SBIR-STTR Award

The purpose of the investigation is to perfect a novel optical device that measures the oxyhemoglobin saturation (%HbO,), total hemoglobin concentration (THb), and oxygen content of a blood sample in a glass capillary tube of the type commonly used for microhematocrit determinations. We have already built a prototype hemoglobinometer-oximeter that measures the quantities of interest by determining the sample's reflectance at two wavelengths, but the device's accuracy is insufficient in the low Thb and low % HbO, ranges. The device's advantages over other hemoglobinometers are that no chemical reaction is required (hence neither accurate dilutions nor toxic reagents are necessary), and that the device reads Thb ahnost instantaneously. In addition, the non-destructive measurement preserves the sample for further analysis; the device can be operated by unskilled personnel; the device can be made portable and thus can be operated in the field or at accident sites; the same sample-filled capillary tube can be centrifuged if a measure of hematocrit is also desired; the sample size is small (an important advantage in neonatal use); and the capillary tube is a widely available, inexpensive cuvette. If the investigation is successful, the envisaged portable oximeter-hemoglobinometer could compete successfully for an enormous market-hospitals and doctor's offices worldwide.Awardee's statement of the potential commercial applications of the research:Medical market experts estimate that an inexpensive, portable hemoglobinometer could be used in the U. S. at 26,000 different in-hospital sites, such as renal dialysis units or cardiac cath labs, and at 120,000 off-site locations, such as doctors' offices, rural locations, ambulatory care centers, blood donation sites, etc.. In 1991, one particular foreign manufacturer earned $5,400,000 in the U. S. on sales of a semi-portable hemoglobinometer and $30,800,000 worldwide from disposable cuvettes.National Heart, Lung and Blood Institute (NHLBI)

The applicants have developed proprietary techniques (patent pending) to make accurate spectrophotometric measurements directly in whole blood in spite of its well-known fight-scattering properties. Therefore, the goal of this project is to exploit this promising new technology by developing a portable, hand-held, hemoglobinometer-a spectrophotometric instrument capable of measuring the total hemoglobm concentration in a sample of unaltered, whole blood. An enormous demand exists for inexpensive hemoglobinometers, but those presently available suffer from many shortcomings. Some can be used only by skilled operators because they require accurate dilutions of the blood sample, often with toxic reagents. Second, they are usually slow because the processes of hemolysis and chemical conversion of hemoglobin into cyanmethemoglobln require time. Third, they alter the cellular and chemical composition of the sample rendering it unfit for further hematological analyses. By exploiting this new technology, the proposed instrument would avoid all of these problems by making its measurements directly in whole blood. Thus, the proposed hemoglobinometer would be so simple, fast, direct, nondestructive, and inexpensive that it would easily compete with the existing state of the art. During Phase 1, the applicants developed a prototype and demonstrated conclusively that the new technology yields accurate measurements of the hemoglobin concentration. Furthermore, this new technology yields even when the optical properties of whole blood were deliberately changed over wide ranges. The chief aims of Phase II are to miniaturize the prototype to a hand-held size, test it extensively, and develop calibration procedures.Awardee's statement of the potential commercial applications of the research: Medical market experts estimate that an inexpensive, portable hemoglobinometer could be used in the U. S. at 26,000 different in-hospital sites, for example, renal dialysis units, and cardiac cath labs. In addition, the hemoglobinometer could be used at 120,000 off-site locations such as doctors' offices, rural locations, ambulatory care centers, blood donation sites, etc. In 1991, one particular foreign manufacturer earned $5,400,000 in the U. S. on sales of a semi-portable hemoglobinometer and $30,800,000 worldwide from disposable curettes.National Heart, Lung, and Blood Institute (NHLBI)