loss protocol for managing bleeding risk) may be divided into multiple patient stages. In some example embodiments, the patient stages of the blood loss protocol are based on the estimated severity of the patient's blood loss. Each stage may be associated with one or more ranges of patient blood loss values, and each range may be defined by an upper threshold blood loss value, a lower threshold blood loss value, or both. Figure 2 is a schematic depiction of a blood loss protocol 200 that is divided into four patient stages 210, 220, 230, and 240. Each patient stage has a patient stage number (e.g., 1, 2, 3, 4) based on the severity of the patient's blood loss, the bleeding risk, or both. For example, patient stage 1 may represent the lowest bleeding risk, while patient stage 4 may represent the highest bleeding risk. One or more patient stages may be defined by a range of blood loss values (e.g., a corresponding range). In Figure 2In [the context], if the estimated blood loss falls within the range 212 defined by the thresholds (a) and (b), then the patient is classified as patient stage 1. Similarly, if the estimated blood loss falls within the range 222 defined by the thresholds (c) and (d), then the patient is classified as patient stage 2. If the estimated blood loss falls within the range 232 defined by the thresholds (e) and (f), then the patient is classified as patient stage 3. If the estimated blood loss falls within the range 242 defined by the thresholds (g) and (h), then the patient is classified as patient stage 4. Additionally or alternatively, one or more patient stages may be associated with one or more other suitable patient criteria (e.g., the number of packed red blood cells (PRBCs) administered, vital sign values, etc.), such that the patient can be classified into an appropriate current patient stage based on the estimated patient blood loss, one or more other suitable patient criteria, or any suitable combination thereof.

[0036] In some example embodiments, multiple ranges (e.g., ranges of more than one discrete blood loss value) may be associated with the same patient stage within a blood loss protocol. Different patients, procedures, or conditions can affect the risks posed by different blood loss values. Thus, each patient stage may be associated with multiple ranges. Each range may be associated with a medical procedure, patient condition, patient status, or any suitable combination thereof. For example, each stage may be associated with a first range defined by threshold blood loss values for patients undergoing vaginal delivery and a second range defined by a second set of threshold blood loss values for patients undergoing cesarean section. The various ranges associated with each stage can account for any suitable parameters. For example, for males versus females, patients with different BMI classifications, children versus adults, patients exhibiting a particular disorder or risk factor versus patients not exhibiting a particular disorder or risk factor, or any suitable combination thereof, each stage may be associated with different ranges.

[0037] Each patient stage of the blood loss protocol can include one or more elements of that patient stage. In some example embodiments, each element can be or include a recommended action to be performed by a user to effectively manage a patient's blood loss. For example, an element of a patient stage of the blood loss protocol can be or include recommending to the user: contact a blood bank to request an amount of blood for transfusion, initiate a blood transfusion, request additional support staff, apply pressure to a wound, suture or dress the wound, administer an IV, perform a massage or other type of therapy, apply an ointment, administer a drug (e.g., orally or otherwise), or any suitable action. An element of a patient stage can also be or include one or more non-action items, such as notifying the user of the patient's blood type, notifying the user of the patient's allergies, advising the user of an approximate time when a blood transfusion may be necessary if the patient's blood loss continues at a specific rate, or any suitable combination thereof. An element can also be or include an instruction to observe or monitor various parameters, such as one or more vital signs of the patient (e.g., heart rate, oxygen level, temperature, etc.). Figure 2 Elements 214a - 214c in patient stage 1, elements 224a - 224d in patient stage 2, elements 234a - 234b in patient stage 3, and elements 244a - 244e in patient stage 4 of the blood loss protocol 200 are shown. As Figure 2 depicted, the number of elements in each patient stage of the blood loss protocol 200 need not be uniform; different patient stages can have different numbers of elements. Additionally, each patient stage can include any suitable number of elements. In some example embodiments, one or more elements of the blood loss protocol can be sorted in a particular manner, such as in the order in which the corresponding actions of the elements should be performed. For example, Figure 2 patient stage 1 in shows elements arranged in a flowchart. In other example embodiments, the elements may not be sorted in the blood loss protocol (e.g., in scenarios where the order of the elements depends on user input). Additionally, certain elements can appear in multiple stages. That is, each element need not be unique to a particular stage. For example, it may be desirable to perform a blood transfusion in both patient stage 3 and stage 4. Thus, both patient stages 3 and 4 can include an element that recommends the user perform a blood transfusion.

[0038] Figure 11 An example embodiment of a blood loss protocol that can be used to provide guidance to a user is depicted. Figure 11 The blood loss protocol shown in has four patient stages 1010, 1020, 1030, 1040, and each patient stage is associated with one or more ranges of blood loss values, which can be referred to as "criteria". As discussed above, based on various factors (such as the patient's condition), a series of blood loss values can be associated with more than one patient stage. For example, Figure 11The patient stage 1 (1020) of the protocol is associated with two blood loss ranges, one for vaginal delivery (> 500 mL blood loss) and another for cesarean section (> 1000 mL blood loss). Each patient stage of the protocol is associated with multiple elements. For example, stage 2 (1030) of the blood loss protocol includes several elements that are recommended actions that can guide a user to perform when the patient's blood loss falls within the range associated with patient stage 2 (1020). For example, in patient stage 2, the user is instructed to call an obstetrician (OB) to the patient's bedside, obtain additional care providers, administer oxytocin, notify the blood bank, etc. In some example embodiments, not all elements in a given patient stage are suitable for every patient. For example, some elements in patient stage 2 are specific to the type of delivery performed (e.g., if vaginal, then repair vaginal tears, perform a D&C, and place an intrauterine balloon; if cesarean, then examine the site and place an intrauterine balloon). However, Figure 11 The blood loss protocol depicted in

[0039] One or more blood loss protocols may be stored in the memory of one or more devices. In some example embodiments, one or more blood loss protocols are stored in the memory of a mobile computing device (such as a smart phone, laptop computer, or tablet). In some example embodiments, one or more blood loss protocols are stored in the memory of a remote device and may be accessed wirelessly. For example, the blood loss protocol may be stored in a cloud-based storage system. A user may upload the blood loss protocol to the memory of a computing device in any suitable manner. In some example embodiments, the blood loss protocol is customizable. For example, one or more user settings may allow a user to adjust one or more parameters of the blood loss protocol. In some example embodiments, a user may be able to set thresholds for ranges or other patient criteria associated with one or more patient phases of the blood loss protocol. As another example, one or more user settings may allow a user to adjust one or more elements of the blood loss protocol (e.g., a customizable set of recommended actions for one or more patient phases). Such user settings may enable, for example, a hospital or practitioner to customize the blood loss protocol for their purposes (e.g., generally as a default protocol, for a specific patient demographic, for a specific procedure type, etc.). In some example embodiments, the blood loss protocol may be automatically adjusted (e.g., by suitable software executed on a suitable device) based on patient information (such as height, weight, gender, medical history, surgical information, or any suitable combination thereof). Information about the patient, medical procedure, or any other suitable information for customizing the blood loss protocol may be manually input by the user or may be received by other means (e.g., electronic or wireless transmission). Additionally, an updated version of the blood loss protocol may be downloaded to the server and memory automatically or by the user.

[0040] Example of estimated blood loss

[0041] One or more of the example methods described herein for guiding a user may include estimating a patient's blood loss. Various example methods may be used to estimate the amount of blood lost by a patient during a medical procedure. In some example embodiments, two or more such methods may be combined to arrive at an estimated patient blood loss. In some example embodiments, one or more image analysis techniques are used to estimate patient blood loss.

[0042] For example, as further described below, estimating blood loss can include analyzing an image depicting one or more fluid-containing substrates, such as a fluid container, a surgical article (e.g., a surgical fabric such as a surgical sponge), or both. Estimating blood loss can include extracting features (such as color parameters) from the image and correlating the feature with an estimated concentration of a blood component. The estimated concentration of the blood component can be used to determine the volume of fluid in the fluid-containing substrate. The volume of fluid in the substrate can be used to determine the total blood loss of the patient, either alone or in combination with the estimated volume of fluid in other fluid-containing substrates (e.g., among a plurality of such substrates). As another example, as further described below, estimating blood loss can alternatively or additionally include using weight information to determine the estimated blood loss of the patient. For example, estimating blood loss can include weighing one or more fluid-containing substrates (e.g., surgical articles, fluid containers, etc.) and correlating the weight information with the amount of blood lost by the patient. In some example embodiments, the weight information can be combined with information derived from one or more image analysis techniques to determine the estimated blood loss of the patient. As yet another example, one or more manual methods of estimating blood loss can be used, such as using one or more containers with level markings. Thus, one or more of the example methods discussed herein can include analyzing a plurality of fluid containers, surgical articles, or both to estimate the blood loss of a patient.

[0043] Example image analysis techniques for estimating blood loss

[0044] In some example embodiments, estimating the blood loss of a patient includes using one or more image analysis techniques to determine the amount of blood in one or more fluid-containing substrates, such as one or more fluid containers, surgical articles (e.g., surgical fabrics or sponges, etc.), or any suitable combination thereof. For example, estimating the blood loss of a patient can include one or more of the methods described in U.S. Patent No. 8,792,693 and U.S. Patent No. 8,983,167, which are hereby incorporated by reference in their entirety. Generally, as Figure 3 depicted in the schematic block diagram of, a method 300 for estimating the blood loss of a patient using one or more images depicting one or more fluid-containing substrates can include receiving 310 an image of the fluid-containing substrate, selecting 320 a region of the image that includes at least a portion of the fluid-containing substrate, extracting 330 features from the selected region, correlating 340 the extracted features with the concentration of a blood component within the substrate, and estimating 350 the amount of the blood component within the substrate based on the concentration of the blood component within the substrate.

