Providing guidance in medical procedures

Abstract

Described herein are example methods and example systems for providing guidance to a user during a medical procedure. The example methods may be performed by one or more processors and may include estimating a patient's blood loss, determining a current patient phase of a blood loss protocol based on the estimated patient blood loss, and providing guidance to a user based on the current patient phase of the blood loss protocol. The blood loss protocol may include multiple phases, and each phase may include one or more elements. Providing guidance to a user may include selecting one or more elements from the current patient phase of the blood loss protocol.

Description

[0001] Priority protection

[0002] 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. Technical Field

[0003] The subject matter disclosed herein relates generally 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 special-purpose machines that facilitate providing guidance during medical procedures, including computerized variations of software configurations of such special-purpose machines and improvements to such variations, as well as improvements to the technology that improves such special-purpose machines over other special-purpose machines that facilitate providing guidance in medical procedures. Background Art

[0004] Effectively managing and responding to patient blood loss during medical procedures helps avoid complications. However, effective management and response to patient blood loss involves various challenges, such as inaccurate reporting of patient blood loss and misapplication of best practice procedures for blood loss management. For example, doctors and other medical personnel often visually estimate a patient's blood loss. This leads to significant errors, which can lead to mischaracterization of the severity of a patient's bleeding risk, and the resulting failure to perform steps to effectively manage patient blood loss and prevent complications resulting therefrom. For example, underestimating a patient's blood loss can lead to delayed resuscitation and transfusion, increased risk of infection, tissue death, or even patient death, such as in a bleeding event. Therefore, it would be beneficial to provide new and improved systems and methods for providing guidance during medical procedures to improve patient outcomes. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 is a schematic block diagram depicting a method for guiding a user (eg, a physician such as a surgeon, or other medical personnel) during a medical procedure, according to some example embodiments.

[0006] Figure 2 is a schematic depiction of a blood loss protocol, according to some example embodiments.

[0007] Figure 3 is a schematic block diagram depicting a method for estimating an amount of a blood component within a matrix, according to some example embodiments.

[0008] Figure 4is a schematic depiction of a blood loss protocol and a method of selecting elements from a blood loss protocol to provide guidance to a user, according to some example embodiments.

[0009] Figure 5 is a schematic block diagram depicting a method for guiding a user during a medical procedure, according to some example embodiments.

[0010] Figure 6 is a depiction of a graphical user interface (GUI) including elements for guiding a user through a blood loss protocol, according to some example embodiments.

[0011] Figure 7 is a depiction of a GUI including elements from multiple patient phases of a blood loss protocol to guide a user, according to some example embodiments.

[0012] Figure 8 is a depiction of a summary graphic that may be displayed to a user (eg, via a GUI) during a medical procedure, according to some example embodiments.

[0013] Fig. 9 is a schematic depiction of a data record for storing and organizing data generated during a medical procedure, according to some example embodiments.

[0014] Fig.10 is a schematic depiction of a system for guiding a user during a medical procedure, according to some example embodiments.

[0015] Fig.11 is a schematic depiction of a blood loss protocol, according to some example embodiments.

[0016] Fig.12 is a depiction of a GUI including elements of a blood loss protocol to guide a user, according to some example embodiments.

[0017] Fig.13 is a depiction of a GUI including summary graphics that may be displayed to a user during a medical procedure, according to some example embodiments.

[0018] Fig.14 is a depiction of a GUI that allows a user to manually input a fluid volume measured using a fluid container, according to some example embodiments.

[0019] Fig.15 is a schematic block diagram depicting a method for guiding a user during a medical procedure, according to some example embodiments. DETAILED DESCRIPTION

[0020] Example methods (e.g., algorithms) facilitate providing guidance during a medical procedure (e.g., during a surgical procedure), and example systems (e.g., a dedicated machine configured by dedicated software) are configured to facilitate providing guidance during a medical procedure. The examples represent possible variations only. Unless otherwise expressly stated, structures (e.g., structural components, such as modules) are optional and may be combined or subdivided, and operations (e.g., in processes, algorithms, or other functions) may vary in order or be combined or subdivided. In the following description, for purposes of explanation, numerous specific details are set forth 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.

[0021] 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 personnel) 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. In general, the example methods discussed herein can include estimating a patient's blood loss (e.g., estimating the amount of blood lost by the patient), 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 a 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, a blood loss protocol can be or include a predetermined protocol for managing bleeding risk (e.g., for patients undergoing a medical procedure, for a general patient, or both). A blood loss protocol (e.g., for managing bleeding risk) can include multiple patient stages, which can be described based on the severity of the patient's blood loss. A blood loss protocol can be stored in one or more memory devices. In some example embodiments, the blood loss protocol may be accessed by one or more processors to provide guidance to the user. Additionally, the blood loss protocol may be customized based on one or more user settings. For example, such user settings may include one or more threshold blood loss values ​​associated with each of a plurality of patient stages of the blood loss protocol. Each of a plurality of patient stages of the blood loss protocol may 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). Thus, determination of the current patient stage may include comparing the estimated blood loss with a threshold associated with one or more patient stages of the blood loss protocol.

[0022] In some example embodiments, the estimation of the amount of blood loss of a patient includes estimating the amount of blood in a matrix containing a fluid, such as a fluid container or a surgical item (such as a fabric). Estimating the amount of fluid in the matrix may include using one or more image analysis techniques. For example, the estimation of the amount of blood loss of a patient may include evaluating color parameters in one or more images depicting a fluid-containing matrix. In some example embodiments, the estimation of the amount of blood loss of a patient includes correlating color parameters with blood component concentrations in a fluid-containing matrix to estimate the amount of blood contained in the matrix. For example, the estimation of the amount of blood loss of a patient may include comparing color parameters of at least a portion of an image with a template image to determine the blood component concentration associated with at least a portion of the fluid-containing matrix. As another example, the estimation of the amount of blood contained in the fluid-containing matrix may include using a parametric equation to determine the blood component concentration based on the color parameters. In some example embodiments, the estimation of the amount of blood loss of a patient includes combining the amount of blood in a plurality of fluid-containing matrices. In some example embodiments, determining the amount of blood loss of a patient includes detecting or determining the weight of a fluid-containing matrix. Weight information may be used instead of or in combination with information obtained from analyzing an image depicting a fluid-containing matrix. 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 the fluid in the fluid-containing matrix. The concentration and volume can be used to determine the patient's blood loss.

[0023] In some example embodiments of the methods and systems described herein for providing guidance to a user during a medical procedure, an estimated amount of blood loss of a patient informs the guidance provided to the user, and the guidance may be based on a blood loss protocol. A blood loss protocol for providing guidance to a 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., starting a blood transfusion, administering an intravenous (IV) infusion, providing a specific medication to a patient, or any suitable combination thereof). Therefore, in some example embodiments, the provision of guidance includes selecting one or more elements from the current patient phase of the blood loss protocol. Guidance may be selected, generated, provided, or any suitable combination thereof based on an estimated amount of blood loss of a patient (e.g., by selecting an element from the current patient phase, which may be determined based on an estimated amount of blood loss of a patient). However, in some example embodiments, 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 that a user has taken, or patient information manually entered by a user) may affect one or more elements selected by a processor to provide guidance to a user. Providing guidance to the user may also involve displaying one or more elements selected from the current patient phase of the protocol or a previous or subsequent patient phase on a display (e.g., a display screen of a mobile computing device such as a laptop, tablet, or smartphone). Additionally or alternatively, guidance may be provided in or in conjunction with other visual notifications (e.g., lights such as LEDs on the device), audio notifications (e.g., through one or more speakers), tactile notifications (e.g., vibrations, etc.), or any suitable combination thereof.

[0024] 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 amount of blood loss of the patient). The guidance to be provided may be updated in any suitable manner. For example, providing guidance may include estimating an updated amount of blood loss of the patient (e.g., updating the estimated amount of blood loss of the patient), and determining an updated patient stage based on the updated estimated amount of blood loss of the patient. Thus, updated guidance may be provided based on the updated patient stage. In some example embodiments, updated guidance may be provided based on one or more user inputs. For example, updated guidance may be provided based on an indication that a user has performed one or more elements of a blood loss protocol. In some example embodiments, updated guidance may be based on both user input and an updated patient stage of the blood loss protocol. Providing updated guidance may 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, 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. 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 alarms through one or more speakers), a tactile notification (e.g., one or more vibrations). For example, it may be desirable to periodically or intermittently notify the user of the current patient stage, when the current patient stage changes, or both.

[0025] This article also describes an example system for providing guidance to a user during a medical procedure. In general, the example system discussed herein includes one or more processors configured to estimate the patient's blood loss, determine the current patient stage of the 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 may include multiple patient stages, and each patient stage may include one or more elements. For example, the elements of the patient stage may be or include recommending one or more user actions. Providing guidance to the user may include selecting (e.g., via a processor) one or more elements from the current patient stage of the blood loss protocol. Therefore, one or more processors of one or more systems for providing guidance to the user may be configured to select one or more elements from the current patient stage of the blood loss protocol. In addition, one or more processors may 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 the patient's updated blood loss, and one or more processors may determine the updated patient stage based on the updated patient blood loss. The example systems discussed herein may include a display configured to display information provided to a user, such as instructions (eg, one or more elements from a current patient phase of a blood loss protocol).

