Battlefield medical treatment has advanced tremendously in recent years, exemplified by the development of Tactical Combat Casualty Care (TCCC), which emphasizes immediate attention to life-threatening conditions, such as airway blockage or fatal bleeding. Advances in practice and technology, such as QuikClot Combat Gauze™ and traditional tourniquets on limbs, have prevented many combat-related deaths.
Unfortunately, certain injuries, such as non-compressible hemorrhages in junctional or inguinal areas (such as pelvis, groin, underarms, or neck), cannot be addressed by these techniques. Inventors have developed new types of junctional tourniquets, also referred to as junctional tourniquet devices, to respond to this challenge. Examples of junctional tourniquet devices include the Abdominal Aortic Junctional Tourniquet (“AAJT”), the SAM Junctional Tourniquet (“SJT”), the Junctional Emergency Treatment Tool (“JETT”), and the Combat Ready Clamp (“CRoC”), which address abdominal and pelvic injuries.
While these hemorrhage-control technologies have been validated and approved for use by the FDA, as well as accepted into the TCCC guidelines, training systems for these technologies have not been fully realized.
Traditional methods of teaching use of tourniquets include practicing placing the tourniquet on a live human (providing no objective metrics, and cannot use full pressure); practicing placing the tourniquet on an animal (providing no objective metrics, are costly, and may raise ethical questions); and, practicing placing the tourniquet on a manikin (proving no objective metrics, and no feedback on performance).
An aspect of the present disclosure is directed to systems and methods providing a combination of sensors and software to enhance the process of learning how to apply a junctional tourniquet to non-compressible hemorrhages, using a separate force sensing system, providing detailed feedback on the physical process of how the tourniquet was applied, and offering novel flexibility in application and sensing.
These, as well as other components, steps, features, objects, benefits, and advantages, will now become clear from a review of the following detailed description of illustrative embodiments, the accompanying drawings, and the claims.
The drawings are of illustrative embodiments. They do not illustrate all embodiments. Other embodiments may be used in addition or instead. Details that may be apparent or unnecessary may be omitted to save space or for more effective illustration. Some embodiments may be practiced with additional components or steps and/or without all of the components or steps that are illustrated. When the same numeral appears in different drawings, it refers to the same or like components or steps,
Illustrative embodiments are now described. Other embodiments may be used in addition or instead. Details that may be apparent or unnecessary may be omitted to save space or for a more effective presentation. Some embodiments may be practiced with additional components or steps and/or without all of the components or steps that are described.
An aspect of the present disclosure provides or uses a combination of sensors and software as a tourniquet master training (“TMT”) system, process, and/or algorithm to enhance a process of learning how to apply a junctional tourniquet to non-compressible hemorrhages. A force sensing system is preferably employed, which provides detailed feedback on the physical process of how the tourniquet was or is being applied, and accordingly offering novel flexibility in application and sensing.
Embodiments of the present disclosure provide a sensor-based TMT system usable with a variety of manikins and application areas. Exemplary embodiments of the present disclosure include a TMT system providing scenario-based training featuring (1) a reconfigurable sensor system linked to a software-based virtual mentor (or tutor) that provides objective assessment during training, and (2) a mobile mentor (or, tutor) that provides refresher training. Because of the flexibility provided, TMT systems can be very affordable and also configurable for future advances, including new application areas (e.g., axillary applications) for both existing and future devices.
With continued reference to
The sensor pad 102 detects the force applied by a tourniquet JT on a simulated wound and its signals are used by the assessment module 104 and/or instructor assessment software no to discriminate between different placements (e.g., on the manikin) of the tourniquet. Other optional data that the sensor pad 102 may additionally capture include the absolute position of the sensor system (such as through GPS) or temporal data. Exemplary versions of the sensor pad 102 may include additional anatomical representations such as simulated belly fat and/or bones or portions of bones (e.g., a sagittal crest), or other anatomical “landmarks.”
An exemplary embodiment of the sensor pad 102 includes a sheet of acrylonitrile butadiene styrene (“ABS”) plastic with a matrix of force-sensing sensors adhered to (positioned on) the top of it, with a layer of silicon rubber containing a marble adhered on top of that. In exemplary embodiments force-sensing sensors are preferably force-sensing resistors (“FSR”). In some embodiments, an Interlink Electronics FSR 406 model of force sensing resistor may be used for the force sensor(s). Another embodiment of the sensor pad includes a sheet of paper with multiple individual FSR sensors taped on top, with a layer of silicon rubber placed loosely on top of that. In another embodiment, four Sensitronics ShuntMode Matrix Array sensors are used, and these are encased on all sides by silicone rubber (i.e., they do not rest on a plastic surface). In yet another embodiment, two Kitronyx MP2508 10×16 FSR Matrix sensors are used, connected to a flexible printed circuit board (PCB), all of which are encased in the silicon rubber. The sensor pad 102 is preferably connected to the assessment module 104 in order to transmit its data to the assessment module 104. This connection can be one or more wires, or it can be a wireless mechanism, e.g., Bluetooth, XBee, or the like. In exemplary embodiments, a sensor pad 102 used individual 1.5″×1.5″ Interlink force sensing resistors adhered to a sheet of paper. In alternate embodiments, a sensor pad 102 can use a single printed pad containing multiple sensors inside of it for more precise measurements and reduced risk of damage.