[0045] For example, as Figure 3As shown in [Figure 0], the method 300 for estimating blood loss can include receiving 310 an image of a fluid matrix. The image can be static, a video (e.g., a color frame of a live video), infrared, a field of view of an optical sensor, black and white, a fingerprint of a field of view of an optical sensor, a point cloud, any other suitable type of image, or any suitable combination thereof. Any suitable device can be used to generate the image, receive the image, perform any subsequent image processing, or any suitable combination thereof. For example, a camera on a mobile computing device can be used to generate an image of a fluid matrix. A processor (e.g., the processor of the mobile device) can receive the image, perform image processing and analysis, or both, to estimate blood loss. The image can depict all or part of the fluid matrix, and the image can depict multiple fluid matrices. Figure 3 The example method depicted in [Figure 1] includes selecting 320 a region of the image. The selection of the region of the image can include selecting the region in the image corresponding to the fluid matrix. For example, one or more region selection methods can utilize edge detection techniques, machine learning, or both to identify and isolate the fluid matrix in the image. The selection of the region of the image can include identifying a portion of the image that contains blood or other fluid. For example, the selection of the region of the image can include detecting the liquid level in a tank or other fluid container and isolating the portion of the image corresponding to the fluid, detecting and isolating the fluid-saturated portion of a surgical item (such as a surgical fabric), or any suitable combination thereof.

[0046] Figure 3 The example method 300 depicted in [Figure 2] further includes extracting 330 features from the selected region of the image. The extracted features can be features indicative of the concentration of blood components in the fluid matrix. The extracted features can be a color (e.g., red), color intensity (e.g., red value), luminance, hue, saturation value, brightness value, glossiness value, or other color-related value in one or more component spaces (such as red, blue, green, cyan, magenta, yellow, key, or laboratory component spaces). In some example embodiments, the extraction of the features can include extracting one or more features that result in the generation of a histogram of various colors or color-related values in a set of pixels within the selected region of the image.

[0047] Figure 3The example method 300 depicted also includes correlating 340 the extracted features with the concentration of a blood component of a fluid-containing substrate. Generally, correlating the extracted features with the blood component concentration may include correlating the extracted features with a value indicative of the amount of blood in the fluid-containing substrate. For example, correlating the extracted features with a value may include transforming one or more features (e.g., color features) extracted from an image into an estimated concentration of a blood component within the fluid-containing substrate (e.g., a fluid tank or a surgical article). The blood component may be any one of whole blood, red blood cells, hemoglobin, platelets, plasma, white blood cells, or any other blood component. For example, transforming one or more features into an estimated concentration of a blood component may be implemented or otherwise based on one or more parametric analysis techniques, non-parametric analysis techniques, such as those described in U.S. Patent No. 8,983,167 and U.S. Patent No. 8,792,693, respectively, or any suitable combination thereof, to estimate the concentration of the blood component in the fluid within the fluid-containing substrate (e.g., a fluid tank).

[0048] As Figure 3 shown, the example method 300 involves extracting 330 one or more features (e.g., from a pixel cluster) within a selected region of an image. In some example embodiments, this is followed or otherwise accompanied by labeling each pixel cluster with a blood volume indicator based on the non-parametric correlation of each pixel cluster with a template image in a library of template images of known blood component concentrations. For example, estimating the blood component concentration may involve extracting the color intensity in the red component space from a set of pixel clusters and implementing a K-nearest neighbor method to compare each extracted feature with the red intensity value of a template image. Each template image may include pixel clusters labeled with a known fluid mass, such as hemoglobin volume or mass per unit volume of fluid or per pixel unit (e.g., hemoglobin concentration). Each template image may include pixel clusters labeled with volume, mass, density, etc., of any other liquid or solid in the tank per unit volume of fluid or per pixel unit. Once a suitable match between a particular pixel cluster and a particular template image is identified, the estimation of the blood component concentration may include projecting the known fluid mass information from the particular template image onto the particular pixel cluster. Thus, the selected image region, pixel, pixel cluster, or any suitable combination thereof may be paired with the template image of the closest match identified by the K-nearest neighbor method, and the selected image region, pixel, pixel cluster, or combination thereof may be estimated to depict the blood component concentration associated with the closest match template image. The estimation of the blood component concentration may also aggregate, average, or otherwise combine the pixel cluster labels to estimate an output of the total blood component concentration of the fluid in the fluid-containing substrate. However, various example embodiments of the methods discussed herein may include correlating the extracted features with the concentration of the blood component within the substrate via any other suitable non-parametric method or technique.

[0049] In another example, the absolute difference in pixel intensity (e.g., red, green, or blue intensity or color value, or any suitable combination thereof) can be used for template matching. This absolute difference in pixel intensity can be calculated at a light wavelength associated with the blood component (e.g., at approximately 400 nm for estimating hemoglobin concentration). More specifically, the sum of the absolute differences in pixel intensity can be used to compare the pixel intensity between the container image region and each template image. When the sum of the absolute differences is substantially the smallest compared to the sums of the other absolute differences calculated for the image region and other template images, the most closely matching template image is identified. Thus, the image region can be paired with the most closely matching template image identified by the sum-of-absolute-differences method, and the image region (e.g., pixel cluster) can be estimated to depict the same blood component concentration associated with the most closely matching template image.

[0050] In yet another example, the estimation of blood component concentration can include extracting features from pixel clusters within a selected region of the image and implementing a parametric model or function to label each pixel cluster with a blood component concentration. As described in U.S. Patent No. 8,792,693, the estimation of blood component concentration can include inputting (e.g., inserting) one or more extracted features from a pixel cluster into a parametric function to substantially directly transform the one or more extracted features from the pixel cluster into a blood component concentration. This process can be repeated for each other pixel cluster in the selected region. As mentioned above, one or more of the extracted features can include any one or more of the color intensity in the red component space, the color intensity in the blue component space, the color intensity in the green component space, or any suitable combination thereof. The parametric function can be or include a mathematical operation or algorithm that associates the color intensity with the mass of hemoglobin per unit volume of fluid. Generally, the color values of the template images can be used to train or generate a parametric model (e.g., in the form of a mathematical function, curve, or algorithm) that associates pixel color values with blood component concentration.

[0051] The reflectance of oxyhemoglobin (HbO2) at certain wavelengths of light can indicate the hemoglobin concentration per unit volume of fluid. Thus, in some example embodiments, for each pixel cluster in a set of pixel clusters in a selected region of an image, the extracted feature can be or include one or more reflectance values at a particular wavelength. The association of the extracted feature with the concentration can include converting each reflectance value into a corresponding hemoglobin concentration value by implementing a parametric model. The hemoglobin concentration values can be combined to estimate the total (e.g., average) hemoglobin concentration in the fluid-containing matrix. Additionally, since the hemoglobin content of wet (e.g., hydrated) red blood cells is typically about 35%, the red blood cell concentration can be inferred from the hemoglobin concentration based on a statically estimated hemoglobin content (e.g., 35%). Further, extracting features from the selected region can include accessing a most recently measured hematocrit or estimating the patient's current hematocrit (e.g., as described in U.S. Patent No. 9,936,906, which is incorporated herein by reference in its entirety), and the association of the extracted features can utilize the measured or estimated hematocrit to transform the estimated red blood cell concentration into an estimated in vitro blood concentration. However, the association of the extracted features with the blood component concentrations can implement any other parametric analysis, non-parametric analysis, or both on individual pixels or pixel clusters within the selected region to estimate the concentration of any one or more blood components in the fluid within the fluid-containing matrix (e.g., fluid tank).

[0052] Estimation of the amount of blood components in a fluid-containing matrix 350 can include determining the total volume of fluid contained within the matrix. In some example embodiments, information regarding the weight of the matrix, the liquid level in the matrix, the dimensions of the matrix, or any suitable combination thereof can be used to determine the fluid volume within the matrix. For example, weight information can be combined with a known approximate density of the fluid in the matrix to obtain the fluid volume of the fluid within the matrix. In another example, the liquid level of a matrix in the form of a tank in combination with the dimensions of the tank can be used to determine the volume of fluid in the tank. In another example, the dimensions of a surgical article (e.g., surgical fabric) can be used to determine the surface area of the surgical article, which can be combined with information regarding the saturation level and blood component concentration to determine the volume of fluid in the surgical article.

[0053] In some exemplary embodiments, estimating the blood content in a fluid-containing substrate includes estimating the blood content at least in part based on the liquid level in a container (e.g., a fluid tank), which can form all or part of the fluid-containing substrate. For example, the liquid level in the container can be used to determine the volume of fluid in the container, which can be used to calculate the amount of blood in the container (e.g., in combination with the concentration of blood components). In some example embodiments, the liquid level or fluid volume in the container can be determined by receiving such information via user input. Additionally or alternatively, the liquid level or fluid volume can be estimated by one or more processors. Estimating the liquid level in the container can involve correlating a portion of a selected region of an image with the liquid level within the tank. For example, estimating the liquid level can include identifying the surface of the fluid in the tank and the base of the tank (e.g., the lowest extent of the fluid in the tank), and estimating the liquid level within the tank based on this data. In some example embodiments, the processor can fit a parametric function (e.g., sigmoid) to the intensity distribution of the selected region corresponding to the anti-glare strip on the tank to estimate the fluid height therein. In other example embodiments, the processor can correlate the pixels in the selected region with the fluid (e.g., pixels that are substantially red) and calculate the upper and lower limits of the fluid in the tank based on the distribution of the y-coordinates of the correlated pixels. In such example embodiments, the processor can define the upper limit as the 95th percentile of the y-coordinates, or the processor can start at the 99th percentile of the y-coordinates of the correlated pixels and decrement the percentile until the redness of two adjacent pixels does not change by more than a predetermined threshold, but the process can function in any other way to identify, ignore, or both any "false positive" "red" pixels that do not correspond to the fluid in the tank.

