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Development of a Portable Platelet Apheresis Machine
Navy SBIR 2016.1 - Topic N161-064 ONR - Ms. Lore-Anne Ponirakis - [email protected] Opens: January 11, 2016 - Closes: February 17, 2016 N161-064 TITLE: Development of a Portable Platelet Apheresis Machine TECHNOLOGY AREA(S): Biomedical ACQUISITION PROGRAM: MARCORSYSCOM; PM-CSS PdM - Combat Support Equipment, Biomedical Engineering OBJECTIVE: Development of a single-person carry, ruggedized, battery operated, automatic platelet apheresis device to provide fresh, leukocyte-reduced, platelets in the field. DESCRIPTION: Platelets are a blood component essential to hemorrhage control. The majority of preventable deaths on the battlefield are secondary to hemorrhage. Survivability is inversely related to the speed of receiving blood/blood components following catastrophic wounding. Transfusion of whole blood is not realistic in the expeditionary environment due to whole blood storage requirements and removal of substantial intravascular volume causes the donor to be temporarily "out of the fight". To overcome this, naval medical facilities have components of whole blood except platelets which have a very short shelf life. Currently manufactured platelet apheresis devices exist in transfusion centers but are not designed for expeditionary use (being large, heavy, bulky and have external components susceptible to breakage) with the process taking 60-120 minutes to be complete. Determination of lab values (blood type, human leukocyte antigens s, donor sepsis, platelet count, etc.) occurs as separate steps. A solution is the development of a portable, automated, platelet apheresis machine (apheresis removes platelets while returning all other blood cells and plasma to the donor). Field apheresis will allow platelets to be collected from a single donor on site so they are available to the severely injured. Required Features: � The device must be able to receive and maintain the donor�s personal info for tracking, and be able to print all stored data. � Automated laboratory assays to determine blood type, platelet number and serum calcium levels; results displayed on electronic screen. � Simple operation. For example, after obtaining and presenting the data, the device prompts the administrator with the question "Do you want to proceed with apheresis?" With the push of the "yes" button, platelet collection begins. Performance of the device must be equivalent to currently FDA approved devices. It must be lightweight, ruggedized, have an effective platelet separation and leukoreduction processes, have automated features (blood pressure cuff, saline infusion, process cycles, etc), reduced need for citrate (an anticoagulant typically used in the blood collection process), simple operation and set up. The device needs to be able to determine hematocrit and platelet count prior to initiation of apheresis cycle and be able to optimize device settings based results and entered patient data (sex, height, weight). Must be FDA approved on completion. PHASE I: Determine technical feasibility of an approach and develop the concept technology for a portable platelet apheresis device. Device must be a closed-system (to maintain sterility) able to sequester and concentrate platelets while returning all other blood components to the donor. Device must also specifically reduce, to the greatest extent possible, immunogenic leukocytes (leukoreduced). Device should also perform laboratory assays as part of the process: determine blood type, donor�s platelet count and calcium levels. Deliverable would be a design schematic and analysis of potential technical and regulatory issues. PHASE II: Select the best approach from Phase I to develop and demonstrate a prototype device (End of Phase II deliverable). The prototype will be used to establish, through experiments and prototype fabrication, performance parameters of the device. Phase II milestones: � Initial Planning Meeting/Design Review � Demonstration of personal data input/output � Demonstration of laboratory assays, data acquisition, output on electronic display (graphical user interface or GUI), storage and print ability � Demonstration of closed processing system incorporating leuko-reduction and platelet sequestration & concentration � Demonstration of packaging system PHASE III DUAL USE APPLICATIONS: Phase III work is oriented towards commercialization with planned transition to the Rapid Innovation Fund program to complete hardware design and manufacture and development of required documents to enter into Food and Drug Administration (FDA) approval path. The ramp-up to manufacturing and the commercialization plan will also be developed during this phase of development. Developing countries or rural areas in developed countries where access to blood products is limited due to distance or lack of capabilities to store and maintain perishable blood products. May also have appeal to NGO�s involved in disaster relief efforts where existing blood supplies are rapidly depleted or conditions for storage of blood products do not exist. REFERENCES: 1. Transfusion Medicine and Hemostasis. Shaz BH, Hillyer CD, Roshal M and Abrams CS, 2nd Edition, Elsevier, 2013. 2. McLeod BC: Apheresis, Principles and Practice. 3rd Edition, AABB Press, 2010. 3. Apheresis: Basic Principles, Practical Considerations and Clinical Applications, retrieved from http://pathology.ucla.edu/workfiles/Education/Transfusion%20Medicine/13-5-Apheresis-Basic-Principles-Practical-Considerations-and-Clinical-Applications-part KEYWORDS: Platelets, Apheresis, Leuko-reduced, Portable, hemorrhage control, blood components; massive transfusion TPOC-1: Michael Given Email: [email protected] TPOC-2: Tara Zieber Email: [email protected] Questions may also be submitted through DoD SBIR/STTR SITIS website.
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