[0026] In addition, 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 a user based on the current patient stage of the medical parameter protocol. Any suitable medical parameter protocol can be used to guide a 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 a 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 such medical parameters may be estimated using one or more of the example methods described herein (e.g., estimated blood loss or estimated blood component concentration), using suitable instrumentation (e.g., a sphygmomanometer, a scale, a pulse oximeter, a thermometer, a flow meter coupled to an IV setup, etc.), or any suitable combination thereof.

[0027] 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 physicians 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 patient blood loss, determining a current patient stage of a blood loss protocol, and providing guidance to a user based on one or more of the current patient stages (e.g., further based on one or more user inputs).

[0028] Overview of the example method

[0029] One or more of the example methods described herein may be used to provide guidance to one or more users during a medical procedure. The provision of such guidance may include using one or more processors to perform one or more method operations (e.g., method steps). In general, such methods may include estimating a patient's blood loss and using the estimated blood loss to inform (e.g., generate, select, or otherwise determine) guidance to be provided to the user. In some example embodiments, such as in Figure 1 In the example embodiment depicted in , a method 100 of providing guidance to a user includes estimating 110 a patient's blood loss, determining 120 a current patient stage of a blood loss protocol based on the estimated blood loss, and providing 130 guidance to the user based at least in part on the current patient stage.

[0030] A blood loss protocol (e.g., selected from a variety of available blood loss protocols) may include multiple patient stages, which may be based on the severity of the patient's blood loss, and each patient stage may include one or more elements of that patient stage. In some example embodiments, one or more of the elements of the patient stage may include one or more recommended actions to be performed by a user to manage the patient's blood loss. In some example embodiments, the estimated patient blood loss may be used to determine the current patient stage of the blood loss protocol. Thus, the methods discussed herein may include estimating the 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 may be associated with a different patient stage of the blood loss protocol. Thus, the estimated patient blood loss may be associated with or otherwise correlated to a particular patient stage of the blood loss protocol, and this correlation may be used as a basis for determining the current patient stage of the blood loss protocol (e.g., among the various blood loss value ranges associated with the blood loss protocol, by comparing the estimated patient blood loss with the blood loss value range for that patient stage).

[0031] In some example embodiments, one or more of a plurality of estimated medical parameters may be used (e.g., individually or in combination) to determine the current patient stage in the blood loss 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 TEG), temperature, oxygen saturation, height, weight, age, BMI, gender, body fat percentage, intravenous infusion, or any suitable combination thereof. One or more of such medical parameters may be estimated using one or more of the methods described herein (e.g., estimated blood loss or estimated blood component concentration), using suitable instruments (e.g., a sphygmomanometer, a scale, a pulse oximeter, a thermometer, a flow meter coupled to an IV setting, etc.), or any suitable combination thereof. As an illustrative 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 old), then a suitable method may include determining the patient's current patient stage based on a combination of these medical parameters. For example, the current patient stage may be determined by comparing each medical parameter to a range of medical parameter values ​​associated with each patient stage of the blood loss protocol.

[0032] In some example embodiments, providing guidance during the medical procedure includes selecting one or more elements from a patient phase of a blood loss protocol (e.g., a current patient phase). For example, providing guidance may involve selecting one or more elements from a current patient phase of a blood loss protocol. Providing guidance may include displaying guidance (e.g., including the selected one or more elements) to a user via a display screen (e.g., displaying or otherwise presenting the one or more elements on a display screen of a mobile computing device), 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.

[0033] The guidance provided to the user may be based on the current patient stage of the blood loss protocol, user input, or both (e.g., based on generation, selection, retrieval, or otherwise determination thereof). In some example embodiments, the guidance may 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 to be selected by the processor to be included in the guidance to be provided). The guidance may be provided based on the blood loss stage and the user input. For example, a user may indicate that the user has performed a particular action, which may 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 may be updated based on user input, an updated current patient stage (e.g., based on an updated blood loss estimate), or both. Providing the guidance may include displaying the guidance, the updated guidance, or both on a display screen (such as on a display screen of a mobile computing device).

[0034] Example blood loss protocol

[0035] One or more of the example methods described herein may include using a blood loss protocol. For example, a bleeding protocol may provide a predetermined set of steps that are developed based on best practices that have proven desired results in medical procedures. A bleeding protocol may classify the severity of bleeding risk into stages (e.g., patient stages) based on the amount of blood lost by the patient. Each stage may provide a step for efficiently managing the patient's blood loss risk for the user. One or more of the various 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, although a bleeding scheme may be adopted in an operating room (e.g., a delivery room in a hospital), any suitable blood loss protocol may be used to provide guidance to the user in any medical procedure. In some example embodiments, a blood loss protocol may be or include a protocol for managing the patient's bleeding risk. In other example embodiments, a blood loss protocol may be associated with other types of risks associated with blood loss during a procedure (e.g., a medical procedure).

[0036] A blood loss protocol, such as a blood loss protocol for managing bleeding risk, can be divided into multiple patient phases. In some example embodiments, the patient phase of the blood loss protocol is based on the patient's estimated severity of blood loss. Each phase can be associated with one or more ranges of patient blood loss values, and each range can be defined by an upper threshold blood loss value, a lower threshold blood loss value, or both. Figure 2 2 is a schematic depiction of a blood loss protocol 200 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 risk of bleeding, or both. For example, patient stage 1 may represent the lowest risk of bleeding, while patient stage 4 may represent the highest risk of bleeding. One or more patient stages may be defined by a range of blood loss values ​​(e.g., a corresponding range). Figure 2, if the estimated amount of blood loss falls within a range 212 defined by thresholds (a) and (b), then the patient is classified as Patient Stage 1. Similarly, if the estimated amount of blood loss falls within a range 222 defined by thresholds (c) and (d), then the patient is classified as Patient Stage 2. If the estimated amount of blood loss falls within a range 232 defined by thresholds (e) and (f), then the patient is classified as Patient Stage 3. If the estimated amount of blood loss falls within a range 242 defined by 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 a patient may be classified into an appropriate current patient stage based on the estimated amount of patient blood loss, one or more other suitable patient criteria, or any suitable combination thereof.

[0037] In some example embodiments, multiple ranges (e.g., more than one discrete range of blood loss values) may be associated with the same patient stage within a blood loss protocol. Different patients, procedures, or conditions may affect the risk posed by different blood loss values. Therefore, each patient stage may be associated with multiple ranges. Each range may be associated with a medical procedure, a patient condition, a patient state, or any suitable combination thereof. For example, each stage may be associated with a first range defined by a threshold blood loss value for a patient undergoing vaginal delivery and a second range defined by a second threshold blood loss value set for a patient undergoing cesarean section. The various ranges associated with each stage may illustrate any suitable parameters. For example, each stage may be associated with different ranges for males and females, patients with different BMI classifications, children and adults, patients exhibiting specific conditions or risk factors and patients not exhibiting specific conditions or risk factors, or any suitable combination thereof.

[0038] Each patient phase of the blood loss protocol may include one or more elements of that patient phase. In some example embodiments, each element may be or include a recommended action to be performed by a user to effectively manage the amount of blood loss in a patient. For example, an element of the patient phase of the blood loss protocol may be or include a suggestion to the user to: contact a blood bank to request an amount of blood for transfusion, start a transfusion, request additional support personnel, apply pressure to a wound, suture or pack a wound, administer an IV, perform massage or other types of therapy, apply ointment, administer medication (e.g., orally or otherwise), or any suitable action. An element of the patient phase may 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, suggesting to the user an approximate time that a transfusion may be necessary if the patient's blood loss continues at a specific rate, or any suitable combination thereof. An element may also be or include instructions 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 phase 1, elements 224a-224d in patient phase 2, elements 234a-234b in patient phase 3, and elements 244a-244e in patient phase 4 of the blood loss protocol 200 are shown. Figure 2 As depicted in , the number of elements in each patient phase of the blood loss protocol 200 need not be uniform; different patient phases may have different numbers of elements. Additionally, each patient phase may include any suitable number of elements. In some example embodiments, one or more elements of the blood loss protocol may be ordered 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 FIG. 1 shows the elements arranged in a flow chart. In other example embodiments, the elements may not be ordered in the blood loss protocol (e.g., in a scenario where the order of the elements depends on user input). In addition, certain elements may appear in multiple stages. That is, each element need not be unique to a particular stage. For example, a blood transfusion may be desired in both Patient Stage 3 and Stage 4. Therefore, both Patient Stages 3 and 4 may include an element that recommends that the user perform a blood transfusion.

[0039] Fig.11 An example embodiment of a blood loss protocol that may be used to provide guidance to a user is depicted. Fig.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 may be referred to as "criteria". As discussed above, a range of blood loss values ​​may be associated with more than one patient stage based on various factors (such as the patient's condition). For example, Fig.11Patient Stage 1 (1020) of the protocol is associated with two blood loss ranges, one for vaginal births (>500mL blood loss) and the other for cesarean sections (>1000mL blood loss). Each patient stage of the protocol is associated with multiple elements. For example, Stage 2 (1030) of the blood loss protocol contains several elements that are recommended actions that the user can be instructed 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 uterotonics, notify a blood bank, and the like. In some example embodiments, not all elements in a given patient stage are appropriate to perform on every patient. For example, some elements in Patient Stage 2 are specific to the type of delivery being performed (e.g., if vaginal, then repair vaginal lacerations, perform D&C, and place an intrauterine balloon; if cesarean, then check the site and place an intrauterine balloon). However, Fig.11 The blood loss protocol depicted in is illustrative only and includes examples of various guidelines, elements, or both that may be included in a blood loss protocol.