[0054] In some exemplary embodiments, estimating the blood content in a fluid-containing substrate includes estimating the blood content at least in part based on an estimated blood volume in an estimated fluid-containing substrate (such as a surgical article (e.g., a surgical fabric)) by generating information about the dimensions of the surgical article (e.g., the estimated surface area of the surgical article, the estimated surface area of the soiled portion of the surgical article, the pixel count of a portion of the surgical article, the pixel count of the soiled portion of the surgical article, or any suitable combination thereof). In some example embodiments, estimating the blood content in a fluid-containing substrate can implement object recognition to isolate an object within the field of view of an optical sensor, within an image, or both. The object can have known dimensions, or the dimensions of the object can be extrapolated, such as by estimating the distance from the optical sensor, the angle between the optical sensor and an object with known dimensions, or both, and comparing the position of the fluid-containing substrate in the image with the position of the object with known dimensions. In other example embodiments, determining the dimensions of the fluid-containing substrate can involve determining the number of pixels along an axis of the fluid-containing substrate and using information about the distance from the optical sensor to the fluid-containing substrate to establish a relationship between the number of pixels and a numerical dimension.

[0055] Estimation of the amount of blood in a fluid matrix 360 can utilize the concentration of blood components in the fluid matrix (e.g., related or otherwise determined based on extracted features) and the total fluid volume in the determined matrix to estimate the amount of blood components in the fluid matrix. Generally, the estimation of the amount of blood components can include calculating the amount of blood components (e.g., mass, weight, volume, cell count, etc.) by multiplying the estimated fluid volume in the fluid matrix by the estimated concentration of the blood component in the fluid in the fluid matrix (e.g., a can). Additionally, the estimated blood loss (e.g., lost blood volume) can be estimated by dividing the estimated amount of a blood component (e.g., hemoglobin) by a value of the serum blood component mass value, which can be, for example, laboratory-derived and entered by the user.

[0056] Estimation of patient blood loss can also include combining blood volume estimates from multiple matrices. For example, the estimation of total patient blood loss can include adding the estimated blood volumes in multiple fluid matrices. The estimation of patient blood loss can include combining blood volumes from the same type of fluid matrix (e.g., two or more fluid cans) or different types of matrices (e.g., combining a can blood volume estimate with the blood volume in estimated surgical items such as surgical gauze sponges, surgical drapes, surgical sheets, surgical dressings, or any suitable combination thereof). The example methods discussed herein can include adding estimated patient blood loss data to the patient's case, triggering an alert once a threshold extracorporeal blood volume estimate is reached, or estimating the current patient hematocrit based on the initial patient hematocrit, fluid IV, transfusions, and estimated total blood loss, such as described in U.S. Patent No. 9,936,906.

[0057] Other examples of estimating patient blood loss

[0058] Some methods for estimating patient blood loss may not utilize image analysis. However, as described above, one or more techniques involving image analysis can be combined with other techniques to estimate patient blood loss.

[0059] In addition to using the above-described weight information (e.g., combining the weight information with the blood component concentration derived from the extracted image features to estimate the blood content of the substrate), the weight information can be used to estimate the patient's blood loss without using image analysis. For example, the weight of one or more fluid-containing substrates can be used to estimate the amount of blood contained in the one or more fluid-containing substrates using predetermined information about the blood content of the one or more fluid-containing substrates. In some cases, it can generally be assumed that all or substantially all of the fluid contained in the substrate is blood (e.g., human blood). The known density of such blood can be used to relate the fluid weight in one or more fluid-containing substrates (e.g., as estimated as the difference between the "wet" weight and the "dry" weight of the fluid-containing substrate) to the fluid volume. In other cases, the blood component concentration in the fluid can be known with a reasonable level of certainty without using image analysis, and the blood component concentration can be used to estimate the amount of blood in the fluid-containing substrate. Any suitable weight detection system or method can be used to determine the weight of the substrate configured to contain the fluid. For example, one or more such methods can include placing an item (such as a fluid container or a surgical fabric) on a scale to determine the weight. In some example embodiments, the weight information (e.g., indicating the weight) can be received by a processor to estimate the amount of blood contained in the fluid-containing substrate based on the weight information. The weight information can be automatically transmitted to the processor (e.g., wirelessly transmitted from the scale) or can be manually input by a user (e.g., input into a computing device such as a smart phone, a tablet computer, a laptop computer, etc.).

[0060] In some example embodiments, one or more manual techniques can be used to estimate the patient's blood loss. For example, blood can be collected into a fluid tank, and a volume indicator (e.g., a marking) on the tank can be used to estimate the amount of blood in the tank. The fluid tank can be placed in a location close to the patient such that the blood lost by the patient can drain into the tank. The user can observe one or more markings on the tank, and when the fluid reaches the liquid level of each marking, the one or more markings can indicate the fluid volume in the tank. In some example embodiments, the user manually inputs the volume (e.g., indicated by the liquid level) into a processor (e.g., the processor of a mobile computing device). In other example embodiments, one or more imaging systems, liquid level sensors, or any suitable combination thereof determine when the fluid reaches a specific liquid level of the tank and automatically transmit the liquid level information to the processor.

[0061] U.S. Patent Publication No. 2018 / 0199827, which is incorporated herein by reference in its entirety, describes examples of non-image-based methods for quantifying the fluid lost by a patient during a medical procedure (e.g., during childbirth, surgery, etc.). One or more of various methods, systems, or both can be used to track or otherwise estimate the amount of fluid (e.g., blood) lost by a patient throughout a medical procedure, and this estimate can be updated and displayed substantially in real time during the medical procedure, at the end of the medical procedure, or both. During a medical procedure, extracorporeal fluid (e.g., blood) lost by the patient can be collected along with surgical items. Examples of such surgical items include surgical fabrics or other absorbent surgical items, such as surgical sponges (e.g., laparotomy sponges), surgical dressings, surgical gauze, surgical towels, absorbent pads or drapes (e.g., chux pads), vaginal packs, other fabrics, other absorbent items, or any suitable combination thereof. One or more surgical fabrics or other absorbent surgical items can be placed in a bag (e.g., a sponge count bag) for tracking purposes, hygiene purposes, or both. Additionally or alternatively, the extracorporeal fluid lost by the patient can be collected in a container (e.g., a fluid container), such as a can (e.g., a fluid can). Some applications of such methods and systems can involve collecting the lost fluid in a specialized container. For example, during a childbirth procedure, a sheet having at least one pocket (e.g., a blood collection sheet having a triangular pocket) can be placed under the patient to collect blood, amniotic fluid, urine, or any suitable combination thereof. The amount of fluid collected in at least some types of surgical items (such as surgical fabrics or fluid cans) can be estimated based on the weight (mass) measured when the surgical item contains the fluid, or can be measured based on a volume indicator or markings on the surgical item (e.g., on a fluid can). In some embodiments, multiple batches of such items are weighed (e.g., when each batch of one or more surgical fabrics becomes saturated) and aggregated into a running total or overall estimate of the amount of fluid lost by the patient during the medical procedure. This estimate can be combined with the estimates of fluid collected in batches or cumulatively over time in some other types of surgical items (such as cans or blood collection sheets). For example, the total volume of fluid, the total rate of fluid loss, or both can be estimated at any particular point during the medical procedure, after the procedure, or both.

[0062] Example of determining the current patient stage of the blood loss protocol

[0063] Guiding a user during a medical procedure may include determining a current patient stage of a blood loss protocol. The determination of the current patient stage may be based on an estimated patient blood loss. As described above, one or more of a variety of methods may be used to determine the estimated patient blood loss. The determination of the current patient stage of the blood loss protocol may include comparing the estimated patient blood loss to a threshold of a blood loss range associated with each patient stage of the blood loss protocol, evaluating the patient against other patient criteria (e.g., rate of blood transfusion, vital signs, or both), or any suitable combination thereof. In some example embodiments, each patient stage of the blood loss protocol is associated with more than one range. Thus, the determination of the current patient stage may also include selecting an appropriate range to compare to the estimated patient blood loss. Additionally, as described above, multiple medical parameters may be used to determine the current patient stage of the blood loss protocol.

[0064] In some example embodiments, a processor may receive the estimated patient blood loss, access the blood loss protocol stored in the device's memory, and compare the estimated patient blood loss to a threshold associated with each range of the blood loss protocol to determine the current patient stage. The processor may then transmit the current patient stage to one or more subsequent method steps such that one or more processors may utilize the current patient stage to provide guidance to the user. In some example embodiments, the estimated patient blood loss is automatically transmitted to the processor. For example, in an implementation where the estimated patient blood loss is estimated using one or more computerized methods (such as those described above (e.g., image analysis, analyzing weight information, etc.)), the estimated patient blood loss may be automatically transmitted to and received by the processor for providing guidance to the user. The components of the blood loss estimation system and the components for determining the current patient stage may communicate with each other in any suitable manner. For example, a transmitter / transceiver of the blood estimation system may communicate with a transmitter / receiver of the system to determine the current patient stage (e.g., wirelessly or via wired communication). In some implementations, the blood loss estimation and the determination of the current patient stage may be performed on the same system, the same processor, or both. In some example embodiments, the determination of the current patient stage includes accessing data associated with the estimated blood loss from the memory of one or more devices.

