The current processes for blood collection and transfusion are complex and labor-intensive with real-time decision-making presently executed by numerous skilled medical professionals and varied systems and technologies, and prone to human error. Data from Combat Training Centers (CTC) demonstrate that less than a 60% success rate at WB transfusion and that the average time from initiating a walking blood bank to completing the transfusion of one unit of blood is over 40 minutes. This data is also obtained without significant duress for the trainees – no patient is dying and there is not actual risk to the medical providers (i.e., no actual indirect or direct fire). Multiple factors contribute to this including the identification of suitable veins for venipuncture, to ensuring accurate typing and crossmatching of blood, to the physical requirements of priming IV tubing, agitating the blood collection bag, maintaining gravity for drainage… each step presents opportunities for mistakes that at best risk lost units of blood (and lost donors) and at worst have life-threatening consequences. These outcomes and considerations highlight the intrinsically complex difficulties of the process and greater impact to expected outcomes in Department of War (DoW) workflows with and for its warfighters.This SBIR topic seeks innovative proposals for a single, integrated device that addresses these challenges through complete automation and continuous monitoring of both the donor and recipient. The device should be easily applicable to a wide range of patient sizes and ages and must autonomously collect blood (assess adequacy of vascular access and provide pump action, real-time mixing of citrate anticoagulant to ensure each drop of blood is usable in the event of a “short” donation, continuous unit agitation), type and screen the donated blood, type and crossmatch the recipient to ensure viability for donation, and transfuse blood with heated circuit. Additional options include: pressure transfusion to rapidly transfuse blood, direct donor-to-recipient transfusion, up-to-double unit collection from a single donor, autonomous venipuncture for other procedures requiring vascular access, blood unit extraction for other uses. All equipment to perform all functions are housed within the device and there is absolutely no need to access or manipulate anything. In configuration one, attach the device IV tubing to the donor’s IV (and/or the recipients IV) and push “go.” In configuration 2, place the device on the respective donors or recipients for venous access and push “go.” The device should also incorporate cost permissive non-invasive sensors to continuously monitor donor and recipient vital signs (e.g., HR, SpO2, respirations, blood pressure, temperature). The device must be programmed to recognize abnormal vital sign patterns or other concerning indications of a blood transfusion reaction and automatically alert medical personnel. The goal is to create a self-contained unit that can be applied to a blood donor or recipient and, with minimal human intervention, perform all necessary steps for safe and effective blood collection and transfusion. The continuous monitoring and alert system will further enhance safety by providing an early warning of potential adverse events. This will reduce variability and errors, increase precision and reproducibility, enhance efficiency and efficacy, eliminate the need to manage individual equipment elements, and free up medical personnel for other critical activities. The proposed device should integrate and miniaturize existing technologies, incorporating robust sensors, AI-driven decision logic, and secure data connectivity. The device must meet stringent safety and reliability standards, with built-in fail-safes and comprehensive monitoring capabilities. The device should also be ruggedized for use in austere environments. Successful proposals will demonstrate a clear path toward a deployable prototype that can significantly improve blood transfusion services in both military and civilian settings. Target cost for such a device should be less than $300 at market price, weigh less than 5 lbs when empty, be rugged enough to drop from a standing height, and be designed to fit in a “golden hour cooler” if the blood will not be used immediately and to be discarded after transfusion is complete.The devices must include end-to-end automation of the process and anticipate a single product submission for FDA approval. The essential steps to automate (and integrate) include:1. Vascular access (placement of IV catheter in patient).2. Miniaturization of automated vascular access.3. Human hooks donor/recipient up IV tubing to IV/IO.4. Assessment of the suitability for drainage of a placed vascular access (IV or IO).5. Assessment of donor blood type.6. Infectious disease screen.7. Infusion of appropriate amount of anticoagulant (citrate) in real-time (avoids problem of underfilling).8. Agitation.9. Stoppage when bag is “full” (avoids problem of overfilling and over collecting in the event that donation and transfusion are synchronous).10. *Individual must remove and reset/connect the device to recipient11. Assessment of recipient blood type (by finger/skin prick, no IV/IO required) - synchronous or asynchronous execution.12. Assessment of recipient vascular access - synchronous or asynchronous execution.13. Determine Whether to Initiate Transfusion ALLOWS TRANFUSION ONLY AFTER CONDITIONS MET (matching blood type, access sufficient) – avoids anaphylaxis, lost time, lost blood.14. Transfuses blood on pump (faster than by gravity).15. Transfuses calcium after blood transfusion complete to reverse anticoagulant effect of citrate (optional).16. Report successful completion of procedure.17. Secure or Discontinue IV catheter.
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