[0040] 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, or tablet). In some example embodiments, one or more blood loss protocols are stored in the memory of a remote device and can be accessed wirelessly. For example, the blood loss protocol may be stored in a cloud-based storage system. The user may upload the blood loss protocol to the memory of the 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 the user to adjust one or more parameters of the blood loss protocol. In some example embodiments, the user may be able to set thresholds for ranges or other patient criteria associated with one or more patient stages of the blood loss protocol. As another example, one or more user settings may allow the 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 stages). 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 can 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 procedures, or any other suitable information for customizing the blood loss protocol can be manually entered by the user, or can be received by other means (e.g., electronic or wireless transmission). In addition, updated versions of the blood loss protocol can be downloaded to the server and storage automatically or by the user.

[0041] Example of estimating blood loss

[0042] 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 obtain an estimated patient's blood loss. In some example embodiments, one or more image analysis techniques are used to estimate a patient's blood loss.

[0043] For example, as further described below, estimating blood loss can include analyzing an image depicting one or more fluid-containing matrices (such as fluid containers, surgical items (e.g., surgical fabrics, such as surgical sponges), or both). Estimation of blood loss can include extracting features (such as color parameters) from the image and associating the features with estimated blood component concentrations. The estimated blood component concentrations can be used to determine the volume of fluid in the fluid-containing matrix. The volume of fluid in the matrix 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 matrices (e.g., among a plurality of such matrices). As another example, as further described below, estimation of blood loss can alternatively or additionally include using weight information to determine the estimated blood loss of the patient. For example, estimation of blood loss can include weighing one or more fluid-containing matrices (e.g., surgical items, fluid containers, etc.), and associating 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 fluid level markings. Thus, one or more of the example methods discussed herein may include analyzing a plurality of fluid containers, surgical items, or both to estimate patient blood loss.

[0044] Example Image Analysis Technique for Estimating Blood Loss

[0045] In some example embodiments, the estimation of the amount of blood loss in a patient includes using one or more image analysis techniques to determine the amount of blood in one or more fluid-containing matrices (such as one or more fluid containers, surgical items (e.g., surgical fabrics or sponges, etc.), or any suitable combination thereof. For example, the estimation of the amount of blood loss in a patient may include one or more of the methods described in U.S. Pat. No. 8,792,693 and U.S. Pat. No. 8,983,167, which are incorporated herein by reference in their entirety. In general, as Figure 3 As depicted in the schematic block diagram in , a method 300 for estimating blood loss in a patient using one or more images depicting one or more fluid-containing matrices may include receiving 310 an image of a fluid-containing matrix, selecting 320 a region of the image that includes at least a portion of the fluid-containing matrix, extracting 330 features from the selected region, correlating 340 the extracted features with a concentration of a blood component within the matrix, and estimating 350 an amount of a blood component within the matrix based on the concentration of the blood component within the matrix.

[0046] For example, Figure 3As shown in , a method 300 for estimating blood loss may include receiving 310 an image of a fluid-containing matrix. The image may be static, 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 may 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 may be used to generate an image of a fluid-containing matrix. A processor (e.g., a processor of a mobile device) may receive the image, perform image processing and analysis, or both, to estimate blood loss. The image may depict all or part of the fluid-containing matrix, and the image may depict multiple fluid-containing matrices. Figure 3 The example method depicted in 320 includes selecting 320 a region of an image. The selection of the region of the image may include selecting a region of the image corresponding to a fluid-containing matrix. For example, one or more region selection methods may utilize edge detection techniques, machine learning, or both to identify and isolate a fluid-containing matrix in the image. The selection of the region of the image may include identifying a portion of the image that contains blood or other fluid. For example, the selection of the region of the image may include detecting a liquid level in a tank or other fluid container and isolating a portion of the image corresponding to the fluid, detecting and isolating a fluid-saturated portion of a surgical item (such as a surgical fabric), or any suitable combination thereof.

[0047] Figure 3 The example method 300 depicted in also includes extracting 330 features from the selected region of the image. The extracted features may be features indicating the concentration of blood components in the fluid-containing matrix. The extracted features may be colors (e.g., red), color intensity (e.g., red value), brightness, hue, saturation value, brightness value, glossiness value, or other color-related values ​​in one or more component spaces (such as red, blue, green, cyan, magenta, yellow, key, or lab component spaces). In some example embodiments, the extraction of features may include extracting one or more features that generate a histogram of various colors or color-related values ​​in a set of pixels within the selected region of the image.

[0048] Figure 3The example method 300 depicted in the figure also includes correlating 340 the extracted features with the blood component concentration of a portion of the fluid-containing matrix. In general, correlating the extracted features with the blood component concentration may include correlating the extracted features with a value indicating the amount of blood in the fluid-containing matrix. For example, the correlation of the extracted features with the value may include transforming one or more features (e.g., color features) extracted from the image into an estimated concentration of blood components in a fluid-containing matrix (e.g., a fluid tank or a surgical item). The blood component may be any 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 blood components may be implemented or otherwise based on one or more parameter 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 blood components in the fluid in the fluid-containing matrix (e.g., a fluid tank).

[0049] like Figure 3 As shown in , the example method 300 involves extracting 330 one or more features (e.g., from pixel clusters) 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 a 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 color intensity in a 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 the template image. Each template image may include a pixel cluster 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 a pixel cluster labeled with volume, mass, density, etc., per unit volume of fluid or per pixel unit of any other liquid or solid in a tank. 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. Therefore, the selected image area, pixel, pixel cluster or any suitable combination thereof can be paired with the closest matching template image identified by the K-nearest neighbor method, and the selected image area, pixel, pixel cluster or its combination can be estimated to depict the blood component concentration associated with the closest matching template image. The estimation of blood component concentration can also aggregate, average or otherwise combine pixel cluster labels to estimate the output of the total blood component concentration of the fluid in the fluid matrix. However, various example embodiments of the methods discussed herein can include associating the extracted features with the concentration of blood components in the matrix via any other suitable non-parametric method or technology.

[0050] In another example, absolute differences in pixel intensity (e.g., red, green, or blue intensity or color value, or any suitable combination thereof) can be used for template matching. Such absolute differences in pixel intensity can be calculated at wavelengths of light associated with blood components (e.g., at approximately 400 nm for estimating hemoglobin concentration). More specifically, the sum of absolute differences in pixel intensity can be used to compare pixel intensities between the container image region and each template image. The best matching template image is identified when the sum of absolute differences is substantially minimum compared to the sum of other absolute differences calculated for the image region and other template images. Thus, the image region can be paired with the closest 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 closest matching template image.

[0051] In yet another example, the estimation of blood component concentration may include extracting 330 features from pixel clusters within a selected region of the image, and implementing a parameter model or function to mark each pixel cluster with a blood component concentration. As described in U.S. Patent No. 8,792,693, the estimation of blood component concentration may include inputting (e.g., inserting) one or more extracted features from a pixel cluster into a parameter function to substantially directly transform one or more extracted features from the pixel cluster into a blood component concentration. This process may be repeated for each other pixel cluster in the selected region. As described above, one or more extracted features may include any one or more of color intensity in a red component space, color intensity in a blue component space, color intensity in a green component space, or any suitable combination thereof. The parameter function may be or include a mathematical operation or algorithm that associates color intensity with hemoglobin mass per unit volume of fluid. In general, the color values ​​of the template image may be used to train or generate a parameter model (e.g., in the form of a mathematical function, curve, or algorithm) that associates pixel color values ​​with blood component concentration.

[0052] The reflectivity of oxygenated hemoglobin (HbO2) at certain wavelengths of light can indicate the hemoglobin concentration per unit volume of fluid. Therefore, in some example embodiments, for each pixel cluster in a set of pixel clusters in a selected area of ​​an image, the extracted feature can be or include one or more reflectivity values ​​at a specific wavelength. The association of the extracted feature with the concentration can include converting each reflectivity 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. In addition, because 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%). Furthermore, extracting features from the selected region may include accessing a most recently measured hematocrit or estimating the patient's current hematocrit (e.g., as described in U.S. Pat. No. 9,936,906, which is incorporated herein by reference in its entirety), and association of the extracted features may transform the estimated red blood cell concentration into an estimated extracorporeal blood concentration using the measured or estimated hematocrit. However, association of the extracted features with blood component concentrations may implement any other parametric analysis, non-parametric analysis, or both, on individual pixels or clusters of pixels 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., a fluid tank).

[0053] The estimation 350 of the amount of blood components in the fluid matrix can include determining the total volume of the fluid contained in the matrix. In some example embodiments, the information about the weight of the matrix, the liquid level in the matrix, the dimension of the matrix or any suitable combination thereof can be used to determine the fluid volume in the matrix. For example, the weight information can be combined with the known approximate density of the fluid in the matrix to obtain the fluid volume of the fluid in the matrix. In another example, the liquid level of the matrix of the example form of the tank is combined with the dimension of the tank and can be used to determine the volume of the fluid in the tank. In another example, the dimension of the surgical item (for example, surgical fabric) can be used to determine the surface area of ​​the surgical item, which can be combined with the information about saturation level and blood component concentration to determine the volume of the fluid in the surgical item.