[0065] In other example embodiments, the estimated patient blood loss can be manually entered by the user, adjusted or updated by the user, or both. For example, in cases where one or more manual techniques are used to estimate patient blood loss, such as by using markings on a fluid container to determine blood volume, using weight information to estimate blood loss, or both, the user may wish to manually enter the patient blood loss into the system for determining the current patient stage. Additionally, in some example embodiments, the user may wish to adjust or update the automatically transmitted patient blood loss. For example, it may be the case that the patient blood loss was determined by a processing system using images of a fluid canister, surgical fabric, or both, but the system did not capture additional blood loss information. The user may then wish to add the additional blood loss to the estimate. Figure 14 An example of the GUI 1300 is shown that allows the user to manually enter a blood loss value from a fluid container or enter a fluid volume value from which a blood loss value can be derived. Figure 14 The GUI 1300 in [reference] allows the user to use one slider icon 1310 to adjust the volume of a first fluid (e.g., amniotic fluid) in a fluid container (e.g., a V - drape) and use another slider icon 1320 to adjust the total volume of fluid in the fluid container. For example, the position of a marker along the slider icon 1310, the slider icon 1320, or both can be adjusted by the user clicking and dragging the marker itself, by selecting increment or decrement buttons, or both. In the depicted example, the blood loss value can be determined as the difference between the total fluid volume entered via the slider icon 1320 and the amniotic fluid volume entered via the slider icon 1310 (e.g., assuming the two main fluids in the fluid container are amniotic fluid and blood). When the user has finished adjusting the values for each metric, the user can press the "Set Values" button 1330 to store the information entered by the user, the fluid amounts derived therefrom (e.g., the blood loss value), or both. While Figure 14 The GUI 1300 is shown allowing the user to enter the amount of fluid contained in a V - drape, but a similar display can be used to allow the user to enter the amount of fluid (e.g., blood) in any type of container. Similarly, while the GUI 1300 includes slider icons (e.g., slider icons 1310 and 1320) to allow adjustment of fluid volume, it should be understood that other input mechanisms (e.g., typing a numerical value, reciting numbers to be parsed using speech recognition technology, etc.) can be appropriately used.

[0066] For example, a processor may receive an estimated patient blood loss value for Patient A with 1200 mU of blood. The blood loss protocol stored in the memory of the computing device may include three (3) patient blood loss stages. Patient stage 1 of the blood loss protocol may be associated with a range of 500 mU - 1000 mU; patient stage 2 may be associated with 1000 mU - 1500 mU; and patient stage 3 may be associated with > 1500 mU. Thus, one or more methods of determining the current patient stage may include comparing the estimated blood loss of Patient A with thresholds that define the range associated with patient stage 1, the range associated with patient stage 2, and the range associated with patient stage 3. Based on the comparison, the processor will determine that the estimated blood loss of 1200 mU for Patient A falls between the thresholds of 1000 mU and 1500 mU, and thus the current patient stage should be patient stage 2. However, it should be understood that these blood loss value ranges are merely examples, and other threshold blood loss values may be used to determine which stage is the current patient stage.

[0067] Example of providing guidance

[0068] One or more of the methods discussed herein may include providing guidance to a user based on one or more of the current patient stage of the blood loss protocol, one or more user inputs, or any suitable combination thereof. Providing such guidance may include selecting one or more elements from the current patient stage of the blood loss protocol. As described above, each patient stage may include one or more elements that may be selected by the processor. In some example embodiments, one or more elements of the current patient stage of the blood loss protocol may be or include one or more recommended user actions.

[0069] Example of determining the guidance to be provided to the user

[0070] Figure 4 is a schematic depiction of a method 400 for providing guidance to a user. Generally, providing guidance to a user includes selecting 412 one or more elements from a patient stage (e.g., patient stage 410, 420, 430, or 440) to provide as guidance. In Figure 4In the example embodiments shown, the guidance 416 includes four elements selected from the patient stage 420. However, any suitable number of elements can be selected to provide the guidance. In some example embodiments, one or more elements to be included in the guidance are selected based on the current patient stage. In other example embodiments, one or more elements to be included in the guidance are selected based on the current patient stage in combination with user input. For example, such user input can include information about the patient (e.g., parameters such as height, weight, gender, physical condition, medical history, family history, preoperative platelet count, preoperative hematocrit, preoperative hemoglobin, vital signs, or any suitable combination thereof), the medical procedures being performed on the patient, the hospital, the doctor, one or more actions the user has performed, or any suitable combination thereof. For example, the user input can indicate that the patient is obese and thus at a higher risk of blood loss-related complications.

[0071] Based on this information about the patient and based on the current patient stage, the guidance can include an element recommending that the user prepare for a blood transfusion. The user input can be received in any suitable manner, such as the user interacting with a mobile computing device (e.g., pressing one or more buttons on the mobile computing device to indicate the completion of an element of the blood loss protocol). In some example embodiments, information about the patient, the medical procedure, the hospital, one or more doctors, one or more actions performed by the user, or any suitable combination thereof can be automatically transmitted to and received by one or more processors. Thus, "user input" can be data that is automatically transmitted based on actions performed by the user, information obtained by the user, items manually entered by the user, or any suitable combination thereof.

[0072] In some example embodiments, one or more patient stages can include one or more elements that are conditionally selectable for being provided as guidance. For example, one or more elements can be selected based on an indication that the user has performed one or more specific actions or one or more specific events have occurred (e.g., the one or more elements are not selectable until such performance or occurrence). In other words, specific one or more actions or events can "unlock" one or more conditionally selectable elements and enable these one or more unlocked elements to be provided as guidance to the user later. The conditionally selectable element 418 is in Figure 4is schematically depicted by a dashed line. However, after one or more events, user inputs, or both occur, one or more conditionally selectable elements can be reclassified as selectable. If certain elements are relevant under restricted circumstances, it may be desirable to classify those elements as non - selectable (e.g., not selectable or otherwise not available for selection) until or unless a specific event occurs. For example, some elements may be relevant only when the user indicates that they have started a blood transfusion, are performing an IV transfusion, or have started suturing a wound. Similarly, one or more patient phases can include conditionally non - selectable elements (e.g., the element is disabled such that, although the user selects the element, the functionality associated with the element is not performed) as a guide. For example, after an indication that the user has performed a specific action or a specific event has occurred, one or more elements may be non - selectable or hidden (e.g., one or more elements were selectable prior to this action or event). In other words, a specific action or event can "lock" one or more conditionally non - selectable elements and disable these one or more locked elements, thus preventing them from being provided to the user as a guide later. Thus, depending on one or more predefined triggers (e.g., actions, events, or any suitable combination thereof), one or more elements can be unlocked (e.g., become available as a guide) or locked (e.g., become unavailable as a guide).

[0073] In some example embodiments, providing guidance to a user includes providing updated guidance to the user. The updated guidance can be provided based on any suitable indication or event (such as user input, an updated current patient blood loss phase, or any suitable combination thereof). The updated guidance can be provided based on user input. For example, the user can indicate that the user has performed a specific action, the patient has exhibited a certain condition, or both, which can prompt an updated list of elements to be selected for providing to the user and then provided to the user. In some example embodiments, the updated guidance can be provided based on an updated patient phase of a blood loss protocol. For example, an estimate of blood loss can include continuously or periodically estimating the patient's blood loss (e.g., the blood loss of a patient undergoing a medical procedure). Thus, an updated estimate of the patient's blood loss can be determined at various time points during the medical procedure, and an updated patient phase can be determined based on the updated patient blood loss. Thus, updated guidance can be provided to the user based on the updated patient phase, as updated based on the updated blood loss. In some example embodiments, the updated guidance can be provided to the user or patient, e.g., based on both user input and an updated patient phase (e.g., based on the updated blood loss).

[0074] Figure 5Schematic diagram of a method 500 for providing guidance to a user, where providing guidance includes providing 530 initial guidance and providing 560 updated guidance. As described above, the method 500 for providing guidance to a user may include estimating 510 the blood loss of a patient, determining 520 the current patient stage of a blood loss protocol based on the estimated blood loss, and providing 530 guidance to the user based on the current patient stage. As indicated by the dashed arrow pointing from the provision 530 of guidance, providing updated guidance may be based on one or more types of information. Providing updated guidance may include estimating 540 the updated blood loss of the patient and determining 545 the updated patient stage of the blood loss protocol based on the updated blood loss. In some example embodiments of the method 500, the provision 560 of updated guidance includes receiving 550 user input. Thus, the provision 560 of updated guidance may be based on user input, the updated patient stage (e.g., updated based on the patient's updated blood loss), or both.

[0075] Example of providing determined guidance

[0076] Providing guidance (e.g., including any updated guidance) may include displaying or otherwise presenting to the user the guidance, other information, or both. For example, providing guidance to the user may include displaying on a display (e.g., a display screen) one or more elements selected by a processor. The display may be a display screen that is part of a mobile computing device (such as a tablet computer, laptop computer, smart phone, or any suitable computing device). As another example, the display may be part of a desktop computing console, etc. Additionally or alternatively, providing guidance to the user may include displaying the guidance on a projection surface (e.g., a wall, a projector screen, etc.). The guidance may be displayed near the patient (e.g., in the same room), outside a medical procedure room, such as near a medical department desk (e.g., a nurse's station), a lounge, a common area, etc. Such that medical staff outside the immediate vicinity of the patient can be aware of the guidance provided, the status of the patient (e.g., in a substantially real-time manner), or both.

[0077] Figure 6 An example of a GUI of a display screen of a mobile device for displaying various elements of a blood loss protocol is depicted. Figure 6 An example GUI depicts a series of elements of the current patient stage provided to the user (which is "Stage 2" in Figure 6 ). As depicted in Figure 6 , the display may provide one or more elements that include one or more recommended actions for the user to complete. The display may provide one or more complete, incomplete, or any suitable combination thereof, and may include an indication of whether the action has been completed. For example, the display may include a box adjacent to each element such that completed elements may be indicated by a mark.Figure 6 A box with completed items indicated by "x" is shown, but any suitable marker can be used (e.g., checkmark, slash, asterisk, filled box, text of a struck-out element, etc.). As described above, one or more elements can be marked as completed automatically or via user input (e.g., by manual user input via a touch screen, by the recited user input that can be parsed and interpreted, etc.). In some example embodiments, the display presents elements in one or more of various colors to indicate whether they have been completed (e.g., green items are completed while red items need to be completed). The display can adjust the color intensity based on whether an element has been completed (e.g., uncompleted elements are listed in a darker color or black, while completed elements are lightened or grayed). Figure 12 Another example GUI (e.g., a display screen for a mobile computing device) depicting various elements of a blood loss protocol is shown. Figure 12 The GUI in [description] depicts a series of example elements provided to a user for the patient phase (labeled "Phase 1") of the blood loss protocol.