The assessment module 104 preferably either stores all data produced by the sensor pad 102 or transmits the data to the instructor assessment software 110 so that it may store the data. One of either the assessment module 104 or the instructor assessment software 110 preferably computes metrics on the data coming from the sensor pad 102, depending on the specific embodiment. These metrics can include (but are not limited to) the elapsed time, the pressure exerted on the pad, and the center of mass of objects placed on top of the pad.
The assessment module 104 may optionally include a display, e.g., for indicating when data is being recorded and when pressure exerted on the pad is high enough to stop a simulated bleed. In one embodiment, the assessment module 104 is an Arduino Leonardo with an LCD screen, button matrix, SD disk writer, USB port, and power supply. Another embodiment of the Assessment Module is a commercial data acquisition device serving as an intermediary between the Sensor Pad and the instructor assessment software no. In another embodiment, the assessment module is a Samsung Galaxy Active Tab 2 with custom software deployed onto it. The assessment module 104 is preferably connected to the instructor assessment software no in order to transmit its data to the instructor assessment software no. This connection can be one or more wires, or it can be a wireless mechanism such as Bluetooth, XBee, or the like.
The instructor assessment software no preferably produces logs and summaries of the data and metrics. In an exemplary embodiment, the instructor assessment software 110 is a Java desktop application computing metrics, presenting data summaries, and producing logs.
The live feedback display 106 preferably visualizes the placement of objects on top of the sensor pad 102 and updates in real time. The live feedback display 106 preferably visualizes the location, amount of pressure exerted, and elapsed time. The live feedback display 106 may also visualize steps in the sequence of actions required to place the object, e.g., junctional tourniquet JT.
In exemplary embodiments, the live feedback display is or includes a mobile application on a mobile device such as a “cell” phone. In other embodiments, the live feedback display can be a window (e.g., a dedicated or separate window) within a user interface (e.g., display screen) used for or with the instructor assessment software no. The live feedback display 106 preferably either connects to the instructor assessment software 110 or to the assessment module 104, whichever is computing metrics on the placement of objects on the Sensor Pad. This connection can be either wired or wireless. The Mobile Mentor preferably presents didactic instruction, quizzes, and supporting media to train the placement of a specific object on the sensor pad. One specific embodiment of the Mobile Mentor is a mobile phone application with a sequence of screens providing instruction on how to place a junctional tourniquet.
The Supporting Instructional Materials (not shown) can provide the same type of content as the Mobile Mentor but may be present in a different format, e.g., including paper, and/or depth of detail or extent of subject matter coverage.
In exemplary embodiments, a TMT sensor setup may include different numbers and configurations of resistors, e.g., 8 FSR 406 force sensing resistors; the resistors can send data to a green printed circuit board (PCB) via reinforced wires; the PCB may connects directly into a data acquisition unit, e.g., a National Instruments DAQ.
Virtual mentor 750 can include a feedback display 760, and receive as inputs sensor data 752 and click data 754, as non-limiting examples, and these may be combined as joint training instance (“TI”) data 756. The TI data 756 may be logged or recorded by a TI data log 796. The virtual mentor 750 may receive other types of inputs in other embodiments of the present disclosure. The feedback display 760 can include or present a display related to the Gold standard 770 and/or a display of data from the trainee's actions, as indicated by “Trainee Run” 780. The Gold Standard display 770 can present time to complete 772, current pressure 774, display(s) of steps 776, and graphs of pressure 778. Similarly, the Training Run display 780 can present time to complete 782, current pressure 784, display(s) of steps 786, and graphs of pressure 788.
As shown at left, a gold standard performance can be established, as indicated at 720. For this, an instructor 3 can indicate a start of the procedure, e.g., by activating a user input mechanism such as pressing a “begin” button or switch or the like 722. The instructor 3 can then apply a given tourniquet device, e.g., an AAJT, CRoC, or the like to the stand-in manikin 710, as indicated at 724. When finished, the instructor 3 can then indicate completion of the tourniquet application 726, e.g., by activating a user input mechanism such as pressing a completed button, switch, or the like. The system, e.g., system 100 of
With continued reference to
In exemplary embodiments, a participant setup screen can be provided by or for the TMT virtual mentor software; this screen can be used to collect information which allows performance data to be linked to specific users.