[0054] In some exemplary embodiments, the estimation of blood content in the fluid-containing matrix includes estimating blood content based at least in part on the liquid level in the container (e.g., fluid tank), which can form all or part of the fluid-containing matrix. For example, the liquid level in the container can be used to determine the volume of the 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 exemplary 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. The estimation of the liquid level in the container can involve associating a portion of the selected area of ​​the image with the liquid level in the tank. For example, the estimation of the liquid level can include identifying the surface of the fluid in the tank and the base of the tank (e.g., the lowest level of the fluid in the tank), and estimating the liquid level in the tank based on this data. In some exemplary embodiments, the processor can fit a parameter function (e.g., sigmoid) to the intensity distribution of the selected area corresponding to the anti-glare strip on the tank to estimate the fluid height therein. In other example embodiments, the processor may associate pixels in the selected region with fluid (e.g., pixels that are substantially red) and calculate upper and lower limits for the fluid in the tank based on the distribution of the y-coordinates of the associated pixels. In such example embodiments, the processor may define the upper limit as the 95th percentile of the y-coordinates, or the processor may start with the 99th percentile of the y-coordinates of the associated pixels and decrement the percentiles until the red color of two adjacent pixels does not change beyond a predetermined threshold, but the process may function in any other manner to identify, ignore, or both any "false positive" "red" pixels that do not correspond to fluid in the tank.

[0055] In some exemplary embodiments, the estimation of the blood content in the fluid-containing matrix includes estimating the blood content based at least in part on an estimated blood volume in a fluid-containing matrix, such as a surgical item (e.g., surgical fabric), by generating information about the dimensions of the surgical item (e.g., an estimated surface area of ​​the surgical item, an estimated surface area of ​​a soiled portion of the surgical item, a pixel count of a portion of the surgical item, a pixel count of a soiled portion of the surgical item, or any suitable combination thereof. In some exemplary embodiments, the estimation of the blood content in the fluid-containing matrix can enable object recognition to isolate objects within the field of view of the optical sensor, within the 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 the object with known dimensions, or both, and comparing the position of the matrix-containing fluid in the image to the object with known dimensions. In other exemplary embodiments, the determination of the dimensions of the fluid-containing matrix can involve determining the number of pixels along the axis of the fluid-containing matrix, and using information about the distance from the optical sensor to the fluid-containing matrix to establish a relationship between the number of pixels and the numerical dimension.

[0056] The estimation 360 of the amount of blood in the fluid-containing matrix can utilize the concentration of the blood component in the fluid-containing matrix (e.g., related or determined in other ways based on the extracted features) and the total fluid volume in the determined matrix to estimate the amount of the blood component in the fluid-containing matrix. In general, the estimation of the amount of the blood component can include calculating the amount of the blood component (e.g., mass, weight, volume, cell count, etc.) by multiplying the estimated volume of fluid in the fluid-containing matrix by the estimated concentration of the blood component in the fluid in the fluid-containing matrix (e.g., tank). In addition, the estimated amount of blood loss (e.g., lost blood volume) can be estimated by dividing the estimated amount of the blood component (e.g., hemoglobin) by the value of the serum blood component mass value, which value can be, for example, laboratory derived and entered by the user.

[0057] The estimation of the patient's blood loss can also include combining blood volume estimates from multiple substrates. For example, the estimation of the patient's total blood loss can include adding the blood volumes estimated in multiple fluid-containing substrates. The estimation of the patient's blood loss can include combining fluid-containing substrates from the same type (e.g., two or more fluid tanks) or different types of substrates (e.g., blood volume in tank blood volume estimates and estimated surgical items (such as surgical gauze sponges, surgical towels, surgical sheets, surgical dressings or any suitable combination thereof)). The example methods discussed herein can include adding the estimated patient blood loss data to the patient's case, triggering an alarm once a threshold value extracorporeal blood volume estimate is reached, or estimating the current patient's hematocrit based on the initial patient's hematocrit, fluid IV, blood transfusion and the estimated total blood loss, such as described in U.S. Patent No. 9,936,906.

[0058] Other Examples of Estimating Patient Blood Loss

[0059] Some methods of estimating the amount of blood lost by a patient may not utilize image analysis. However, as described above, one or more techniques involving image analysis may be combined with other techniques to estimate the amount of blood lost by a patient.

[0060] In addition to using the above-mentioned weight information (for example, combining the weight information with the blood component concentration derived from the extracted image features to estimate the blood content of the matrix), 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 matrices can be used to estimate the blood volume contained in one or more fluid-containing matrices using predetermined information about the blood content of one or more fluid-containing matrices. In some cases, it can be generally assumed that the fluid contained in the matrix is ​​all or substantially all blood (for example, human blood). The known density of such blood can be used to associate the fluid weight (for example, as estimated as the difference between the "wet" weight and the "dry" weight of the fluid-containing matrix) in one or more fluid-containing matrices to the fluid volume. In other cases, the blood component concentration in the fluid can be known with a reasonable certainty level without using image analysis, and the blood component concentration can be used to estimate the blood volume in the fluid-containing matrix. Any suitable weight detection system or method can be used to determine the weight of the matrix configured to contain fluid. For example, one or more such methods can include placing articles (such as fluid containers or surgical fabrics) on a scale to determine the weight. In some example embodiments, weight information (e.g., indicated weight) may be received by a processor to estimate the amount of blood contained in the fluid-containing matrix based on the weight information. The weight information may be automatically transmitted to the processor (e.g., wirelessly transmitted from a scale) or may be manually input by a user (e.g., input into a computing device such as a smartphone, tablet, laptop, etc.).

[0061] In some example embodiments, one or more manual techniques may be used to estimate the amount of blood lost by a patient. For example, blood may be collected into a fluid tank, and a volume indicator (e.g., a mark) on the tank may be used to estimate the amount of blood in the tank. The fluid tank may be placed in a position close to the patient so that the blood lost by the patient may be drained into the tank. A user may observe one or more marks on the tank, and when the fluid reaches the level of each mark, the one or more marks may indicate the volume of fluid in the tank. In some example embodiments, a user manually inputs the volume (e.g., indicated by the liquid level) into a processor (e.g., a 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 level in the tank and automatically transmit the liquid level information to the processor.

[0062] U.S. Patent Publication No. 2018 / 0199827, which is incorporated herein by reference in its entirety, describes an example of a non-image-based method for quantifying the fluid lost by a patient during a medical procedure (e.g., during childbirth, surgery, etc.). One or more of the 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 the estimate can be updated and displayed substantially in real time during the medical procedure, at the end of the medical procedure, or both. During the 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 bags, other fabrics, other absorbent items, or any suitable combination thereof. One or more surgical fabrics or other absorbent surgical items may be placed in a bag (e.g., a sponge counting bag) for tracking purposes, sanitation purposes, or both. Additionally or alternatively, extracorporeal fluids lost by a 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 may involve collecting lost fluids with specialized containers. For example, during a delivery procedure, a sheet having at least one pocket (e.g., a blood collection sheet having a triangular pocket) may be placed under the patient for collecting 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) may be estimated based on the weight (mass) measured when the surgical item contains the fluid, or may be measured based on a volume indicator or marking 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 may be combined with an estimate 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 may be estimated at any particular point during a medical procedure, after a procedure, or both.

[0063] Example of determining the current patient phase of a blood loss protocol

[0064] 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 amount of patient blood loss. As described above, one or more of a variety of methods may be used to determine the estimated amount of patient blood loss. The determination of the current patient stage of the blood loss protocol may include comparing the estimated amount of 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., a rate of transfusion, a vital sign, 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 be compared to the estimated amount of patient blood loss. Additionally, as described above, a plurality of medical parameters may be used to determine the current patient stage of the blood loss protocol.

[0065] In some example embodiments, a processor may receive an estimated patient blood loss, access a blood loss protocol stored in a memory of the device, and compare the estimated patient blood loss with a threshold associated with each range of the blood loss protocol to determine a current patient stage. The processor may then transmit the current patient stage to one or more subsequent method steps so 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 embodiment where the 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 the processor 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 by wired communication). In some embodiments, 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, determination of the current patient stage includes accessing data related to estimated blood loss from a memory of one or more devices.

[0066] In other example embodiments, the estimated patient blood loss may be manually entered by a user, adjusted or updated by a user, or both. For example, in situations where patient blood loss is estimated using one or more manual techniques, such as by using markings on a fluid container to determine blood volume, using weight information to estimate blood loss, or both, a user may wish to manually enter the patient's blood loss into the system for use in determining the current patient stage. Additionally, in some example embodiments, a user may wish to adjust or update an automatically transmitted patient blood loss. For example, a situation may be where the patient's blood loss is determined by a processing system using an image of a fluid tank, surgical fabric, or both, but the system does not capture additional blood loss information. Therefore, the user may then wish to add additional blood loss to the estimate. Fig.14 An example of a GUI 1300 is shown that allows a user to manually enter a blood loss value from a fluid container or to enter a fluid volume value from which a blood loss value may be derived. Fig.14 The GUI 1300 in allows a user to adjust the volume of a first fluid (e.g., amniotic fluid) in a fluid container (e.g., a V-shaped drape) using one slider icon 1310 and to adjust the total volume of fluid in the fluid container using another slider icon 1320. For example, the position of a marker along slider icon 1310, slider icon 1320, or both can be adjusted by the user clicking and dragging the marker itself, by selecting an increment or decrement button, or both. In the depicted example, a blood loss value can be determined as the difference between the total fluid volume entered via slider icon 1320 and the amniotic fluid volume entered via slider icon 1310 (e.g., assuming that the two primary fluids in the fluid container are amniotic fluid and blood). When the user has completed adjusting the value of each metric, the user can press a “Set Value” button 1330 to store the information entered by the user, the amount of fluid derived therefrom (e.g., a blood loss value), or both. Although Fig.14 GUI 1300 is shown to allow a user to enter the amount of fluid contained in a V-shaped sheet, but a similar display can be used to allow a user to enter the amount of fluid (e.g., blood) in any type of container. Similarly, while 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 in a numerical value, reciting a number parsed using voice recognition technology, etc.) can be used as appropriate.