[0078] The elements of the guidance shown can be arranged in any suitable manner. In some example embodiments, some or all of the elements can be grouped into categories and presented in conjunction with one or more of various headings. For example, some or all of the elements can be grouped into categories such as assessment (e.g., assessing cumulative blood loss, assessing the vaginal wall, assessing the cervix, assessing the placenta, assessing the uterine cavity, measuring the patient's vital signs, etc.), medications (e.g., administering 250 megagrams of misoprostol), notifications (e.g., notifying the OB of the patient phase of the blood loss protocol, notifying the blood bank of the patient's blood type), preparations (e.g., preparing transfusion equipment), or any suitable combination thereof. In some example embodiments, some or all of the elements are shown in the order in which they should be completed. In some example embodiments, some or all of the elements are arranged based on multiple organizing methods (e.g., arranged into categories and then in the order of expected or indicated completion within each category). However, the elements can generally be arranged on the display in any suitable manner.

[0079] In some example embodiments, additionally or alternatively, providing guidance includes providing guidance by way of one or more audio cues, haptic cues, or any suitable combination thereof. For example, the guidance (e.g., elements selected from one or more of the current patient stage) may be recited or otherwise output from a speaker device. As another example, one or more haptic cues (e.g., vibrations from a vibration motor with or without a flashing light from a mobile computing device or other device) may be associated with one or more elements of the guidance (e.g., color-coded to a particular recommended action or category of actions). Providing guidance to the user may also include providing an indication when the guidance is updated. In some example embodiments, an audio or visual cue may indicate that updated guidance has been provided. This may provide the benefit of warning the user that a change has been made to the displayed elements. As discussed above, this may be in response to an input (e.g., a manual or automated user input indicating the occurrence of an action or event), an updated patient blood loss stage (e.g., based on an updated estimated patient blood loss), or both. Thus, a notification may be provided when the guidance is updated based on a user input (e.g., as a result thereof), an updated patient stage, or both. Any suitable notification may be used to notify the user of the updated guidance, such as a sound (e.g., a ringtone, beep, buzzer, hum, or any suitable combination thereof), vibration, flash, color change, a dynamic visual showing an element being swapped out, or some or all of the blood loss protocol being scrolled, any suitable combination thereof, or any other suitable cue. In other words, one or more alerts or notifications may be provided to prompt the user to view the guidance (e.g., output a beep or buzzer to draw the user's attention to the display providing the guidance).

[0080] Displaying guidance to a user can include displaying guidance that consists of one or more elements selected from the current patient stage. However, the display of guidance can also include displaying one or more elements from additional patient stages. For example, displaying guidance to a user can include displaying guidance from a previous patient stage, such as if there are one or more elements that the user did not complete in the previous patient stage but that should still be completed. Additionally, providing guidance can include providing one or more notifications that the user has not performed an element. Such notifications can be presented visually, such as on a display screen of a computerized device (e.g., flashing, blinking, changing the color of an item, or any suitable combination thereof), via one or more audio cues (e.g., by providing a noise or a verbal cue to indicate that an element has not been completed), via one or more tactile cues (e.g., by causing vibration from a vibration motor in a mobile device), or any suitable combination thereof. In some example embodiments, the providing and display of guidance can include presenting one or more elements from a subsequent patient stage. For example, if the estimated patient blood loss is increasing and the patient is about to enter the next severe patient stage, then the processor can start “queuing” one or more additional elements from the subsequent patient stage in anticipation of the patient's deteriorating condition. In some example embodiments, one or more elements from a subsequent stage can be presented together with one or more elements from the current patient stage. Elements from a subsequent patient stage can be distinguished from elements from the current patient stage. For example, elements from a subsequent stage can be a different color, a different intensity, or can be separated by a line or a marker to distinguish elements from different stages. For example, Figure 7 An example GUI for display is depicted, showing elements from stages 2 and 3 of a blood loss protocol. Elements from patient stage 2 appear below a header labeled “STAGE 2” at the top of the screen, and elements from patient stage 3 appear below a “STAGE3” header at the bottom of the screen and are separated from the stage 2 elements by a dashed line.

[0081] Providing guidance to a user can include displaying one or more summary graphics of the patient's current blood loss that are related to the patient stage of a blood loss protocol, such as a chart or a progress bar. Figure 8An example of a summary graph showing a patient's blood loss is shown. The summary graph includes a status bar 710 having four patient stages of blood loss, indicated by a change in shading or coloring (e.g., grayscale intensity) from left to right. The current patient blood loss stage associated with the four patient stages is indicated by a marker icon 720 such as a triangle. The current patient stage along with the estimated blood loss is also indicated on the display. The summary graph can show how many elements or steps in the blood loss protocol associated with each stage have been completed by the user, relative to the total number of steps presented to the user. That is, each section of the status bar (e.g., each section is associated with a different patient stage) can have fractions 730, 732 near it (e.g., below), indicating the number of steps completed relative to the number of steps presented. For example, in Figure 7 In the example summary graph shown, the first patient stage of blood loss is marked with fraction 730, indicating that 23 out of 25 steps have been completed for this patient stage. As another example, the second patient stage of blood loss is marked with fraction 732, indicating that 11 out of 11 steps have been completed for this patient stage. Various information (e.g., current patient stage, position of the marker icon, steps completed, etc.) can be updated throughout the medical procedure. Figure 8 An example of the summary graph is shown, but any suitable graph (such as a chart, graph, flowchart, table, or any suitable combination thereof) can be used to summarize information related to the patient's blood loss and track progress in accordance with the blood loss protocol. Additionally, any type of information can be displayed, including the current patient blood loss, the current patient stage of the blood loss protocol, the number of elements completed in each stage, the number of elements not completed in each stage, the length of the procedure, the estimated length of time before the patient reaches the next stage, the length of time the patient spends in each stage, patient data (such as patient vital signs (e.g., heart rate, oxygen level, temperature, etc.)), any other suitable information, or any suitable combination thereof. For example, Figure 13 An example GUI display 1200 is shown, which provides a breakdown of the current patient stage 1210, the estimated cumulative blood loss of the patient 1220, and the source 1230 of the cumulative blood loss estimate (e.g., previously estimated blood loss, blood loss from a container (such as a V - drape), estimated blood loss from a weighed item, etc.). Figure 13 The example GUI in

[0082] Example of data storage and access

[0083] Providing guidance to a user can involve one or more of various methods of accessing and storing data. As described above, one or more bleeding protocols can be stored in the memory of one or more devices. To provide guidance to the user, one or more processors can access the one or more bleeding protocols stored in the memory. As described above, providing guidance to the user can include selecting one or more elements from the bleeding protocol and providing those one or more elements to the user. In some cases, it may be desirable to track and record information about the one or more elements selected from the bleeding protocol and presented to the user. Accordingly, one or more of the methods discussed herein can include creating a data record of the one or more elements provided to the user during a medical procedure. Additionally, as previously described, guiding the user during a medical procedure can include receiving an input indicating whether a particular element has been completed. For example, an element provided to the user can be a recommendation for the user to administer an IV to a patient. When the user completes this element, the processor can receive an indication that the element has been completed. The indication can be an automatically transmitted indication (e.g., a wireless communication from an IV system indicating that it has been properly filled and connected to the patient), or the indication can be in the form of a user input (e.g., the user operates a computerized device to indicate the completion of that particular element). In some example embodiments, the data record can store information about whether one or more of the elements provided to the user (e.g., items of guidance) have been completed. In some example embodiments, determining that an element is not completed can include comparing the one or more elements provided to the user with an indication of the corresponding one or more actions being completed by the user. In some implementations, it can also be useful to track and store information about each element, such as: the time an element was completed or ignored; the time the element was provided, including the medical procedure during which the element was provided; the hospital where the medical procedure was performed (e.g., carried out); the doctor, nurse, or other medical staff involved in the medical procedure; the identity of the user who completed the item; any other relevant information; or any suitable combination thereof. Accordingly, in addition to whether an element is completed, the data record can include any suitable type of information about each element provided to the user.

[0084] Storing and accessing information about guidance provided during a medical procedure can include creating and maintaining a data record having information about the one or more elements provided to the user during the procedure. Figure 9 is a schematic diagram of an example data record for storing information about a procedure. Each box in the data record contains information associated with an element of the procedure. Each row contains information about one element, and each column represents different information about that element. In Figure 9In it, the first column of the example data record contains an element descriptor, which is an indication of what the element is (e.g., an action recommended to the user). In some example embodiments, the data record may store the element descriptor according to what is shown to the user (e.g., the element description may be "perform a blood transfusion"). In other example embodiments, the data record may store the element descriptor according to an element number, element code, or abbreviation. For example, the instruction "perform a blood transfusion" may be stored in the data record as "TRNSF", or any suitable abbreviation, including a numeric code. In some example embodiments, a lookup table may be associated with the data record to indicate the full text for each element code or abbreviation. Figure 9 The second column in the example data record shown in is a status indicator for the element, which indicates whether the element has been completed. Figure 9 The third column in the data record shown in is a timestamp (e.g., showing time, date, or both), indicating the time when the element status was received (e.g., when the element was completed or ignored). However, in other example embodiments, the timestamp may additionally or alternatively be associated with the time when the element was provided to the user (e.g., as an instruction). Figure 9 The fourth column in the data record of is the current patient stage of the blood loss protocol (e.g., the patient stage of the blood loss protocol associated with the patient's blood loss amount when the element was provided, or when the element was completed or ignored). Although Figure 9 it includes four marked columns, the data record may include any suitable number of rows N and any suitable number of columns n to store various amounts of information associated with the elements of the blood loss protocol. Non-limiting examples of such information that may be stored in the data record include: one or more element descriptors, one or more status indicators (e.g., completed or ignored), one or more timestamps of the status (e.g., "time / date"), one or more timestamps shown to one or more users, elapsed time of a medical procedure, the current patient stage of the blood loss protocol, one or more patient parameters (e.g., height, weight, gender, BMI, medical history, etc.), procedure information, hospital information, the user who completed or ignored one or more elements, an estimated patient blood loss amount, an indication of the patient's risk of bleeding or other complications, an estimate of the time when the patient will reach an unacceptable blood loss level, any other suitable information, or any suitable combination thereof.