In exemplary embodiments, a trial setup screen can be provided by or for the TMT software; the instructor can indicate the type of tourniquet, the required pressure, trial, and the amount of time the trainee has to complete the application.
In exemplary embodiments, an alternate feedback display can be provided by or for the TMT virtual mentor, which shows sensor data numerically rather than visually; this screen may be well-suited for use by developers.
In alternate embodiments, a screen for calibrating an AAJT in a TMT virtual mentor, other numbers and configurations of pressure templates can be specified, e.g., 3 rows by 3 columns for a total of 9 templates, etc. The correct index can be selected by the instructor.
In exemplary embodiments, an instructor control panel can be used for a TMT virtual mentor. Such a control panel can allow the instructor to control and/or indicate progression during the training exercise. For example, the instructor can indicate a trainee progressing through required trial tasks or steps by marking those tasks or steps off by pushing the buttons on the display. Examples of such trial tasks include, but are not limited to, “removed CRoC from bag,” “raised baseplate arm,” “Attached vertical arm,” “attached horizontal arm,” “Attached T handle,” “Attached disk,” “Positioned baseplate,” “Adjusted device arm(s),” “Positioned CRoC,” “Applied pressure,” “Buckled belt,” and “Tightened belt,” as non-limiting examples; other trial tasks may be indicated. That feedback can be passed to the trainee display.
In exemplary embodiments, an after-action review (AAR) screen may be provided by a virtual mentor. This screen can be used to provide a summary of trainee performance after completing training. For example, portions of such a screen can provide information may be about the trainee and training session, a summary of performance on the critical metrics, and a detailed timeline of events during the session, as non-limiting examples.
In exemplary embodiments, of a sensor configuration screen can be provided by a TMT virtual mentor. This can be used to allow instructors to define the placement of sensors on the manikin, including their relative position and orientation, their size, and the spacing between them. In exemplary embodiments, a setup page can be used for or provided by the TMT virtual mentor, which can show an overview of the configuration data currently being used.
In exemplary embodiments, a mobile mentor, e.g., an AAJT mobile mentor can include or provide quiz pages. For example, one or more quiz pages can include questions that require the trainee to select the appropriate location for applying the tourniquet, testing their decision-making skills. A quiz page may include one or more figures that serve to assess the trainee's declarative knowledge of the steps of applying a tourniquet, e.g., a AAJT, such as by requiring the trainee to identify a missing step. One or more figures may facilitate assessment of a trainee's procedural knowledge by requiring the trainee to place the steps in the correct order. An exemplary embodiment of the mobile mentor may be built using the “Declarative to Procedural 2.0” (D2P2) web tutoring framework, or similar frameworks such as GuideView or the Generalize Intelligent Framework for Tutoring (GIFT).
In exemplary embodiments, a high-level editor can be used for creating and organizing pages in the tutor (mobile mentor), e.g., a D2P2 high level editor. In exemplary embodiments, an authoring tool, e.g., a GuideView authoring tool, can be used to lay or design out tutors (or tutorials) in the form of branching flowcharts. In exemplary embodiments, a page at the beginning of an AAJT mobile mentor can provide information about the tutor or mobile mentor itself. In exemplary embodiments, a concepts and skills overview page can be used for or provided by the AAJT mobile mentor. In exemplary embodiments, a quiz page may ask a trainee to correctly match the name of a part of a tourniquet, e.g., a AAJT, to text (e.g., a letter or number) labeling that part. In exemplary embodiments, a virtual patient trauma simulation can be used to facilitate training. For example, a user can interact with a virtual patient by selecting various tools and actions to use on the patient. The user can also observe various physiology properties of the patient, such as by palpating or inspecting various body regions or by applying a pulse oximeter.
Training can include the use of wireframe of similar graphics. In exemplary embodiments, for example, two wireframes shown with junctional tourniquets can be displayed for a trainer to show how a junctional hemorrhage scenario could be implemented in a trauma simulation; this may facilitate the training of cognitive and decision-making skills for junctional tourniquets. For example, a user (trainee) would interpret physiological data and wound location to determine whether a junctional tourniquet is appropriate, which one to use, and where to place it. This scenario assesses their knowledge of the indications and contraindications for use of the various tourniquets. A could be tasked with selecting the correct steps for applying the AAJT, and perform them in the right order and in an appropriate amount of time. Such scenarios may be used to assess declarative knowledge about the steps and parts of the AAJT (or similar JT).
