MECHANICAL VENTILATOR  (Other Technologies)

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Introduction:

The Health care facilities of the Nation were not prepared to deal with the tremendous influx of critical patients owing to the COVID 19 outbreak. CSIR-CMERI as a testimony to demand-based translation of R&D developed the Mechanical Ventilators to provide immediate and indigenous solutions for the pressing need.

The first version of the CSIR-CMERI developed Mechanical Ventilator (Device I) was aimed at makeshift hospitals and isolation wards. It uses a Cylindrical Bellow that controls the tidal volume through mechanical compression much better than a Bag Valve Mask (BVM) or AMBU Bag. It is ideal for makeshift hospitals with large number of beds. The mechanism is sufficient to handle Peak Inspiratory Air Way Pressure (PIP) up to 70 cm of H2O.

The second variant of the CSIR-CMERI developed Mechanical Ventilator (Device II) accepts oxygen through pipelines available in hospitals or can be coupled with medical air compressor/oxygen cylinders to provide increased functionality and low-cost ventilator solutions for the ICUs.

It was later realized from various journals of international repute that high flow oxygen therapy was providing much better results and therefore CSIR-CMERI tuned its R&D direction towards developing an affordable Mechanical Ventilator with an integrated Oxygen Enrichment Unit (Device III). The addition of the Unit into the CSIR-CMERI developed Ventilator has helped in multiplying its portability and therefore facilitating its usage in diverse and a variety of critical medical scenarios. This is especially useful for patients in the initial stages of the disease and with the help of competent medical support staff can be an effective medical tool.

Another critically decisive parameter that needs to be assessed in real-time to provide effective medical therapy to critically ill patients is the measurement of Oxygen saturation levels of an individual. The third version i.e. the Advanced Multi-functional Ventilator with integrated Oxygen Enrichment Unit and SPO2 measuring sensors provides real-time Oxygen saturation levels in blood and therefore provides a comprehensive picture of medical intervention needs of an individual. This variant of the Mechanical Ventilators provides a veritable alternative as a non-invasive oxygen therapy option for critically ill individuals.

However, integrating three different functionalities into a single unit comparable in size to a typical ventilator is technically very challenging. The high nasal flow system demands at least 40 LPM enriched oxygen flow whereas the oxygen enrichment unit requires at least 8-10 times of air input as compared to its output. Again, the compressed air generating unit of the system cannot be too heavy and noisy, thereby defeating the very purpose of using it in hospitals. Therefore, the specifications and the design of the system are optimized to provide a proper balance among the requirement, size (including ergonomics) and cost.

These CSIR-CMERI developed Mechanical Ventilators are an affordable alternative solution for the huge import costs associated with importing Mechanical Ventilators at huge costs. The indigenous development of these ventilators will also help a wide-spectrum of small-scale industries as the boosted demand for affordable Ventilators will play a significant role in job-creation and dramatically changing the medical equipment manufacturing scenario across the nation.

The detailed specifications of various Mechanical Ventilators are described below in reverse chronological order.

Device-III: Mechanical Ventilator with Integrated Oxygen Enrichment Unit

During pandemics, hospitals face severe shortages in ICU beds with oxygen, ventilators and other associated devices on demand for a large patient population that needs care. These are to be applied to patients who are critically ill, based on proper assessment. In absence of a proper screening mechanism, hospitals generally allot these ICU beds to patients who have a falling SpO₂ (below 88%) on a first come first serve basis to avoid any controversy. This results in a situation where a patient who really needs these resources is denied admission owing to unavailability of ICU beds.

Once newer information and results about the COVID-19 patients started revealing that most of the patient may be cured through Oxygen Therapy alone without needing ventilation, CSIR-CMERI tuned its research towards developing an Advanced Multifunctional Ventilator with integrated Oxygen Enrichment Unit, which is capable of providing Normal as well as Nasal High Flow (NHF) Oxygen Therapies. This unit is capable of generating its own oxygen rather than using oxygen from hospital and has an inbuilt SPO₂ measuring sensor, which displays in real-time the patients’ Oxygen saturation level in blood.

The current innovation has been tuned to perform all the tasks as highlighted in the below flow-chart. If even after these procedures, the SpO₂ levels do not rise above 90%, then that patient may be shifted to the ICU.

Specifications:

• Therapy Types: Invasive Ventilation, Non-invasive Ventilation, Standard and Nasal High Flow (NHF) O₂ Therapies

• Standard O₂ Therapy: Continuous Flow of 2- 5 L/min @ 21-70% FiO₂

• Nasal High Flow (NHF) O₂ Therapy*: Continuous Flow of 2- 40 L/min @ 21-80% FiO₂ (*Max O₂ concentration of 80 % @ 5 L/min and 30 % @ 40 L/min)

• O₂ Concentration (FiO₂) ^#: 21 – 80%; (^# Inbuilt oxygen enrichment unit, measured at 5 LPM)

• Mechanical Ventilator

  • Ventilation Modes: VC-AC, PC-AC, VC-SIMV, PC-SIMV

  • PIP: 20-70 cm of H₂O (adjustable in steps of 1)

  • PEEP: 0-20 cm of H₂O (adjustable in steps of 1)

  • Inspiratory Flow: 2- 70 L/min

  • Trigger: Flow Trigger (1-10L/min), Pressure Trigger (2-5 cm of H₂O)

