KS MANUFACTURING INC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Innovative platelet storage container is developed to prevent bacterial growth in the stored platelets at blood centers The new container fulfils blood bank needs in safely storing platelets collected from donors for more than days at room temperature The container is built with natural materials that have the characteristics in capturing and killing bacteria without involving any drugs chemicals or radiations The stored platelets are isolated from the natural material therefore their medical qualities are not compromised and their safety is not affected Initial prototypes of the container were built by the development team The prototypes were tested by an outside lab for proof of concept Initial results indicated the effectiveness of the new container in eliminating inoculated Staphylococcus Aureus bacterial contamination in days and in days of storage with encouraging platelet count results This study aims to expand on proof of concept testing and to verify the effectiveness of the new container in eliminating four species of the most fatal bacteria Staphylococcus Epidermidis Staphylococcus Aureus Pseudomonas Aeruginosa and Serratia Marcescens without compromising platelet quality PUBLIC HEALTH RELEVANCE Platelet transfusion therapy has been increasingly used in medical application worldwide Platelets are collected from normal donors Single Donor Platelets SDP or derived from collected whole blood WBDP Blood centers have to store collected platelets units at room temperature in order to preserve its functionality post transfusion Bacterial contamination of blood components has been a relentless predicament since the establishment of transfusion medicine Bacterial contamination of platelet units represents the largest infectious disease risk in transfusion medicine with an estimated incidence of to units collected Many attempts were made to eliminate bacteria from the stored platelet solution But all the methods required mixing the platelets with different chemicals and exposing it to radiation These methods required special equipment with elaborated procedures that made it practically difficult and financially stressful on blood centers The proposed storage container is built with natural material that has inherent characteristics in trapping and killing bacteria and viruses The stored platelets are separated from the natural material and do not contact it at any time during storage therefore preserving the quality and the integrity of the stored platelets The platelet concentrate are not mixed with any chemical solution or exposed to any radiation of any sort This natural material does not dissolve in blood plasma or other additive solutions The physical and chemical characteristics of the new container the shape and the fit are identical to the currently used platelet containers in the blood bank industry Blood bank operations for platelet collection processing storage and transfusion procedures are not affected by the proposed container The proposed container does not require any change or modification to the currently used blood bank operations The new container does not require any equipment extra space or special operatorsandapos trainings The new container that is equipped with bacteria elimination characteristics is set to safely and reliably extend platelet storage time up to days The platelets are maintained in a passive and composed environment during storage inside the container The platelets can easily flow out of the container during transfusion while the dead bacteria are trapped inside the container The use of the proposed container will solve major problem in transfusion medicine and it does not impose any extra cost or any financial burdens on the blood banks