iSAVE

Market Suggested Retail Price

$820.00

Distributors / Implementing Organizations

 Indventr (simelabs, ionic3DP, aruvii), Welfare services Ernakulam "Sahrudaya", Aimed Solutions

Manufacturing/Building Method

The product is mass produced and manufactured by AIMED Solutions, located in Netherlands, and in Chennai (India)

Intellectural Property Type

Open Source

User Provision Model

Direct purchase to the manufacturer, AIMED Solutions.

Distributions to Date Status

Unknown.

Design Specifications

The iSAVE uses a series of valves and flow regulators in parallel limbs to effectively maintain the desired tidal volume and positive end-expiratory pressure for each patient, customizing therapy for each patient. This device aims to provide a personalized respiratory care, since it multiplexes a ventilator to two patients and customize treatment to each patient’s respiratory needs. The iSAVE enables patient-specific volume and pressure control, have valves to mitigate cross-contamination between patients and accommodates changing patient mechanics. Additionally, it offer increased safety and reduced oversight burden by having a portable monitor, enabling monitoring outside of patient rooms in a centralized ICU space, reducing exposure risk to physicians and nurses, centralizing workflow and decreasing nursing burden. iSAVE show ease of use and assembly, since its features, alarms and management is similar to the existing respiratory monitors, making it familiar to users. It can be assembled in less than 10 minutes, even by a non-medical technician.

Technical Support

Provided by the manufacturer (AIMED Solutions)

Replacement Components

Consumables utilized with this device would be the standard filters and tubing required for ventilation of patients supplied by the hospital itself.

Lifecycle

Unknown

Manufacturer Specified Performance Parameters

The iSAVE can handle differences in patient ventilatory needs, however, some ventilator parameters (RR, FiO2, I:E, PEEP) will remain shared amongst patients. Thus, patients should be matched as closely as possible in terms of degree of illness and ventilatory needs to optimize functioning as per the following criteria, where possible:

• FiO2: patients requiring FiO2 > 60% should be grouped separately from patients requiring FiO2 < 60% given common FiO2 settings and a desired threshold to lower FiO2 < 60% to avoid potential O2 toxicity
• Compliance: patients with a C  30 cmH2O should be grouped separately from patients with C > 30 cc/cmH2O
• PEEP: should be within the range of 5-18 cmH2O and the difference between patients should be minimized to less than 5 cmH2O
• Driving pressure: should be within the range of 5-15 cmH2O and the difference between patients should be minimized to less than 6 cmH2O
• Difference in height: should be minimized to 3-6 inches to ensure relatively similar tidal volume needs

Vetted Performance Status

iSAVE has been validated using benchtop models as well as in vivo studies on large mammals, demonstrating its potential to deliver multiplexed and personalized ventilation through a system of valves and sensors, with embedded safety measures.  The results show that the system enables patient-specific titration of V_T, inspiratory pressure, and PEEP, significantly amplifying the capacity of a single ventilator. In a set of scenarios mimicking the clinical evolution of patients with acute respiratory distress syndrome (ARDS) and sudden events that could jeopardize the ventilation of other patients, the system is able to handle circuit dependencies and deliver the desired therapeutic parameters to each channel. These results indicate the potential for rapid translation into clinical use to address the current ventilator shortage as a result of the COVID-19 pandemic.

Safety

Unknown

Complementary Technical Systems

None

Academic Research and References

Compliance with regulations

Unknown

Other Information

None