[0067] For example, the processor may receive an estimated patient blood loss value for patient A of 1200 mU of blood. A blood loss protocol stored in a 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 a current patient stage may include comparing the estimated blood loss of patient A to thresholds defining a range associated with patient stage 1, a range associated with patient stage 2, and a range associated with patient stage 3. Based on the comparison, the processor will determine that the estimated blood loss of patient A of 1200 mU falls between the thresholds of 1000 mU and 1500 mU, and therefore 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.

[0068] Examples of providing guidance

[0069] One or more of the methods discussed herein may include providing guidance to a user based on one or more of a current patient phase of a 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 phase of the blood loss protocol. As described above, each patient phase may include one or more elements that may be selected by a processor. In some example embodiments, one or more elements of the current patient phase of the blood loss protocol may be or include one or more recommended user actions.

[0070] Example of determining guidance to provide to users

[0071] Figure 4 4 is a schematic depiction of a method 400 of providing guidance to a user. In general, providing guidance to a user includes selecting 412 one or more elements from a patient stage (eg, patient stage 410, 420, 430, or 440) to provide as guidance. Figure 4In the example embodiment shown in , the guidance 416 includes four elements selected from the patient stage 420. However, any suitable number of elements may be selected to provide 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 may 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), medical procedures being performed on the patient, hospital, physician, one or more actions that the user has performed, or any suitable combination thereof. For example, the user input may indicate that the patient is obese and therefore at a higher risk of complications related to blood loss.

[0072] Based on this information about the patient, and based on the current patient stage, the guidance may include an element that recommends that the user prepare for a blood transfusion. User input may be received in any suitable manner, such as a user interacting with a mobile computing device (e.g., pressing one or more buttons on a mobile computing device to indicate completion of an element of a blood loss protocol). In some example embodiments, information about the patient, the medical procedure, the hospital, one or more physicians, one or more actions performed by a user, or any suitable combination thereof, may be automatically transmitted to and received by one or more processors. Thus, "user input" may be data that is automatically transmitted based on an action performed by a user, information obtained by a user, items manually entered by a user, or any suitable combination thereof.

[0073] In some example embodiments, one or more patient phases may include one or more elements that are conditionally selectable for provision as guidance. For example, one or more elements may be selectable based on an indication that the user has performed one or more specific actions or that one or more specific events have occurred (e.g., the one or more elements were not selectable prior to such performance or occurrence). In other words, a particular one or more actions or events may "unlock" one or more conditionally selectable elements and enable these one or more unlocked elements to be provided as guidance to the user at a later time. Conditionally selectable elements 418 are shown in FIG. Figure 4Schematically depicted by dotted lines in . However, after one or more events, user input, or both occur, one or more conditionally selectable elements may be reclassified as selectable. If certain elements are relevant in a limited situation, it may be desirable to classify those elements as unselectable (e.g., non-selectable or otherwise not selectable) 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, performed an IV transfusion, or started suturing a wound. Similarly, one or more patient stages may include conditionally unselectable elements (e.g., the element is disabled so that although the user selects the element, the functionality associated with the element is not performed) to provide as guidance. For example, after the user has performed a specific action or an indication that a specific event has occurred, one or more elements may be unselectable or hidden (e.g., one or more elements were selectable before this action or event occurred). In other words, a specific action or event can "lock" one or more conditionally unselectable elements and disable these one or more locked elements, thereby preventing them from being provided as guidance to the user afterwards. Thus, depending on one or more predetermined triggers (e.g., actions, events, or any suitable combination thereof), one or more elements may be unlocked (e.g., become available as guidance) or locked (e.g., become unavailable as guidance).

[0074] In some example embodiments, providing guidance to the user includes providing updated guidance to the user. The updated guidance may be provided based on any suitable indication or event, such as user input, an updated current patient blood loss stage, or any suitable combination thereof. The updated guidance may be provided based on user input. For example, the user may indicate that the user has performed a particular action, the patient has exhibited a certain condition, or both, which may prompt an updated list of elements to be selected to be provided to the user and then provided to the user. In some example embodiments, the updated guidance may be provided based on the updated patient stage of the blood loss protocol. For example, the estimation of blood loss may 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 may be determined at various time points during the medical procedure, and an updated patient stage may be determined based on the updated patient blood loss. Thus, updated guidance may be provided to the user based on the updated patient stage, such as updated based on the updated blood loss. In some example embodiments, updated guidance may be provided to the user or patient, for example, based on both user input and the updated patient stage (e.g., based on the updated blood loss).

[0075] Figure 55 is a schematic diagram of a method 500 of providing guidance to a user, wherein providing guidance includes providing 530 initial guidance and providing 560 updated guidance. As described above, the method 500 of providing guidance to a user may include estimating 510 a patient's blood loss, determining 520 a 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 represented by the dashed arrow pointing from the providing 530 of guidance, providing the updated guidance may be based on one or more types of information. Providing the updated guidance may include estimating 540 an updated blood loss of the patient, and determining 545 an updated patient stage of the blood loss protocol based on the updated blood loss. In some example embodiments of the method 500, providing 560 the updated guidance includes receiving 550 user input. Thus, providing 560 the updated guidance may be based on the user input, the updated patient stage (e.g., updated based on the patient's updated blood loss), or both.

[0076] Examples of providing definitive guidance

[0077] Providing guidance (e.g., including any updated guidance) may include displaying or otherwise presenting guidance, other information, or both to the user. For example, providing guidance to the user may include displaying one or more elements selected by the processor on a display (e.g., a display screen). The display may be a display screen that is part of a mobile computing device (such as a tablet, a laptop, a 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 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 the medical procedure room, such as near a medical department desk (e.g., a nurse's station), a lounge, a public area, etc. This allows medical staff outside the immediate vicinity of the patient to understand the guidance provided, the patient's status (e.g., in a substantially real-time manner), or both.

[0078] Figure 6 An example of a GUI for a display screen of a mobile device for displaying various elements of a blood loss protocol is depicted. Figure 6 The example GUI depicts the current patient stage presented to the user (in Figure 6 is a series of elements of "Phase 2"). Figure 6 As depicted in , 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 elements that are 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 next to each element so that completed elements may be indicated by a mark. Figure 6 Boxes with completed items indicated by an "x" are shown, but any suitable indicia may be used (e.g., a check mark, a slash, an asterisk, a filled box, text with an element crossed out, etc.). As described above, one or more elements may be marked as completed, automatically or via user input (e.g., via manual user input via a touch screen, via narrated user input that may 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 require completion). The display may adjust the color intensity based on whether the element has been completed (e.g., uncompleted elements are listed in a darker color or black, while completed elements are lightened or grayed out). Fig.12 Another example GUI (eg, for a display screen of a mobile computing device) displaying various elements of a blood loss protocol is depicted. Fig.12 The GUI in depicts a series of example elements presented to a user for a patient phase of a blood loss protocol (labeled “Phase 1”).

[0079] The elements of the displayed guidance can be arranged in any suitable manner. In some example embodiments, some or all elements can be grouped into categories and displayed in combination with one or more of various titles. For example, some or all elements can be grouped into categories, such as assessment (e.g., assessing cumulative blood loss, assessing vaginal wall, assessing cervix, assessing placenta, assessing uterine cavity, measuring patient vital signs, etc.), medication (e.g., administering 250 mg of misoprostol), notification (e.g., notifying OB of the patient's stage of the blood loss protocol, notifying the blood bank of the patient's blood type), preparation (e.g., preparing transfusion equipment) or any suitable combination thereof. In some example embodiments, some or all elements are displayed in the order in which they should be completed. In some example embodiments, some or all elements are arranged based on a variety of organizational methods (e.g., arranged into categories, and then in the order of completion expected or indicated within each category). However, elements can generally be arranged on the display in any suitable manner.

[0080] In some example embodiments, additionally or alternatively, providing guidance includes providing guidance through one or more audio prompts, tactile prompts, or any suitable combination thereof. For example, guidance (e.g., one or more selected elements from the current patient stage) can be recited or otherwise output from a speaker device. As another example, one or more tactile prompts (e.g., vibrations from a vibration motor with or without flashing light from a mobile computing device or other device) can be associated with one or more elements of guidance (e.g., color-coded to a specific recommended action or category of action). Providing guidance to the user can also include providing an indication when the guidance is updated. In some example embodiments, an audio or visual prompt can indicate that an updated guidance has been provided. This can provide the benefit of alerting the user that a change has been made to the displayed elements. As discussed above, it can be in response to input (e.g., manual or automatic 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. Therefore, when guidance is updated based on user input (e.g., as a result thereof), an updated patient stage, or both, a notification can be provided. Any suitable notification may be used to notify the user of the updated guide, such as a sound (e.g., a ring, beep, buzz, hum, or any suitable combination thereof), a vibration, a flash, a color change, a dynamic visual showing elements being swapped out, or some or all of the blood loss protocol being scrolled, any suitable combination thereof, or any other suitable prompt. In other words, one or more alerts or notifications may be provided to prompt the user to view the guide (e.g., a buzzer or beep may be output to draw the user's attention to a display providing the guide).

