Diaraise

What it does

Diaraise improves the effectiveness of dialysis for patients who get inadequate dialysis (upto 50 percent). For the rest of the patients, it enables safe reduction of the duration of dialysis, thus, saving time and resources of the dialysis centres.

Your inspiration

After nine months of research in hospitals, 220 need statements, several related to kidney disease, were identified. I was deeply moved to see the patients face debilitating effects of the condition. Guided by experts and considering factors like criticality, potential social impact, and scope of innovation, a need statement of ‘increasing the rate of removal of toxins from blood’ was chosen. Flash: Before starting dialysis, the technicians repeatedly tap the dialyzer (filter) to remove air bubbles during the priming cycle. It triggered ideas related to the use of vibration and ultrasound to dislodge the particles clogging the membrane.

How it works

Diaraise is an accessory that is externally attached to the dialyzer during dialysis. It transmits ultrasonic waves into the dialyzer to create a stirring effect in order to dislodge the particles clogging the membranes of the dialyzer. The mild turbulence thus created, promotes diffusion and increases the rate of removal of toxins from the blood. The custom-engineered acoustic system, comprising the driving electronics, piezoelectric crystals, metallic base, and coupling medium, ensures efficient transmission of ultrasonic waves into the dialyzer. The frequencies, intensities, and durations of ultrasonic exposure suitable for the application have been arrived at through multiple experiments with several prototypes. In vitro tests with blood have proven that the solution is safe for blood and membranes and that it improves the rate of removal of toxins. The industrial design accommodates the technical requirements as well as the use cases of a dialysis centre.

Design process

A detailed study of kidney function, dialysis, and membrane processes was carried out to understand the problem well. The ideation process involved looking at similar applications like fuel filtration and straining in the kitchen. The generated ideas were filtered based on factors of safety and feasibility. Ultrasound was preferred as it was proven successful for some other membrane systems and its use in clinical applications was well established. The first two prototypes were found to be damaging the membranes of the dialyzer. The third prototype based on a different set of parameters was found to be safe and effective for the application. Guided by it and a few failed prototypes, more effective prototypes were built which could generate and transmit ultrasonic waves into the dialyzer. Their design involved considering the acoustic properties of various materials and upgrading the electronics driving the transducers. Using a hydrophone, a rheoscopic fluid, and a microscope, the best working prototype was chosen to be taken forward for the industrial design phase. More prototypes were fabricated considering usability, safety, and manufacturability. The nineteenth prototype is being built based on the stakeholders’ feedback and will be used for conducting clinical investigations.

How it is different

No device in the market reduces the clogging of the membranes to increase the efficiency of dialysis. The design of the ultrasonic transducers, their arrangement around the dialyzer, and the nature of the electronic signals driving them are novel and have been granted an Indian patent. Solutions like high-flux dialysis and hemodiafiltration also increase the amount of toxins removed from blood but require the blood flow rate from the patient to be higher than normal which may lead to medical complications in some patients. Also, high cost prevents these modalities from becoming viable and widely used. Diaraise makes conventional dialysis more efficient without requiring increased blood flow rates. It can pay for itself in a year due to the costs saved by reducing the duration of dialysis. It can save up to 4 million litres of water per day in the US and can enable more patients to be dialyzed in a day in resource-constrained countries like India.

Future plans

The design will accommodate the requirements of several standards for medical devices which Diaraise needs to comply with. Data is being collected through controlled testing in the clinical setting. The data and the improved design will be used to get necessary licenses and approvals for its regular clinical use. The prolonged use of Diaraise in the clinical setting will generate more insights that can be used for its refinement. Diaraise can be used for every dialysis session, enabling adequate dialysis for all the patients. For half of them, the duration of dialysis can be safely reduced by up to 25%, making dialysis more sustainable.

Awards

The project began in Feb 2018 as a part of a ‘Social Innovation Immersion Program’ funded by BIRAC, Govt. of India. In July 2019, the project got funded by the Govt. of Karnataka state. In July 2020, the Biotechnology Ignition Grant (BIG) was awarded to the project by BIRAC along with the incubation at CCAMP (NCBS).