OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care OBJECTIVE: To develop a novel robotic arm manipulator end-effector that attaches to robotic and autonomous systems to perform diagnostics and intervention medical tasks for combat casualty care. DESCRIPTION: The robotics industry has majorly advanced in the past few decades due to innovation in the ability to automate industrial and manufacturing tasks. This was focused on the design and function of robotic end-effectors to accomplish industrial tasks such as pick & place, lifting, and spot welding. Recent advancements in Artificial Intelligence (AI) and Machine Learning (ML) have opened the doors for Robotic and Autonomous Systems (RAS) to automate many more fields outside of manufacturing. Automation in the medical field is an emerging area, however it is primarily dominated by software based automated solutions. This is because physical interaction with robotic systems is limited to the functionality of the robotic end-effector, which have almost exclusively been developed for industrial and manufacturing purposes. Current robotic end-effectors rely on a two-finger configuration which is beneficial for simplicity and stability of rigid and structured objects. Additionally, the design of an end-effector is to fit a specific use case and not for general purpose use, limiting their ability to perform more than one task. As the Military Health System (MHS) is aiming to modernizing, it is looking to leverage emerging technologies to increase the capability and capacity of its medical care providers across the continuum of care [1,2]. The main issue remains that robotic end-effectors designed for industrial and manufacturing purposes will not be able to complete the complex and diverse set of tasks that are needed for automating aspects of combat casualty care. This topic calls for the development of novel robotic end-effector designs to specifically assist emerging robotic and autonomous solutions to medical tasks. The goal of the topic is to demonstrate the ability for the novel medically-focused robotic end-effectors to successfully perform a range of diagnostic and intervention patient care tasks. The focus of this SBIR topic is on the design and implementation of the robotic end-effector. Successful demonstration of patient care tasks may be fully teleoperated, as software autonomy is not being assessed, only the functionality of the hardware. This topic allows for any novel design of robotic end-effector and is not limiting to any specific type. In other words, rigid multi-fingered, soft robotics, and any other innovative design is welcome. General constraints to keep in mind are that the robotic end-effector should be safe and strong enough for physical interaction with a patient, such as lifting and repositioning an arm or a leg. The end-effector needs to be general purpose enough to interact and use many different medical objects such as those found in a medic's tool kit, and devices found in fixed hospitals. And lastly the end-effector needs to be dexterous and stable enough to use medical objects in completing various patient care diagnostics and intervention tasks. PHASE I: The goal of Phase I efforts is to provide evidence in the feasibility of the innovative end-effector design. In Phase I researchers should concentrate on software-based design and simulated capabilities of the proposed solution. Researchers will need to present their computer-aided design (CAD) drawings as well as their end-effector successfully performing patient care tasks in robotic simulation environments. It is suggested that performers should prove feasibility in their design accomplishing 3 of the following described prehospital medical tasks for both direct and in-direct human interaction. In-direct tasks include: 1) placing a pulse oximeter on a patient's finger, 2) assisting in a Bag-Valve Mask procedure by placing and holding the mask on the patient's face, 3) assisting in a Bag-Valve Mask procedure by continuously compressing the bag, and 4) lifting an ultrasound probe and maneuvering it across a patient's torso. Direct human interaction patient care tasks include: 5) lifting a patient's limb and repositioning it, 6) picking up a catheter and performing a Needle Decompression Thoracostomy, 7) picking up a scalpel and applying enough force and precision to perform the cutting steps of a Fasciotomy. In a feasibility proof-of-concept demonstration the performers should showcase their design's ability to perform 3 of these tasks in a digital simulation environment (e.g. Gazebo etc.). This effort is not concerned with the creation of high-fidelity digital patient assets and rudimentary digital shapes such as cylinders with similar sizes and weights can be substituted for human anatomy. PHASE II: In Phase II researchers should implement and fabricate the design demonstrated in Phase I's feasibility test. The goal at the end of Phase II is to have a physical robotic end-effector prototype capable of performing patient care procedures. The designed end-effector must be integrated onto an articulated robot arm platform. The choice of articulated arm platform is left to the researchers and can be either commercial-off-the-shelf or custom made (if previously developed, Phase II effort should not be spent on designing and building a custom articulated arm). Common articulated arms include but are not limited to Universal Robotics, Franka Emika, etc. At the conclusion of the Phase II effort the researchers must demonstrate the capability to teleoperate their robotic system (chosen articulated arm integrated with their novel end-effector) performing all seven of the patient care procedures described in the Phase I description. For the Phase II demonstration a manikin will be used in place of a patient and any representative manikin or medical task trainer will suffice to demonstrate the task completion. These tasks can be completed through teleoperation as there is not an expectation of autonomy in the execution of procedures. There is no need for any human subjects testing to demonstrate capability. The prototype system should be ruggedized enough to operate outdoors (i.e., closed prototype with no loose wires or breadboards). Applicants should describe their approach to the regulatory requirements and describe their strategy to obtain clearance / approval for the end product. Phase II topic proposals should include a strategy on how to obtain regulatory/FDA approval. It could be beneficial to target existing FDA approved medical robotic platforms for prototype end-effector integration for future Phase III efforts into commercialization and regulatory approval. PHASE III DUAL USE APPLICATIONS: In Phase III the focus should be on interoperability and commercialization for Government and civilian use. If the intention of commercialization is for medical purposes, then the goal of Phase III efforts should be to obtain regulatory/FDA approval of the developed device. Phase III provides an opportunity for additional improvements to the system that enable commercialization and for regulatory approval. These include improvements to make the end-effector more compatible with the most widely used commercial and Government used robotic platforms. Additionally Phase III can allow for additional ruggedization of the prototype to enable better use in outdoor and military domains. Phase III is also an opportunity to look beyond the prescribed seven tasks in Phase II and develop additional capabilities for the novel end-effector, including investigating adding autonomy features. For consideration of Government commercialization, the end-effector should target capabilities of accomplishing robotic-assisted diagnostic and intervention tasks in the battlefield prehospital setting as well as fixed hospital care. This includes the ability to perform patient care tasks for tactical combat casualty care, prolonged field care, and care within evacuation vehicles. In the civilian sector there are many paths for commercial use of the developed end-effector. Similar to the Government sector, evacuation care in the civilian sector could utilize the novel medical end-effector for use in en-route care, specifically in long medical transfers. Rural medical facilities are particularly under resourced in both personnel and specific expertise and could benefit from the use of autonomous or teleoperated robotic systems for various diagnostic and medical interventions. Additionally centers for elderly care and 24/7 assisted living could also benefit from autonomous and robotic systems treating and administering care to their patients beyond the capabilities of today's robotic capabilities. REFERENCES: United States Army Futures Command Concept for Medical 2028, https://api.army.mil/e2/c/downloads/2022/04/25/ac4ef855/medical-concept-2028-final-unclas.pdf United States Army Medical Modernization Strategy, https://www.army.mil/e2/downloads/rv7/about/2022_Army_Medical_Modernization_Strategy.pdf KEYWORDS: Robotics, End-Effector, Medical, Prehospital, Combat Casualty Care, Automation, Innovation, Modernization