[0081] Displaying guidance to the user may include displaying guidance consisting of one or more elements selected from the current patient stage. However, the display of guidance may also include displaying one or more elements from additional patient stages. For example, displaying guidance to the user may include displaying guidance from a previous patient stage, for example, if there are one or more elements that the user did not complete in the previous patient stage but should still complete. In addition, providing guidance may include providing one or more notifications that the user has not performed an element. Such notifications may 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 prompts (e.g., by providing a noise or verbal prompt to indicate that an element has not been completed), via one or more tactile prompts (e.g., by causing vibrations from a vibration motor in a mobile device), or any suitable combination thereof. In some example embodiments, the provision and display of guidance may 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 serious patient stage, the processor may begin to "queue" one or more additional elements from a subsequent patient stage in anticipation of the patient's condition worsening. In some example embodiments, one or more elements from a subsequent stage may be presented together with one or more elements from the current patient stage. Elements from subsequent patient phases may be distinguished from elements from the current patient phase. For example, elements from subsequent phases may be a different color, a different intensity, or may be separated by a line or marker to distinguish elements from different phases. For example, Figure 7 An example GUI for a display showing elements from stages 2 and 3 of a blood loss protocol is depicted. Elements from patient stage 2 appear at the top of the screen under a heading labeled "STAGE 2," and elements from patient stage 3 appear at the bottom of the screen under a heading labeled "STAGE 3" and are separated from the stage 2 elements by a dotted line.

[0082] Providing guidance to the user may include displaying one or more summary graphics, such as a chart or progress bar, of the patient's current blood loss associated with the patient's stage of the blood loss protocol. Figure 8An example of a summary graphic for a patient blood loss is shown. The summary graphic includes a status bar 710 with four patient stages of blood loss, indicated by changes 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 is also indicated in the display along with an estimated amount of blood loss. The summary graphic can show how many elements or steps in the blood loss protocol associated with each stage have been completed by the user, relative to how many total steps are presented to the user. That is, each segment of the status bar (e.g., each segment associated with a different patient stage) can have a score 730, 732 adjacent thereto (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 graphic shown in , the first patient phase of bleeding is marked with a score 730, indicating that 23 of 25 steps were completed for this patient phase. As another example, the second patient phase of bleeding is marked with a score 732, indicating that 11 of 11 steps were completed for this patient phase. Various information (e.g., current patient phase, location of marker icons, completed steps, etc.) can be updated throughout the medical protocol. Figure 8 An example of a summary graphic is shown, but any suitable graphic (such as a chart, graph, flow chart, table, or any suitable combination thereof) can be used to summarize information related to patient blood loss and track progress in compliance with the blood loss protocol. In addition, 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 time 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, Fig.13 An example GUI display 1200 is shown that provides a breakdown of the current patient stage 1210, the estimated cumulative blood loss for the patient 1220, and the sources 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.). Fig.13 The example GUI in also provides an indication 1240 that the scale is ready for use (e.g., to weigh a soiled item to estimate additional patient blood loss), and two user input buttons 1250 and 1260. Input button 1250 allows the user to indicate an adjusted blood loss measurement from a fluid container (e.g., a "V-Drape"), and input button 1260 allows the user to close the housing, indicating that the procedure is complete or that the user is otherwise done using the mobile application.

[0083] Examples of data storage and access

[0084] Providing guidance to a user may involve one or more of various methods of accessing and storing data. As described above, one or more blood loss protocols may be stored in the memory of one or more devices. In order to provide guidance to the user, one or more processors may access one or more blood loss protocols stored in the memory. As described above, providing guidance to the user may include selecting one or more elements from the blood loss protocol and providing those one or more elements to the user. In some cases, it may be desirable to track and record information about one or more elements selected from the blood loss protocol and displayed to the user. Therefore, one or more of the methods discussed herein may include creating a data record of one or more elements provided to the user during the medical procedure. In addition, as previously described, guiding the user during the medical procedure may include receiving input indicating whether a particular element has been completed. For example, the element provided to the user may be a recommendation for the user to administer an IV to the patient. When the user completes this element, the processor may receive an indication that the element has been completed. The indication may be an indication that is automatically transmitted (e.g., wireless communication from an IV system indicates that it has been properly filled and connected to the patient), or the indication may be in the form of 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 may store information about whether one or more of the elements provided to the user (e.g., items provided as guidance) have been completed. In some example embodiments, determining whether an element is incomplete may 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 may also be useful to track and store information about each element, such as: the time the element was completed or ignored; the time the element was provided, the medical procedure in which the element was provided; the hospital where the medical procedure was performed (e.g., conducted); the doctor, nurse, or other medical staff member who performed the medical procedure; the identity of the user who completed the item; any other relevant information; or any suitable combination thereof. Thus, in addition to whether the element was completed, the data record may include any suitable type of information about each element provided to the user.

[0085] Storing and accessing information about guidance provided during a medical procedure may include creating and maintaining a data record with information about one or more elements provided to a user during a procedure. Fig. 9 is a diagram of an example data record used to store information about a process. Each box in the data record contains information associated with an element in the process. Each row contains information about one element, and each column represents a different piece of information about that element. Fig. 9In the example data record, the first column 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 element descriptors based on what is displayed to the user (e.g., the element description may be "perform a blood transfusion"). In other example embodiments, the data record may store element descriptors based on element numbers, element codes, or abbreviations. For example, providing guidance "perform a blood transfusion" may be stored in the data record as "TRNSF", or any suitable abbreviation, including numeric codes. In some example embodiments, a lookup table may be associated with the data record to indicate the full text of each element code or abbreviation. Fig. 9 The second column in the example data record shown in is the status indicator for the element, which indicates whether the element is completed. Fig. 9 The third column in the data record shown in is a timestamp (e.g., showing a 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 a guide). Fig. 9 The fourth column in the data record is the current patient phase of the blood loss protocol (e.g., the patient phase of the blood loss protocol associated with the patient's blood loss volume when the element was provided or when the element was completed or ignored). Fig. 9 Four labeled columns are included, but 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 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 status (e.g., "time / date"), one or more timestamps displayed to one or more users, elapsed time of the medical procedure, current patient phase of the blood loss protocol, one or more patient parameters (e.g., height, weight, sex, BMI, medical history, etc.), procedure information, hospital information, users who completed or ignored one or more elements, an estimated amount of patient blood loss, an indication of a patient's risk of bleeding or other complications, an estimate of the time by which a patient will reach an unacceptable level of blood loss, any other suitable information, or any suitable combination thereof.

[0086] The data records generated during the medical procedure can be used for various purposes, such as during the medical procedure, after the completion of the medical procedure, or both. During the medical procedure, the data records 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, stage, etc.). For example, as described above, certain elements of the blood loss protocol can be conditionally selectable. Therefore, providing guidance to the user can include accessing the data record during the medical procedure to determine whether the conditionally selectable elements are currently selectable to provide to the user as guidance. The data record can be used to provide the user with an indication of which elements have been completed. For example, when one or more indications indicating whether the user has completed an element are displayed, the processor can access the data record to determine, confirm, or both whether the element has been completed to determine whether the indication that the element has been completed should be displayed accordingly. 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 ignoring elements provided to the user. Therefore, the data record can be accessed to notify the administrator of the ignored elements. Information from the data log may also be used to determine whether usage complies with provided guidelines, as discussed below.

[0087] It is desirable to access the data record after the completion of the medical procedure. At the end of the medical procedure, the data record represents a partial or complete sequence of events of the medical procedure. Therefore, 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 data records to determine compliance with the blood loss protocol, from which one or more elements are provided to one or more users. This information can be used to determine whether a specific 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 properties of conditionally selectable elements or conditionally unselectable 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 records may be stored in any suitable format. In some example embodiments, storing information from the data records includes formatting the information into a chart, a spreadsheet, a list, or any suitable combination thereof. In other example embodiments, the storage and transmission of such information may include generating a chart or graph based on the data in the data records. Additionally, the raw data in the data records may be derived and / or manipulated in any suitable manner by any suitable program.

[0088] Other example changes

[0089] One or more of the methods discussed herein may include providing guidance during a medical procedure based on one or more other suitable kinds of medical parameter protocols. For example, such methods may include estimating a medical parameter of a patient and using the estimated medical parameter to inform guidance provided to a user. In some example embodiments, such as in Fig.15In the method depicted in , the method 1400 of providing guidance to a user may include estimating 1410 a medical parameter of a patient, determining 1420 a current patient stage of a medical parameter protocol based on the estimated medical parameter protocol, and providing 1430 guidance to the user based at least in part on the current patient stage. In general, the method 1400 may be similar to one or more of the methods described above regarding providing guidance based on a blood loss protocol, except that in the 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 prompt and accurate compliance with one or more best practices, one or more other protocols for patient medical care (e.g., medication, other actions), or any suitable combination thereof, thereby improving patient outcomes.

[0090] 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 instrumentation (e.g., a sphygmomanometer, a scale, a pulse oximeter, a thermometer, a flow meter coupled to a TN setup, etc.), or any suitable combination thereof.