  • Inspiratory: Expiratory ratio (I:E): 1:0.3 - 1:4 (adjustable in any ratio)

  • Respiratory Rate (BPM): 10 – 40 breaths per minute in increments of 2

  • Tidal Volume: 150 ml – 800 ml in steps of 50

  • O₂ Concentration (FiO₂) : 21 – 80% (inbuilt oxygen enrichment unit) , up to 100% with external O₂ supply

  • SpO₂: Patient’s Oxygen Saturation displayed in real time

  • Alarms: Standard & customizable alarms

  • Mechanical fail-safe valves (in case of electrical/ electronic failure): Opens at 80 cm of H₂O; Opens at 2 cm of H₂O (anti-asphyxia valve)

The idea behind this development is to reduce the cost of the technology drastically and use as much indigenous material as possible. This result in a product, multiple units of which can be purchased by a hospital at the cost of a single, more advanced device.

Majority of hospitals in rural areas cannot afford to maintain any gas pipeline to supply oxygen and 'medical air'. Oxygen cylinders, as an alternative, are often unavailable. The current innovation has a capability to enrich oxygen levels in atmospheric air, and does not require any gas pipeline or oxygen cylinder. This is an attractive feature, which makes this innovation very useful in hospitals, medical colleges and nursing homes, where there is no gas pipeline due to high initial investments. The size and weight of this innovation is such that multiple units can easily be transported to remote areas, providing healthcare to people who may not have any option to access it without travelling to faraway cities.

Device-II: Mechanical Ventilator with both Pressure and Volume Support

This ventilator was developed keeping in mind the requirements of hospitals with pipelines for medical air and oxygen. In absence of pipelines, the unit can be attached to any medical grade compressor and oxygen cylinder. This device is suitable for both passive as well as active patients and have support for both Volume and Pressure.

Specifications:

• Modes available: VC-AC, PC-AC, VC-SIMV, PC-SIMV

• PIP: 20-70 cm of H₂O (adjustable in steps of 1)

• PEEP: 0-20 cm of H₂O (adjustable in steps of 1)

• Inspiratory: Expiratory ratio (I:E): 1:0.3 - 1:4 (adjustable in any ratio)

• Respiratory Rate (BPM): 10 – 40 breaths per minute in increments of 2

• Tidal Volume: 150 ml – 800 ml in steps of 50

• FiO₂: 21 – 100%;

• SpO₂: Patient’s Oxygen Saturation displayed in real time

• Alarms: Standard alarms

• Mechanical fail-safe valves (in case of electrical/ electronic failure):

  • ​ Opens at 80 cm of H₂O;

  • Opens at 2 cm of H₂O (anti-asphyxia valve)

Device-I: Mechanical Ventilator with Motorized Bellow:

This Mechanical Ventilator was developed after innumerable feedbacks from registered Medical Professionals as greater understanding of proper functioning and usage of ventilator was essential. As a testimony, one hospital (M/s Vivekananda Hospital Pvt. Ltd., Durgapur) has certified that the system is suitable for emergency department, during transport, field management and in Critical Care Units. Further, a team of medical professionals from another hospital (M/s Health World Hospitals, Durgapur) has highly appreciated the indigenous mechanical ventilator of CSIR-CMERI and stated its suitability for Emergency departments, Critical Care Units and during transport/ field management outside the hospital settings. The current pandemic has forced the authorities to develop makeshift Quarantine / Isolation wards for the COVID-19 affected patients. In such isolation wards / small clinics / nursing homes, the developed Mechanical Ventilators are very much useful and provides a cost-effective solution. These Mechanical Ventilators, in combination with relevant medications and timely intervention of Nursing / Medical Support Staff, can be the vital deciding factor between Life & Death of a critical patient. Micro to small enterprise may take interest in the production and maintenance of mechanical ventilator. There is a possibility of easy funding for this type of essential and lifesaving sub-system. The broad specifications of the Basic Ventilator developed makeshift hospitals and emergency wards are as below:

Specifications:

• A micro-controller along with pressure and flow sensors in closed loop:

  • (a)   Continuously monitors and displays pressure, volume and flow with time in the monitor

  • (b) Parameters can be set on the fly through the GUI like Tidal Volume, BPM, I:E Ratio, PEEP and PIP

  • (c) Alarms for different set limits

• Mechanical fail-safe valve: opens at 80 cm H₂O if there is electrical/electronic failure

• PIP: 40-70 cm H₂O adjustable in steps of 5 cm H₂O

• PEEP: 5-20 cm H₂O adjustable in steps of 5 cm H₂O

• Inspiratory: Expiratory ratio (I:E): 1:1 - 1:3 (adjustable)

• Respiratory Rate (BPM): 10 – 30 breaths per minute in increments of 2

• Tidal Volume: 350 ml – 650 ml in steps of 50 ml

• FiO₂: Two options – 50-60% & 80-90% through

• Modes available (“Volume Assist/Control”):

  • Volume Control (VC) – Continuous Mandatory Ventilation (CMV), for PASSIVE patients

  • Volume Control (VC) – Intermittent Mandatory Ventilation (IMV), for PARTIALLY ACTIVE patients

Feedback from Hospital 1: Download

Feedback from Hospital 2: Download

CMERI research paper on ventilator: Click Here

Watch live discussion on Indigenous ventilator: Click Here

News Article: Click Here