[0085] Data records generated during a medical procedure can be used for various purposes, such as during the medical procedure, after the medical procedure is completed, or both. During the medical procedure, the data record can be accessed by one or more processors to obtain information about which elements have been provided to the user, as well as any other relevant information about the provided elements (e.g., status, time, phase, etc.). For example, as described above, certain elements of a blood loss protocol can be conditionally selectable. Thus, providing guidance to the user can include accessing the data record during the medical procedure to determine whether a conditionally selectable element is currently selectable for providing to the user as guidance. The data record can be used to provide an indication to the user about which elements have been completed. For example, when displaying one or more indications that indicate whether the user has completed an element, the processor can access the data record to determine, confirm, or both whether the element has been completed to correspondingly determine whether an indication that the element has been completed should be displayed. In addition, information from the data record can be used to transmit information during the medical procedure. For example, providing guidance can include providing information to hospital administrators when an element provided to the user is ignored. Thus, the data record can be accessed to notify the administrator of the ignored element. Information from the data record can also be used to determine whether usage complies with the provided guidance, as discussed below.

[0086] It can be expected to access the data record after the medical procedure is completed. At the end of the medical procedure, the data record represents a partial or complete sequence of events of the medical procedure. Thus, the data record can be used in various ways to provide information about the medical procedure. For example, the data record can be stored and associated with the patient's electronic medical record. As another example, hospital administrators can use the data record to determine compliance with a blood loss protocol, which provides one or more elements to one or more users. This information can be used to determine whether a particular user needs to improve compliance with the prescribed protocol. The data record can be used to analyze the impact of certain actions on patient outcomes. For example, information from the data record can be used to refine the content of the blood loss protocol (e.g., add elements, delete elements, rearrange elements, rewrite elements, change the nature of conditionally selectable or conditionally non-selectable elements, or otherwise revise one or more elements of the blood loss protocol) in an effort to improve patient outcomes. Information from the data record can be transmitted in any suitable manner. In some example embodiments, the data record can be exported, sent in an email, saved to a server, printed, uploaded, or saved to a cloud-based storage system, or any suitable combination thereof. The data record can be stored in any suitable format. In some example embodiments, storing information from the data record includes formatting the information as a chart, spreadsheet, list, or any suitable combination thereof. In other example embodiments, the storage and transmission of such information can include generating charts or graphs based on the data in the data record. Additionally, the raw data in the data record can be exported and / or manipulated in any suitable manner by any suitable program.

[0087] Other example variations

[0088] One or more of the methods discussed herein can include providing guidance during a medical procedure based on one or more other suitable types of medical parameter protocols. For example, such methods can include estimating a patient's medical parameters and using the estimated medical parameters to inform the guidance provided to the user. In some example embodiments, such as in Figure 15In the method depicted, the method 1400 of providing guidance to a user may include estimating 1410 a patient's medical parameters, determining 1420 a current patient stage of a medical parameter protocol based on the estimated medical parameters, and providing 1430 guidance to the user at least in part based on the current patient stage. Generally, method 1400 may be similar to one or more of the methods of providing guidance based on a blood loss protocol described above, except that in method 1400 the guidance may additionally or alternatively be associated with one or more other medical parameters. For example, providing such guidance based on one or more medical parameter protocols may help ensure rapid and accurate compliance with one or more best practices, one or more other protocols for patient medical care (e.g., administration of medications, other actions), or any suitable combination thereof, thereby improving patient outcomes.

[0089] Examples of such medical parameters include: blood loss, blood pressure, hematocrit, hemoglobin concentration, concentration of another blood component, heart rate, coagulation (e.g., characterized by TEG), temperature, oxygen saturation, height, weight, age, BMI, gender, body fat percentage, intravenous fluid delivered, or any suitable combination thereof. One or more of these medical parameters may be estimated using one or more of the methods described herein (e.g., estimated blood loss or estimated blood component concentration), suitable instruments (e.g., sphygmomanometer, scale, pulse oximeter, thermometer, flow meter coupled to a TN setting, etc.), or any suitable combination thereof.

[0090] A medical parameter protocol may include, for example, multiple patient stages based on at least one estimated medical parameter, and each patient stage may include one or more elements. In some example embodiments, one or more of the elements of a patient stage may include one or more recommended actions to be performed by the user to manage the patient's health characteristics (e.g., restoring the medical parameter to an acceptable or normal range). In some example embodiments, the determination of the current patient stage may involve comparing the estimated medical parameters to one or more ranges of medical parameter values. Each range may be associated with a corresponding patient stage of the medical parameter protocol. Thus, the estimated medical parameters for a patient may be associated with a corresponding patient stage of the medical parameter protocol to determine the current patient stage, e.g., by comparing the estimated medical parameters to ranges of medical parameter values associated with one or more of the various stages of the medical parameter protocol.

[0091] In addition, in some example embodiments, multiple estimated medical parameters are used individually or in a suitable combination to determine the current patient stage in a medical parameter protocol. For example, if a patient has a high heart rate (e.g., greater than 120 bpm) and a high systolic blood pressure (e.g., greater than 160 mmHg) at a given age (e.g., greater than 70 years), then a method for providing guidance to a user can include determining the current patient stage of the patient based on a combination of these medical parameters. For example, the current patient stage can be determined by comparing each medical parameter with a range of medical parameter values associated with respective patient stages of the medical parameter protocol.

[0092] Then, the method can include providing guidance (e.g., a series of protocol instructions specific to or associated with the current patient stage based on such a combination of medical parameters), which can include, for example, administering certain amounts and quantities of medications to manage the patient's return to a normal medical range. Guidance specific to a value or range of values of a medical parameter can be provided based on protocol instructions for the associated condition. Providing such guidance can involve selecting one or more elements from the current patient stage of the medical parameter protocol. The providing of guidance can also include displaying the guidance (e.g., composed of the selected elements) to the user via a display screen (e.g., the display screen of a mobile computing device), or providing the guidance in any suitable manner (e.g., other notifications, such as other visual notifications, audio notifications, tactile notifications, etc.).

[0093] Overview of an example system

[0094] The example systems described herein implement one or more of the example methods for providing guidance to a user discussed herein. Such systems for providing guidance to a user can include one or more processors configured to estimate a patient's blood loss, determine the current patient stage of a blood loss protocol based on the estimated blood loss, and provide guidance to the user based on the current patient stage of the blood loss protocol. As described above, one or more processors of such a system for providing guidance to a user can be configured to select one or more elements from the current patient stage of the blood loss protocol. Additionally, the one or more processors can also be configured to provide updated guidance to the user based on user input, an updated patient stage of the blood loss protocol, or both. Such a system can include a display configured to display information to the user. Similarly, such a system for providing guidance to a user can include one or more processors configured to estimate a patient's medical parameters, determine the current patient stage of a medical parameter protocol based on the estimated medical parameters, and provide guidance to the user based on the current patient stage of the medical parameter protocol.

[0095] As Figure 10As shown, a system 900 for guiding a user during a medical procedure may include at least one processor 910 and a memory 920 for storing instructions to be executed by the processor 910, data generated during the medical procedure, or both. In some example embodiments, the instructions to be executed by the processor 910 may relate to using one or more blood loss protocols or one or more other medical parameter protocols, which are also stored in the memory 920. For example, the system 900 may include one or more processors 910 configured to execute one or more aspects of the methods described herein as part of a mobile application executable on a mobile computing device. As described above, a blood loss protocol may include one or more patient stages, each stage associated with one or more ranges of blood loss values, and each patient stage may include one or more elements. Similarly, a medical parameter protocol may include one or more patient stages, each patient stage associated with one or more ranges of medical parameter values, and each patient stage may include one or more elements. Generally, the system 900 may be configured to substantially execute one or more of the methods described in further detail above. As Figure 10 As further shown, the system 900 may include a camera 930 for obtaining one or more images, and the system 900 may include a display 940 for displaying guidance or other information to the user. In some example embodiments, some or all of the system 900 may be in an integrated device and placed near the patient, the user, or both during the medical procedure (e.g., in an operating room) to guide the user during the medical procedure. For example, the system 900 may at least partially include a handheld or mobile electronic computing device. Such a handheld or mobile device may be, for example, a tablet computer, a laptop computer, a mobile smart phone, or any suitable combination thereof, and such a device may include a camera (e.g., camera 930), a processor (e.g., processor 910), and a display (e.g., display 940). However, in other example embodiments, some or all of the system components may be separated into discrete, interconnected devices. For example, during the medical procedure (e.g., in an operating room), the camera 930, the display 940, or both may be located substantially near the patient, the user, or both, while the processor 910 may be located at a remote location (e.g., separate from the camera, the display, or both within the operating room, or outside the operating room), communicating with the camera 930 and the display 940 via a wired or wireless connection or other network.