[0091] The medical parameter protocol may include, for example, a plurality of 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 the patient stage may include one or more recommended actions to be performed by a user to manage the patient's health characteristics (e.g., to restore the medical parameter to an acceptable or normal range). In some example embodiments, determination of a current patient stage may involve comparing the estimated medical parameter to one or more medical parameter value ranges. Each range may be associated with a corresponding patient stage of the medical parameter protocol. Thus, an estimated medical parameter for a patient may be associated with a corresponding patient stage of the medical parameter protocol to determine the current patient stage, for example, by comparing the estimated medical parameter to a medical parameter value range associated with one or more of the various stages of the medical parameter protocol.

[0092] In addition, in some example embodiments, a plurality of estimated medical parameters are used individually or in suitable combinations to determine a 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 old), then the method of providing guidance to the user may include determining the current patient stage of the patient based on a combination of these medical parameters. For example, the current patient stage may be determined by comparing each medical parameter to a range of medical parameter values ​​associated with each patient stage of the medical parameter protocol.

[0093] The method may then include providing guidance (e.g., a series of protocol instructions specific to or associated with the current patient stage based on such combination of medical parameters), which may include, for example, administering certain amounts and quantities of medication to manage the patient's return to a normal medical range. Guidance specific to a value or range of values ​​for a medical parameter may be provided based on the protocol instructions for an associated condition. Providing such guidance may involve selecting one or more elements from the current patient stage of the medical parameter protocol. Providing guidance may also include displaying guidance (e.g., consisting of the selected elements) to a user via a display screen (e.g., a display screen of a mobile computing device), or providing guidance in any suitable manner (e.g., other notifications, such as other visual notifications, audio notifications, tactile notifications, etc.).

[0094] Overview of the example system

[0095] The example system described herein implements one or more of the example methods for providing guidance to a user discussed herein. Such a system for providing guidance to a user may include one or more processors configured to estimate the patient's blood loss, determine the current patient stage of the 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 may be configured to select one or more elements from the current patient stage of the blood loss protocol. In addition, one or more processors may 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 may include a display configured to display information to the user. Similarly, such a system for providing guidance to a user may include one or more processors configured to estimate the patient's medical parameters, determine the current patient stage of the 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.

[0096] like Fig.10As shown in , 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 involve the use of one or more blood loss protocols or one or more other medical parameter protocols, also stored in the memory 920. For example, the system 900 may include one or more processors 910 configured to perform 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 being 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 being associated with one or more ranges of medical parameter values, and each patient stage may include one or more elements. In general, the system 900 may be configured to substantially perform one or more of the methods described in further detail above. As described above, Fig.10 As further shown in , 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 instructions 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 a patient, a user, or both during a medical procedure (e.g., in an operating room) to guide the user during the medical procedure. For example, the system 900 may include, at least in part, 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 a medical procedure (e.g., in an operating room), camera 930, display 940, or both may be located substantially proximate to a patient, a user, or both, and processor 910 may be located at a remote location (e.g., within the operating room, separate from the camera, display, or both, or outside the operating room), communicating with camera 930 and display 940 via a wired or wireless connection or other network.

[0097] In general, the one or more processors 910 may be configured to execute instructions stored in the 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 a computer executable component integrated with an application, applet, host, server, network, website, communication service, communication interface, hardware / firmware / software elements of a user's 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 device (e.g., CD or DVD), hard drive, floppy drive, or any suitable device.

[0098] As described above, the one or more processors 910 may be integrated into a handheld or mobile device. In other example embodiments, the one or more processors 910 may be incorporated into a computing device or system, such as a cloud-based computer system, a mainframe computer system, a grid computer system, or other suitable computer system. Additionally or alternatively, the one or more processors 910 may be incorporated into a remote server that receives information about an estimated patient blood loss, compares the estimated patient blood loss to a threshold value defining a range associated with a patient stage of a blood loss protocol to determine a current patient stage, and selects elements from the current patient stage to provide guidance to a user.

[0099] 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, the one or more images may be used to estimate the amount of blood loss of a patient. 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 optical devices, one or more filters (e.g., one or more color filter arrays, such as Bayer pattern filters), or any suitable combination thereof. As another example, the camera 930 may include multiple image sensors paired with suitable corresponding optical devices, 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 device component to enable the camera 930 to generate an image. Camera 930 may be configured to generate any number or types of suitable images, such as images depicting a fluid-containing substrate, such as a fluid container (eg, a can), a surgical item (eg, surgical drapes), or any suitable combination thereof.

[0100] The camera 930 can be configured to transmit the image to the processor 910 for analysis, to a database storing the image, or to both. As previously described, the camera 930 can be integrated in the same device with one or more other components of the system 900, or the camera can be a separate component that transmits the image data to the other components.

[0101] 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 instructions or other information to a user (e.g., a physician, nurse, etc.). Such information may be generated by system 900 and include one or more elements of a patient phase of a blood loss protocol (e.g., an action to be performed by a user), patient information, an estimated blood loss of a patient, a current patient phase of a blood loss protocol, one or more notifications, a summary graph of the blood loss protocol and patient blood loss, one or more images of surgical fabrics, one or more quantitative metrics characterizing fluid in surgical fabrics, or any suitable combination thereof. 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.

[0102] 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 a user to provide an indication that the user has completed an element of a blood loss protocol; provide information about a patient, a procedure, a hospital, etc.; manipulate an image containing a fluid matrix (e.g., zoom, crop, rotate, etc.); or any suitable combination thereof. As another example, the user interface may enable a user to select one or more display options (e.g., fonts, colors, languages, etc.), various content (e.g., patient information, quantitative metrics or other fluid-related information, information about the current patient stage of a blood loss protocol, alarms, etc.), or any suitable combination thereof. In such example embodiments, the display 940 may be user interactive and include a resistive or capacitive touch screen that responds to skin, 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.

[0103] In some example embodiments, the system 900 may additionally or alternatively include an audio system that conveys information to the user. The display 940, the audio system, or both may provide the user with current audio prompts or other notifications, which may assist the user in executing elements of a blood loss protocol or other medical parameter protocol.

[0104] like Fig.10 As shown in , display 940 can be integrated into the same device as one or more components of system 900. Additionally or alternatively, display 940 can include an independent separate monitor, screen, or other suitable display.

[0105] In some example embodiments, one or more of the systems discussed herein (e.g., system 900) may also include items useful for tracking and quantifying patient blood loss, such as a matrix configured to contain a fluid such as blood. For example, such systems may include a fluid tank, 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. In addition, such systems may include a stand or mount configured to hold a mobile device on which guidance is to be displayed.

[0106] In addition, such systems may include one or more items configured to estimate one or more other medical parameters, such as medical parameters used to manage patient care based on a medical parameter protocol. For example, one or more instruments that measure 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 fluids, etc., or any suitable combination thereof. Such instruments may include sphygmomanometers, scales, pulse oximeters, thermometers, flow meters coupled to IV settings, etc.

[0107] For the purpose of explanation, the above description uses specific nomenclature to provide a thorough understanding of the present subject matter. However, it will be apparent to those skilled in the art that, in order to practice the present subject matter, specific details are not required. Therefore, for the purpose of illustration and description, the foregoing description of the specific embodiment of the present subject matter is presented. They are not intended to be exhaustive or to limit the present subject matter to the precise form disclosed. In view of the above teachings, many modifications and variations are possible. Example embodiments are selected and described to explain the principles of the present subject matter and its practical application. These example embodiments thus enable other persons skilled in the art to utilize the present subject matter and various example embodiments with various modifications suitable for the intended specific purpose.

[0108] The following enumerated description describes various examples of methods, machine-readable media, and systems (eg, machines, devices, or other apparatuses) discussed herein.

[0109] A first example provides a method of providing guidance during a medical procedure, the method comprising:

[0110] At one or more processors:

[0111] Estimate the patient's blood loss;

[0112] Determine the current patient phase of the blood loss protocol based on the estimated blood loss; and

[0113] Provides guidance to the user based on the current patient stage of the blood loss protocol.

[0114] A second example provides a method according to the first example, wherein estimating blood loss comprises evaluating a color parameter in an image depicting the fluid-containing matrix.

[0115] A third example provides a method according to the second example, wherein estimating blood loss comprises comparing a color parameter of at least a portion of the image to a template image to determine a concentration of a blood component associated with at least a portion of the fluid-containing matrix.

[0116] A fourth example provides the method according to the second example or the third example, wherein estimating blood loss includes using a parametric equation to determine a blood component concentration based on a color parameter.

[0117] A fifth example provides a method according to any one of the second to fourth examples, wherein the substrate is a fluid container.

[0118] A sixth example provides the method according to any one of the second to fifth examples, wherein the substrate is a surgical fabric.

[0119] A seventh example provides the method according to any one of the second to sixth examples, wherein estimating the patient's blood loss comprises detecting a weight of the fluid-containing matrix.

[0120] An eighth example provides the method according to the seventh example, wherein the substrate is a surgical fabric.

[0121] A ninth example provides the method according to the seventh example, wherein the substrate is a fluid container.

[0122] A tenth example provides the method according to any one of the first to ninth examples, wherein the blood loss protocol is a predetermined protocol for managing bleeding risk.

[0123] An eleventh example provides the method according to any one of the first to tenth examples, wherein the blood loss protocol is stored in one or more memory devices.

[0124] A twelfth example provides the method according to any of the first to thirteenth examples, wherein the blood loss protocol is customizable based on one or more user settings.

