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Multiple biosensor device for hemodialysis patients

Commercially viable analytical device, detecting glucose, urea, sodium and potassium concentrations in blood and biological fluids, suitable for monitoring patients with renal diseases undergoing hemodialysis treatment

The project is envisaged to create a device that measure concentrations of urea, sodium and potassium ions in blood or physiological fluids, suitable for monitoring patients with renal failure undergoing hemodialysis treatment. These parameters provide essential information about effectiveness of hemodialysis treatment, improving medical service quality. The device will be fully automatic, not requiring professional assistance, compact and mobile (bottom area is about the same as regular laptop computer), cheaper as compared to alternatives in respect to purchase price and cost of one measurement. There is a possibility to include glucose concentration in blood parameter establishment, however, it is a technological and practical challenge and such inclusion will be discussed. Most important parameter to monitor - urea concentration in blood before and after the hemodialysis treatment, as the main factor of renal failure is incapability to remove urea from blood. Main hygienic standards for hemodialysis management are related to urea reduction ratio in blood before and after the treatment. It is convenient to monitor urea removal by analysis of urea concentration changes in hemodialysis waste fluid (dialysate), and such equipment exists. They can estimate how many times the concentration of urea has dropped in blood after dialysis by employing spectroscopic monitoring of dialysate, and they calculate the widely adopted Kt/V parameter, however, this is relevant when initial urea concentration in blood is known. Currently, blood samples of hemodialysis patients are collected and analyzed in laboratories once a week or month, the analysis involves 30 - 40 of other parameters as well, and the answer is available after 2 - 4 hours. More frequent analysis is not cost - effective, and widely adopted standards state that such frequency is adequate. In reality, urea concentration in patients vary by days (Mondays - highest, Fridays - lowest) or even hours, so the Kt/V parameter itself is not entirely relevant. Another parameters are complementary, but important as well. Monitoring the glucose concentration in blood for patients is a benefit, because i) a fair amount of patient with renal failure also experience diabetes mellitus; ii) diabetes is a major cause of renal failure; iii) one of the treatment strategies for diabetes is hemodialysis. Real-time glucose fluctuations for such patients during hemodialysis is considerable and neglect could lead to serious health problems. Poorly functioning kidneys can't maintain homeostasis of sodium and potassium ions in blood as well, and special care is taken for the patients involving diet and hemodialysis procedure adjustments. Thus the device is designed to monitor key parameters for safe hemodialysis procedure and good outcome. It would have two main functions - manual blood sample analysis and on-line monitoring of dialysate for prediction of blood parameters by comparing initial blood sample with dialysate composition. On-line prediction is useful to assess the time needed for hemodialysis treatment. Some treatment procedures involve inclusion of glucose, sodium or potassium in dialysis fluid, interfering the on-line analysis, so the operator would have to choose which parameters to follow. The device consists of automatic sample, buffer and reference solutions managing fluid injection system, input and output devices (screen, buttons, thermal printer, etc.), without the need of professional operation personell. The breakthrough technology enabling the construction of such device is amperometric urea biosensor electrode, developed by researchers of Institute of Biochemistry of Vilnius university, which is stable (could be used for as long as 6 months), capable of measuring urea concentration by declared accuracy of 5 % when the automatic calibration is performed every 3 hours. The device is projected to be sold at a price of ~2 530 Eur, also requires electrodes and solutions sold for ~160 Eur/year, and the sample measurements could be performed regularly at ~10 min intervals for the whole service time without additional cost. In comparison, a single sample for biochemical analysis mentioned before costs ~3 Eur, while in our case the price for single measurement (when the device is on full workload for 8 h/day) should be ~0,001 Eur, excluding device purchase cost. The project would involve several steps: i) creation of initial prototype and fluid management model stand for professional testing and debugging; ii) refinement of urea biosensor electrode; iii) research of relationships of measured parameters in blood and dialysate; iv) construction of final, comercially viable device.
Acronym: 
HemoSensor
Project ID: 
8 835
Start date: 
01-05-2014
Project Duration: 
24months
Project costs: 
270 000.00€
Technological Area: 
Medical devices technology (instrumentation, medical imaging, radiology)
Market Area: 
Diagnostic test products and equipment

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