[0096] Generally, one or more processors 910 may be configured to execute instructions stored in a memory 920 such that when the one or more processors 910 execute the instructions, the one or more processors 910 perform one or more aspects (e.g., operations) of the methods described herein. The instructions may be executed by computer-executable components integrated with hardware / firmware / software elements of an application, applet, host, server, network, website, communication service, communication interface, user computer or mobile device, wristband, smart phone, or any suitable combination thereof. The instructions may be stored in a memory or other computer-readable medium such as RAM, ROM, flash memory, EEPROM, optical devices (e.g., CD or DVD), hard disk drive, floppy disk drive, or any suitable device).

[0097] As described above, one or more processors 910 may be integrated into a handheld or mobile device. In other example embodiments, one or more processors 910 may be incorporated into a computing device or system such as a cloud-based computer system, mainframe computer system, grid computer system, or other suitable computer system. Additionally or alternatively, one or more processors 910 may be incorporated into a remote server that receives information regarding an estimated patient blood loss, compares the estimated patient blood loss to a threshold defining a range associated with a patient phase of a blood loss protocol to determine a current patient phase, and selects an element from the current patient phase to provide guidance to a user.

[0098] One or more of the example systems discussed herein (e.g., system 900) may include a camera 930 (e.g., an optical sensor) for generating one or more images, such as a collection of one or more still images or as part of a video source. As described above, one or more images may be used to estimate a patient's blood loss. The camera 930 may include at least one optical image sensor (e.g., CCD, CMOS, etc.) that captures a color optical digital image having red, green, and blue (RGB) color components for pixels, other suitable optical components, or any suitable combination thereof. For example, the camera 930 may include a single image sensor paired with one or more suitable corresponding optics, one or more filters (e.g., one or more color filter arrays, such as a Bayer pattern filter), or any suitable combination thereof. As another example, the camera 930 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 color channel being detected by a corresponding image sensor. However, the camera 930 may include any suitable image sensor or other optical component to enable the camera 930 to generate images. The camera 930 may be configured to generate any number or type of suitable images, such as images depicting a fluid matrix, such as a fluid container (e.g., a tank), surgical items (e.g., surgical fabrics), or any suitable combination thereof.

[0099] The camera 930 may be configured to transmit the images to the processor 910 for analysis, to a database that stores the images, or to both. As previously described, the camera 930 may be integrated with one or more other components of the system 900 in the same device, or the camera may be a separate component that transmits image data to the other components.

[0100] One or more of the example systems discussed herein (e.g., system 900) may include a display 940 that functions to display or otherwise communicate guidance or other information to a user (e.g., a doctor, a nurse, etc.). And such information may be generated by the system 900, including one or more elements of a patient stage of a blood loss protocol (e.g., actions to be performed by the user), patient information, an estimated blood loss of the patient, the current patient stage of the blood loss protocol, one or more notifications, a summary graph of the blood loss protocol and the patient's blood loss, one or more images of a surgical fabric, one or more quantified metrics characterizing the fluid in the surgical fabric, or any suitable combination thereof. The display 940 may include a screen on a handheld or mobile device, a computer monitor, a television screen, a projector screen, or other suitable display.

[0101] In some example embodiments, the display 940 is configured to display a user interface (e.g., a GUI) that enables a user to interact with the displayed information. For example, the user interface may enable the user to provide an indication of elements of the blood loss protocol that the user has completed; provide information about the patient, the procedure, the hospital, etc.; manipulate an image of the fluid matrix (e.g., zoom, crop, rotate, etc.); or any suitable combination thereof. As another example, the user interface may enable the user to select one or more display options (e.g., font, color, language, etc.), various content (e.g., patient information, quantified metrics or other fluid-related information, information about the current patient stage of the blood loss protocol, alerts, etc.), or any suitable combination thereof. In such example embodiments, the display 940 may be user-interactive and include a resistive or capacitive touchscreen responsive to skin, a probe, or other user contact. In other example embodiments, the display 940 may be user-interactive via a cursor controlled by a mouse, keyboard, or other input device.

[0102] In some example embodiments, the system 900 may additionally or alternatively include an audio system for communicating information to the user. The display 940, the audio system, or both may provide the user with current audio cues or other notifications, which may assist the user in performing elements of the blood loss protocol or other medical parameter protocols.

[0103] As Figure 10 shown, the display 940 may be integrated with one or more components of the system 900 in the same device. Additionally or alternatively, the display 940 may include a separate stand-alone monitor, screen, or other suitable display.

[0104] In some example embodiments, one or more of the systems discussed herein (e.g., the system 900) may also include items useful for tracking and quantifying a patient's blood loss, such as a matrix configured to contain a fluid such as blood. For example, such systems may include fluid tanks, surgical items such as surgical fabrics, or any suitable combination thereof. Such systems may also include one or more items configured to detect or otherwise determine the weight of an object, such as a scale. Additionally, such systems may include a bracket or mount configured to hold a mobile device on which instructions are to be displayed.

[0105] In addition, such systems can include one or more articles configured to estimate one or more other medical parameters, such as medical parameters for managing patient care based on a medical parameter protocol. For example, one or more instruments for measuring blood pressure, hematocrit, hemoglobin concentration, concentration of another blood component, heart rate, coagulation (e.g., characterized by TEG), temperature, oxygen saturation, height, weight, age, BMI, gender, body fat percentage, intravenous infusion, etc. or any suitable combination thereof. Such instruments can include, for example, sphygmomanometers, scales, pulse oximeters, thermometers, flow meters coupled to IV setups, etc.

[0106] For purposes of explanation, the above description uses specific nomenclature to provide a thorough understanding of the subject matter. However, it will be apparent to those skilled in the art that no specific details are required to practice the subject matter. Accordingly, the foregoing description of specific embodiments of the subject matter is presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the subject matter to the precise forms disclosed. Given the above teachings, many modifications and variations are possible. The example embodiments are chosen and described to explain the principles of the subject matter and its practical application. Thereby, these example embodiments enable other technicians in the art to utilize the subject matter and various example embodiments with various modifications suitable for the particular purposes contemplated.

[0107] The following enumerated description describes various examples of the methods, machine-readable media, and systems (e.g., machines, devices, or other apparatuses) discussed herein.

[0108] A first example provides a method for providing guidance during a medical procedure, the method comprising:

[0109] at one or more processors:

[0110] estimating the blood loss of a patient;

[0111] determining a current patient stage of a blood loss protocol based on the estimated blood loss; and

[0112] providing guidance for a user based on the current patient stage of the blood loss protocol.

[0113] A second example provides the method according to the first example, wherein estimating the blood loss includes evaluating color parameters in an image depicting a fluid-containing matrix.

[0114] A third example provides the method according to the second example, wherein estimating the blood loss includes comparing color parameters of at least a portion of the image to a template image to determine a blood component concentration associated with at least a portion of the fluid-containing matrix.

[0115] The fourth example provides a method according to the second or third example, wherein estimating blood loss includes using parametric equations to determine blood component concentrations based on color parameters.

[0116] The fifth example provides a method according to any one of the second to fourth examples, wherein the substrate is a fluid container.

[0117] The sixth example provides a method according to any one of the second to fifth examples, wherein the substrate is a surgical fabric.

[0118] The seventh example provides a method according to any one of the second to sixth examples, wherein estimating the patient's blood loss includes detecting the weight of the fluid-containing substrate.

[0119] The eighth example provides a method according to the seventh example, wherein the substrate is a surgical fabric.

[0120] The ninth example provides a method according to the seventh example, wherein the substrate is a fluid container.

[0121] The tenth example provides a method according to any one of the first to ninth examples, wherein the blood loss protocol is a predefined protocol for managing bleeding risk.

[0122] The eleventh example provides a method according to any one of the first to tenth examples, wherein the blood loss protocol is stored in one or more memory devices.

[0123] The twelfth example provides a method according to any one of the first to thirteenth examples, wherein the blood loss protocol is customizable based on one or more user settings.

[0124] The thirteenth example provides a method according to the twelfth example, wherein the one or more user settings include one or more threshold blood loss values associated with each patient stage of the blood loss protocol.

[0125] The fourteenth example provides a method according to any one of the first to thirteenth examples, wherein determining the current patient stage includes comparing the estimated patient blood loss with one or more threshold blood loss values.

[0126] The fifteenth example provides a method according to the fourteenth example, wherein the blood loss protocol includes multiple patient stages, and wherein at least one patient stage is associated with a lower threshold blood loss value and an upper threshold blood loss value.

[0127] The sixteenth example provides a method according to any one of the first to fifteenth examples, wherein the blood loss protocol includes multiple patient stages, wherein each patient stage includes one or more elements.

[0128] The seventeenth example provides a method according to the sixteenth example, wherein the one or more elements include recommended actions.

[0129] The eighteenth example provides a method according to the seventeenth example, wherein providing guidance to the user includes selecting one or more elements from the current patient stage of the blood loss protocol.

[0130] The nineteenth example provides a method according to the eighteenth example, wherein providing guidance further includes displaying on a display the one or more elements selected from the current patient stage of the protocol.

[0131] The twentieth example provides a method according to the nineteenth example, wherein the display is on a mobile device.

[0132] The twenty - first example provides a method according to any one of the first to twentieth examples, wherein providing guidance to the user is further based on user input.

[0133] The twenty - second example provides a method according to any one of the first to twenty - first examples, further including providing updated guidance to the user.

[0134] The twenty - third example provides a method according to the twenty - second example, wherein the updated guidance is based on at least one user input.

[0135] The twenty - fourth example provides a method according to the twenty - third example, wherein the blood loss protocol includes a plurality of patient stages, and each patient stage includes one or more elements, and wherein providing the updated guidance includes selecting one or more elements from the current patient stage of the protocol based on the at least one user input.