[0125] A thirteenth example provides the method according to the twelfth example, wherein the one or more user settings include one or more threshold blood loss values ​​associated with each of a plurality of patient phases of a blood loss protocol.

[0126] A fourteenth example provides the method according to any of the first to thirteenth examples, wherein determining the current patient stage comprises comparing the estimated patient blood loss to one or more threshold blood loss values.

[0127] A fifteenth example provides the method according to the fourteenth example, wherein the blood loss protocol includes a plurality of patient phases, and wherein at least one patient phase is associated with a lower threshold blood loss value and an upper threshold blood loss value.

[0128] A sixteenth example provides the method according to any one of the first to fifteenth examples, wherein the blood loss protocol includes a plurality of patient phases, wherein each patient phase includes one or more elements.

[0129] A seventeenth example provides the method according to the sixteenth example, wherein the one or more elements include a recommended action.

[0130] An eighteenth example provides the method according to the seventeenth example, wherein providing guidance to the user includes selecting one or more elements from a current patient phase of the blood loss protocol.

[0131] A nineteenth example provides the method according to the eighteenth example, wherein providing guidance further comprises displaying the one or more elements selected from the current patient phase of the protocol on the display.

[0132] A twentieth example provides the method according to the nineteenth example, wherein the display is on a mobile device.

[0133] A twenty-first example provides a method according to any one of the first to twentieth examples, wherein providing guidance to the user is also based on user input.

[0134] A twenty-second example provides a method according to any one of the first to twenty-first examples, further comprising providing updated guidance to the user.

[0135] A twenty-third example provides the method according to the twenty-second example, wherein the updated guidance is based on at least one user input.

[0136] A twenty-fourth example provides a method according to the twenty-third example, wherein the blood loss protocol includes multiple patient phases, and each patient phase includes one or more elements, and wherein providing updated guidance includes selecting one or more elements from the current patient phase of the protocol based on the at least one user input.

[0137] A twenty-fifth example provides the method according to the twenty-fourth example, wherein at least one element is conditionally selectable by the one or more processors to provide updated guidance.

[0138] A twenty-sixth example provides the 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.

[0139] A twenty-seventh example provides the method according to the twenty-sixth example, wherein the at least one user input comprises an indication by the user to perform one or more elements of a blood loss protocol.

[0140] A twenty-eighth example provides the method according to any of the twenty-second to twenty-seventh examples, further comprising determining an updated patient stage based on the updated blood loss estimate.

[0141] A twenty-ninth example provides the method according to the twenty-eighth example, wherein updated guidance provided to the user is based on the updated patient stage.

[0142] A thirtieth example provides a method according to the twenty-ninth example, wherein providing updated guidance is also based on at least one user input.

[0143] A thirty-first example provides the method according to any one of the twenty-second to thirtieth examples, wherein providing the updated guidance further comprises displaying the updated guidance on a display.

[0144] A thirty-second example provides the method according to any one of the first to thirty-first examples, further comprising displaying a notification associated with a current patient phase of the blood loss protocol on the display.

[0145] A thirty-third example provides a system for providing guidance during a medical procedure, the system comprising:

[0146] One or more processors configured to:

[0147] Estimate the patient's blood loss;

[0148] Determine the current patient phase of the blood loss protocol based on the estimated blood loss; and

[0149] Guidance is provided to the user based on the current patient stage of the blood loss protocol.

[0150] A thirty-fourth example provides the system according to the thirty-third example, wherein the blood loss protocol includes a plurality of patient phases, and wherein each patient phase includes one or more elements.

[0151] A thirty-fifth example provides the system according to the thirty-fourth example, wherein providing guidance to the user comprises selecting one or more elements from a current patient phase of the blood loss protocol.

[0152] A 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.

[0153] A thirty-seventh example provides a system according to the thirty-sixth example, wherein the updated guidance is based on user input.

[0154] A 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 an updated blood loss of the patient and determine an updated patient stage based on the updated estimated blood loss.

[0155] A thirty-ninth example provides the system according to the thirty-eighth example, wherein the updated guidance is based on the updated patient stage.

[0156] A fortieth example provides the system according to any one of the thirty-third to thirty-ninth examples, further comprising a display configured to display guidance to a user.

[0157] A forty-first example provides a method of providing guidance during a medical procedure, the method comprising:

[0158] At one or more processors:

[0159] Estimate the patient's medical parameters;

[0160] determining a current patient stage of a medical parameter protocol based on the estimated medical parameter; and

[0161] Guidance is provided to the user based on the current patient stage of the medical parameter protocol.

[0162] The forty-second example provides a method according to the forty-first example, 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.

[0163] A forty-third example provides a system for providing guidance during a medical procedure, the system comprising:

[0164] One or more processors configured to:

[0165] Estimate the patient's medical parameters;

[0166] determining a current patient stage of a medical parameter protocol based on the estimated medical parameter; and

[0167] Guidance is provided to the user based on the current patient stage of the medical parameter protocol.

[0168] The forty-fourth example provides a system according to the forty-third example, 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.

[0169] The forty-fifth example provides a carrier medium carrying machine-readable instructions, which are used to control a machine to perform the operations (e.g., method operations) performed in any one of the preceding examples.

[0170] The forty-sixth example 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 the machine, cause the machine to perform operations (e.g., method operations) specified by any one of the preceding examples.

Claims

1. A method comprising: estimating, by one or more processors of the machine, an amount of blood lost by the patient during the procedure; determining, 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 an estimated amount of blood lost by the patient during the procedure; determining whether a triggering event has occurred, the triggering event corresponding to a conditionally selectable element of the graphical representation of the guide corresponding to the determined current stage of the blood loss protocol; as well as The one or more processors of the machine cause a display to present a graphical representation of instructions corresponding to a current stage determined among the multiple stages of the blood loss protocol, determine whether a triggering event occurs, and further determine whether a corresponding conditionally selectable element is included in the instructions corresponding to the determined current stage of the blood loss protocol.

2. The method of claim 1, 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 presentation of guidance recommends performing an action from a set of recommended actions.

3. The method of claim 1, wherein: 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 to a range of blood loss values ​​that corresponds to the current stage of the blood loss protocol.

4. The method of claim 3, wherein: Multiple ranges of blood loss values ​​corresponding to the current stage of the blood loss protocol; and 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 the medical parameters of the patient.

5. The method of claim 3, wherein: Multiple ranges of blood loss values ​​corresponding to the current stage of the blood loss protocol; and 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 user input.

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

7. The method of claim 1, 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 presentation of the guidance indicates a recommended action selected from a set of recommended actions that can be performed on the patient.

8. The method of claim 1, wherein: The estimate 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 an updated estimate of the amount of blood lost by the patient; and Presentation of Guidance Updated guidance based on the updated determination of the current stage of the blood loss protocol is presented.

9. A system comprising: monitor; one or more processors; as well as A memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations including: Estimate the amount of blood the patient loses during the procedure; determining 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 an estimated amount of blood lost by the patient during the procedure; determining whether a triggering event has occurred, the triggering event corresponding to a conditionally selectable element of the graphical representation of the guide corresponding to the determined current stage of the blood loss protocol; and causing a display to present a graphical representation of instructions corresponding to a determined current stage among the plurality of stages of the blood loss protocol, determining whether a triggering event occurs further determines whether a corresponding conditionally selectable element is included in the instructions corresponding to the determined current stage of the blood loss protocol.

10. The system of 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 presentation of guidance recommends performing an action from a set of recommended actions.

11. The system of claim 9, wherein: 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 to a range of blood loss values ​​that corresponds to the current stage of the blood loss protocol.

12. The system of claim 11, wherein: Multiple ranges of blood loss values ​​corresponding to the current stage of the blood loss protocol; and 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 the medical parameters of the patient.

13. The system of claim 11, wherein: Multiple ranges of blood loss values ​​corresponding to the current stage of the blood loss protocol; and 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 user input.

14. The system of claim 9, wherein: The presentation of guidance indicates the current stage of the identified blood loss protocol.

15. The system of 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 presentation of the guidance indicates a recommended action selected from a set of recommended actions that can be performed on the patient.

16. The system of claim 9, wherein: The estimate 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 an updated estimate of the amount of blood lost by the patient; and Presentation of Guidance Updated guidance based on the updated determination of the current stage of the blood loss protocol is presented.

17. A machine-readable medium comprising instructions which, when executed by one or more processors of a machine, cause the machine to perform operations comprising: Estimate the amount of blood the patient loses during the procedure; determining 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 an estimated amount of blood lost by the patient during the procedure; determining whether a triggering event has occurred, the triggering event corresponding to a conditionally selectable element of the graphical representation of the guide corresponding to the determined current stage of the blood loss protocol; as well as causing a display to present a graphical representation of instructions corresponding to the determined current stage among the plurality of stages of the blood loss protocol, determining whether a triggering event occurs further determines whether a corresponding conditionally selectable element is included in the instructions corresponding to the determined current stage of the blood loss protocol.

18. The machine-readable medium of 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 presentation of guidance recommends performing an action from a set of recommended actions.

19. The machine-readable medium of claim 17, wherein: 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 to a range of blood loss values ​​that corresponds to the current stage of the blood loss protocol.

20. The machine-readable medium of claim 19, wherein: Multiple ranges of blood loss values ​​corresponding to the current stage of the blood loss protocol; and 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 the medical parameters of the patient.

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