In exemplary embodiments, a Kitronyx Snowboard microprocessor may be used for an assessment module, e.g., 104 of
Exemplary embodiments were tested for sensor sensitivity, with an assessment being made of the changes in readings on the Sensitronics ShuntMode sensor as a result of additional presses on the hand pump, starting with an SJT that is fully tightened and secured over the sensors. In testing, it was shown that the sensors can clearly detect when the bottom of the SJT changes shape due to inflation (the SJT bladder includes a series of rings at the bottom which extend at different points depending on the amount of inflation).
In exemplary embodiments, instead of a breadboard, wires can be connected to both sensor interfaces on the Snowboard microcontroller. This is so that both interfaces can be observed when designing and building the enclosure. During use, each assessment module can preferably be connected to only a single sensor pad.
In exemplary embodiments of an assessment module and its electrical components, a standard SanDisk writer can be used for data logging. In other embodiments, a modified SanDisk writer can be used, which includes a GPS tracker and has the ability to log GPS coordinates.
In exemplary embodiments, a Hammond Arduino project enclosure can be used and modified to enclose an assessment module. This is a COTS enclosure from Hammond Manufacturing. This rugged enclosure best matches the dimensions of the Assessment Module parts when they are arranged compactly. This enclosure can be modified simply with a power drill in order to add holes for the buttons and screen and for the ports for the sensors, USB port, and battery pack.
In exemplary embodiments, one or more interaction-level “Exercises and Data” screen can be used in the instructor assessment station desktop software application. This screen can allow the instructor to view data from a particular exercise or group of trainees. When the instructor selects a particular exercise or listed group of trainees, the “View Data” button can be activated. For further example, when the “View Data” button is clicked, a new window can be caused to appear prompting the instructor for the type of data they'd like to view. In this case, they can view background info, raw sensor data, and timelines of training events for a particular exercise or group of trainees. As another example of an interaction-level screen, an “Add Record” window can be provided within the “Individual Trainees” screen in the Instructor Assessment Station software application. This screen can allow instructors to add new trainees and fill in data for that new trainee by entering text in a set of labeled text boxes. Interaction-level screens or windows can be used for the “Add Record” window within the “Individual Trainees” screen in the Instructor Assessment Station software application. Using such a screen or window, instructors can modify the data structure using the “Add Field” button, which populates records with an entirely new field. In exemplary embodiments, a “Home screen” for the instructor assessment station software, instructors may be provided access to data on their trainees, classes, and TMT devices. Instructors may be allowed to and provided with the ability to define fields for information they consider relevant to store about their trainees. A search bar can be used to allow them to filter records based criteria within the fields. A window can be provided for editing individual trainee data or creating new records for trainees.
In exemplary embodiments, a window for viewing data on groups that the instructors are responsible for. Groups can be organized according to the instructor's preference, so they can represent individual classes, military units, etc. In exemplary embodiments, a window can be provided for viewing and editing metadata on groups. This data includes individuals that are members of the group, exercises that the group has participated, and other descriptive information such as the group's leader, location, and description. As with the fields in the records for individual trainees, instructors have the freedom to define fields that they think are relevant.
In exemplary embodiments, an assessment module can includes a touch screen rather than text screen. Users can select to begin training or to manage the data that is logged during training. In exemplary embodiments, an assessment module includes a configuration process prior to training in which the instructor can set several parameters about training. This screen lets them select which tourniquet will be used with the system. In exemplary embodiments, a set of screens from an assessment module configuration process can allow instructors to set the thresholds for the minimum amount of pressure to stop bleeding and the maximum amount of pressure beyond which the tourniquet will cause additional injury. In exemplary embodiments, a screen from the configuration process for an assessment module can allow instructors to set the difficulty level of the training. For example, an easy scenario may reach a steady state once the tourniquet is applied, while a difficult scenario may cause “re-bleeding” to simulate vascular movement, or as a result of air transport. In exemplary embodiments, a data management screen of an assessment module can allow instructors to either delete data files or transfer them to a computer.
Accordingly, relative to previous techniques, embodiments of the present disclosure afford benefits and/or key distinguishing features, including (but not limited to) metrics on placement of a tourniquet over its target location is computed automatically and objectively (e.g. with respect to pre-defined metrics)—feedback on placement is then available to be presented in real time or another time. Training systems, methods, and components such as described above for embodiments of the present disclosure, which can be used to teach and refresh skills for the described types hemorrhaging injuries (in particular, non-compressible hemorrhages in junctional or inguinal areas), may be particularly useful or vital because such injuries are rare on the battlefield and difficult to train for.