[0136] The twenty - fifth example provides a method according to the twenty - fourth example, wherein at least one element can be conditionally selected by the one or more processors to provide the updated guidance.

[0137] The twenty - sixth example provides a method according to the twenty - fifth example, wherein the at least one conditionally selectable element is conditionally selectable based on the at least one user input.

[0138] The twenty - seventh example provides a method according to the twenty - sixth example, wherein the at least one user input includes an indication that the user performs one or more elements of the blood loss protocol.

[0139] The twenty - eighth example provides a method according to any one of the twenty - second to twenty - seventh examples, further including determining an updated patient stage based on an updated blood loss estimate.

[0140] The twenty - ninth example provides a method according to the twenty - eighth example, wherein providing the updated guidance to the user is based on the updated patient stage.

[0141] The thirtieth example provides a method according to the twenty-ninth example, wherein providing the updated guidance is further based on at least one user input.

[0142] The thirty-first example provides a method according to any one of the twenty-second to thirtieth examples, wherein providing the updated guidance further includes displaying the updated guidance on a display.

[0143] The thirty-second example provides a method according to any one of the first to thirty-first examples, further including displaying a notification associated with the current patient stage of the blood loss protocol on a display.

[0144] The thirty-third example provides a system for providing guidance during a medical procedure, the system including:

[0145] One or more processors configured to:

[0146] Estimate the patient's blood loss;

[0147] Determine the current patient stage of the blood loss protocol based on the estimated blood loss; and

[0148] Provide guidance to the user based on the current patient stage of the blood loss protocol.

[0149] The thirty-fourth example provides a system according to the thirty-third example, wherein the blood loss protocol includes a plurality of patient stages, and wherein each patient stage includes one or more elements.

[0150] The thirty-fifth example provides a system according to the thirty-fourth example, wherein providing guidance to the user includes selecting one or more elements from the current patient stage of the blood loss protocol.

[0151] The thirty-sixth example provides a system according to any one of the thirty-third to thirty-fifth examples, wherein the one or more processors are further configured to provide updated guidance to the user.

[0152] The thirty-seventh example provides a system according to the thirty-sixth example, wherein the updated guidance is based on user input.

[0153] The thirty-eighth example provides a system according to the thirty-sixth example or the thirty-seventh example, wherein the one or more processors are further configured to estimate the patient's updated blood loss and determine an updated patient stage based on the updated estimated blood loss.

[0154] The thirty-ninth example provides a system according to the thirty-eighth example, wherein the updated guidance is based on the updated patient stage.

[0155] The fortieth example provides a system according to any one of the thirty-third to thirty-ninth examples, further including a display configured to display the guidance to the user.

[0156] Example 41 provides a method for providing guidance during a medical procedure, the method comprising:

[0157] at one or more processors:

[0158] estimating a medical parameter of a patient;

[0159] determining a current patient stage of a medical parameter protocol based on the estimated medical parameter; and

[0160] providing guidance to a user based on the current patient stage of the medical parameter protocol.

[0161] Example 42 provides the method according to Example 41, wherein the medical parameter is at least one medical parameter selected from the following: blood loss, blood pressure, hematocrit, blood component concentration, heart rate, coagulation, temperature, oxygen saturation, height, weight, age, body mass index, gender, body fat percentage, and intravenous infusion.

[0162] Example 43 provides a system for providing guidance during a medical procedure, the system comprising:

[0163] one or more processors configured to:

[0164] estimate a medical parameter of a patient;

[0165] determine a current patient stage of a medical parameter protocol based on the estimated medical parameter; and

[0166] provide guidance to a user based on the current patient stage of the medical parameter protocol.

[0167] Example 44 provides the system according to Example 43, wherein the medical parameter is at least one medical parameter selected from the following: blood loss, blood pressure, hematocrit, blood component concentration, heart rate, coagulation, temperature, oxygen saturation, height, weight, age, body mass index, gender, body fat percentage, and intravenous infusion.

[0168] Example 45 provides a carrier medium carrying machine-readable instructions for controlling a machine to perform the operations (e.g., method operations) performed in any of the foregoing examples.

[0169] Example 46 provides a machine-readable medium (e.g., a non-transitory machine-readable storage medium) comprising instructions that, when executed by one or more processors of a machine, cause the machine to perform the operations specified in any of the foregoing examples (e.g., method operations).

[0170] Priority protection

[0171] This application claims priority to U.S. Provisional Patent Application No. 62 / 870,608, filed on July 3, 2019, entitled "SYSTEMS AND METHODS FOR PROVIDING GUIDANCE DURING A MEDICAL PROCEDURE", which is incorporated herein by reference in its entirety.

Claims

1. A method, comprising: Estimate, by one or more processors of a machine, the amount of blood lost by a patient during a procedure; Determine, by the one or more processors of the machine, a current stage among a plurality of stages of a blood loss protocol, the current stage of the blood loss protocol being determined based on the estimated amount of blood lost by the patient during the procedure; And Cause, by the one or more processors of the machine, a display to present guidance to a user based on the current stage determined among the plurality of stages of the blood loss protocol.

2. The method according to claim 1, wherein: The current stage of the blood loss protocol corresponds to a set of recommendable actions that can be performed on the patient; and The presentation of the guidance recommends performing an action among the set of recommendable actions.

3. The method according to claim 1, wherein: The determination of the current stage of the blood loss protocol is based on a comparison of the estimated amount of blood lost by the patient with a blood loss value range that corresponds to the current stage of the blood loss protocol.

4. The method according to claim 3, wherein: A plurality of ranges of blood loss values correspond to the current stage of the blood loss protocol; and The determination of the current stage of the blood loss protocol includes selecting, based on medical parameters of the patient, a range corresponding to the current stage of the blood loss protocol.

5. The method according to claim 3, wherein: A plurality of ranges of blood loss values correspond to the current stage of the blood loss protocol; and The determination of the current stage of the blood loss protocol includes selecting, based on user input, a range corresponding to the current stage of the blood loss protocol.

6. The method according to claim 1, wherein: The presentation of the guidance indicates the current stage of the determined blood loss protocol.

7. The method according to claim 1, wherein: The current stage of the blood loss protocol corresponds to a set of recommendable actions that can be performed on the patient; and The presentation of the guidance indicates a recommended action selected from among the set of recommendable actions that can be performed on the patient.

8. The method according to claim 1, wherein: The estimation of the amount of blood lost by the patient includes updating a previous estimate of the amount of blood lost by the patient; The determination of the current stage of the blood loss protocol includes updating a previous determination of the current stage of the blood loss protocol based on the updated estimate of the amount of blood lost by the patient; and The presentation of the guidance presents updated guidance based on the updated determination of the current stage of the blood loss protocol.

9. A system, comprising: A display; One or more processors; And A memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations including the following: Estimate the amount of blood lost by a patient during a procedure; Determine a current stage among a plurality of stages of a blood loss protocol, the current stage of the blood loss protocol being determined based on the estimated amount of blood lost by the patient during the procedure; And Cause a display to present guidance to a user based on the current stage determined among the plurality of stages of the blood loss protocol.

10. The system according to claim 9, wherein: The current stage of the blood loss protocol corresponds to a set of recommendable actions that can be performed on the patient; and The presentation of the guidance recommends performing an action among the set of recommendable actions.

11. The system according to claim 9, wherein: The determination of the current stage of the blood loss protocol is based on a comparison of the estimated amount of blood lost by the patient with a blood loss value range that corresponds to the current stage of the blood loss protocol.

12. The system according to claim 11, wherein: A plurality of ranges of blood loss values correspond to the current stage of the blood loss protocol; and The determination of the current stage of the blood loss protocol includes selecting, based on medical parameters of the patient, a range corresponding to the current stage of the blood loss protocol.

13. The system according to claim 11, wherein: A plurality of ranges of blood loss values correspond to the current stage of the blood loss protocol; and The determination of the current stage of the blood loss protocol includes selecting, based on user input, a range corresponding to the current stage of the blood loss protocol.

14. The system according to claim 9, wherein: The guidance presents an indication of the current stage of the blood loss protocol determined by the presentation indication.

15. The system according to claim 9, wherein: The current stage of the blood loss protocol corresponds to a set of recommended actions that can be performed on the patient; and The guidance presents a recommended action selected from the set of recommended actions that can be performed on the patient.

16. The system according to claim 9, wherein: The estimation of the amount of blood lost by the patient includes updating a previous estimation of the amount of blood lost by the patient; The determination of the current stage of the blood loss protocol includes updating a previous determination of the current stage of the blood loss protocol based on the updated estimation of the amount of blood lost by the patient; and The guidance presented presents guidance updated based on the updated determination of the current stage of the blood loss protocol.

17. A machine-readable medium comprising instructions that, when executed by one or more processors of a machine, cause the machine to perform operations including: estimating the amount of blood lost by a patient during a procedure; Determining the current stage among multiple stages of a blood loss protocol, the current stage of the blood loss protocol being determined based on the estimated amount of blood lost by the patient during a procedure; and Based on the current stage determined among the multiple stages of the blood loss protocol, causing a display to present guidance to a user.

18. The machine-readable medium according to claim 17, wherein: The current stage of the blood loss protocol corresponds to a set of recommended actions that can be performed on the patient; and The guidance presented recommends performing an action among the set of recommended actions.

19. The machine-readable medium according to claim 17, wherein: The determination of the current stage of the blood loss protocol is based on a comparison of the estimated amount of blood lost by the patient with a range of blood loss values that corresponds to the current stage of the blood loss protocol.

20. The machine-readable medium according to claim 19, wherein: Multiple ranges of blood loss values correspond to the current stage of the blood loss protocol; and The determination of the current stage of the blood loss protocol includes selecting a range corresponding to the current stage of the blood loss protocol based on medical parameters of the patient.

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