In preferred embodiments, embodiments can utilize force sensing technology as described, i.e. force sensing resistors. In other embodiments, other force sensing technology may be used, e.g., capacitive touch sensors, inductive touch sensors, or the like.
In some exemplary embodiments, different specific physical prototypes have used the following components; these are merely given by way of examples and other suitable components may be used within the scope of the present disclosure:
Sensor Pad: Interlink FSR 406, Sensitronics ShuntMode array, Sensitronics ThruMode array, Kitronyx matrix sensor 1007, Kitronyx matrix sensor 1610, Smooth-on Ecoflex 00-30, Smooth-on Slacker, generic marbles, Digikey jumper cables, TAP Plastics ABS sheet;
Assessment module: Kitronyx Snowboard 1, Adafruit LCD displays (various models), Adafruit button matrix (various models), Crystalfontz LCD displays (various models), Sparkfun GPS shield, Sparkfun SD shield, Digikey battery clips, batteries (various brands), National Instruments NI-USB 6210, C++;
Live feedback display: JAVA, Apache ActiveMQ, Python, C++;
Instructor Assessment Software: C++; and
Mobile Mentor: Penn D2P2.
Unless otherwise indicated, the systems and components that have been discussed herein, e.g., shown and described for
Each computer system may be a desktop computer or a portable computer, such as a laptop computer, a notebook computer, a tablet computer, a PDA, a smartphone, or part of a larger system, such a vehicle, appliance, and/or telephone system.
A single computer system may be shared by the systems and components that have been discussed herein, e.g., shown and described for
Each computer system may include software (e.g., one or more operating systems, device drivers, application programs, and/or communication programs). When software is included, the software includes programming instructions and may include associated data and libraries. When included, the programming instructions are configured to implement one or more algorithms that implement one or more of the functions of the computer system, as recited herein. The description of each function that is performed by each computer system also constitutes a description of the algorithm(s) that performs that function.
The software may be stored on or in one or more non-transitory, tangible storage devices, such as one or more hard disk drives, CDs, DVDs, and/or flash memories. The software may be in source code and/or object code format. Associated data may be stored in any type of volatile and/or non-volatile memory. The software may be loaded into a non-transitory memory and executed by one or more processors.
The components, steps, features, objects, benefits, and advantages that have been discussed are merely illustrative. None of them, or the discussions relating to them, are intended to limit the scope of protection in any way. Numerous other embodiments are also contemplated. These include embodiments that have fewer, additional, and/or different components, steps, features, objects, benefits, and/or advantages. These also include embodiments in which the components and/or steps are arranged and/or ordered differently.
Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. Further, use of the terms “preferable” or “preferably” does not mean that something is absolutely necessary or required.
All articles, patents, patent applications, and other publications that have been cited in this disclosure are incorporated herein by reference.
The phrase “means for” when used in a claim is intended to and should be interpreted to embrace the corresponding structures and materials that have been described and their equivalents. Similarly, the phrase “step for” when used in a claim is intended to and should be interpreted to embrace the corresponding acts that have been described and their equivalents. The absence of these phrases from a claim means that the claim is not intended to and should not be interpreted to be limited to these corresponding structures, materials, or acts, or to their equivalents.
The scope of protection is limited solely by the claims that now follow. That scope is intended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows, except where specific meanings have been set forth, and to encompass all structural and functional equivalents.
Relational terms such as “first” and “second” and the like may be used solely to distinguish one entity or action from another, without necessarily requiring or implying any actual relationship or order between them. The terms “comprises,” “comprising,” and any other variation thereof when used in connection with a list of elements in the specification or claims are intended to indicate that the list is not exclusive and that other elements may be included. Similarly, an element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional elements of the identical type.
None of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 101, 102, or 103 of the Patent Act, nor should they be interpreted in such a way. Except as just stated in this paragraph, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.
The abstract is provided to help the reader quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, various features in the foregoing detailed description are grouped together in various embodiments to streamline the disclosure. This method of disclosure should not be interpreted as requiring claimed embodiments to require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.
This application is based upon and claims priority to U.S. provisional patent application 62/687,491, entitled “Training System for Tourniquet Application,” filed 20 Jun. 2018, attorney docket number 243012-0017R; the entire content of this noted provisional application is incorporated herein by reference.
This invention was made with government support under contract numbers Wx81XWH-17-C-0098 and W81XWH-13-C-0021 awarded by U.S. Army Medical Research and Material Command. The government has certain rights in the invention.
Number | Date | Country | |
---|---|---|---|
62687491 | Jun 2018 | US |