GOVERNMENT TIRUVANNAMALAI MEDICAL COLLEGE

AND HOSPITAL

MEDMUN HEALTHTECH HACKATHON PROJECT - 2020

NON INVASIVE VAGAL NERVE STIMULATING DEVICE

Kishore.R ; Prefinal Year MBBS ; Government tiruvannamalai medical college

Prathik.S ; Prefinal Year MBBS ; Government tiruvannamalai medical college

Vignesh.R ; Prefinal Year MBBS ; Government tiruvannamalai medical college

Budget:

Signature of the Project Students Signature of the Project Guide(s)

Signature of the HOD

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Non Invasive Vagal

Stimulator for
Asthmatics
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TABLE OF CONTENTS
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1. Project Title

2. Broad Subject

3. Project Duration

4. Budget

5. Project Summary

6. Keywords

7. Objectives

8. Introduction

9. Definition of the Problems

10. Review of status of Research and Development in the subject

10.1 National Status

10.2 International Status

11. Novelty Importance of the proposed project in the context of current status

12. Patent details

13. Work plan and detailed technical information

13.1 Methodology

14. Time schedule of activities giving milestones

14.1 Time Schedule of Activities through BAR Diagram

15. Deliverables

16. Target beneficiaries of the proposed work

17. Suggested plan of action for utilization of research outcome expected from the
project

17.1 As journal publication

17.2 Patent filing
17.3 Project preparation for submission to external funding

18. References
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19. List of facilities and Equipments available with Department for the project

20. Budget Estimates

21. Budget Justification

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1. Project Title: Non invasive Vagus stimulator for asthmatics with

/ without COVID.

2. Broad Subject:
It is a non-invasive device that is being developed to measure the jugular
venous pressure of a patient. Our device comes in handy for the patient to measure
his/her own JVP. It consists of ECG electrodes to sense ECG signals, microphone to
pickup signals, and amplifier to amplify and separate the JVP signal. It is easy to
maintain the data of a particular person because digital output is obtained. It is enough
that the patient has the only job of keeping our device in the left or right side of the
neck to measure it. Further the device is very scalable to integrate into any healthcare
system present in the world, making the diagnosis process very easy. The main
concept of our project is to eliminate the traditional manual method and to avoid the
requirement of a trained technician. The future in healthcare systems is personalized
and real time devices which can be self-monitored by the patient himself. Our idea is
to give the device to the people, the healthcare device industry is a 13.3 billion dollar
industry and we plan to occupy a small part of it, in the near future.

3. Project Duration: 10 Months

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4. Budget: 21,000(twenty one thousand)

5. Project Summary ( What's the hack? ) :

This project is our first ever project which is of actual use to the healthcare
society and being able to do a project itself excites us, we plan to take
biomedical field in India to a level where the current ratio of 0.65 doctors per
1000 people can be compensated by using remote monitoring device like
this[3]. Our ultimate goal is to revolutionize healthcare reducing the need for
doctors for most of the diseases. Furthermore this would be our way to save a
thousand lives along with the help of doctors.

These vistas begin with this modest project proposal to build a device to
stimulate vagus nerve in asthmatics using non-invasive methods which provides
real-time monitoring of the patient providing vital information about the
functioning of the lungs. We have thoroughly researched about the various
devices and patents related to our novel device, even though the idea has been
prevalent, there have been many patents submitted and prototype ideas
proposed but no one has come up with a full-fledged working device which is
precisely what we propose to do with the help of this internal fund.

In this design, the purpose for stimulation of the vagus nerve is solely for use in
critical conditions like status asthmaticus. People stricken with COVID-19
exhibit a wide range of symptoms. Some are barely affected while others suffer
dire consequences. People with asthma are in particular danger, as SARS-CoV-2
is a respiratory virus that can make breathing even more difficult. This non-
invasive vagus nerve stimulator (nVNS) to help adult asthmatics with COVID-
19 (or those suspected of being infected) overcome difficulties breathing when
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drugs are not appropriate or are insufficient. Our hack illustrates the potential
benefit of utilizing complementary treatment as part of the management of a
patient presenting with acute asthma. Utilization of this form of vagal
stimulation could reduce dose of medications and its side effect.

6. Keywords:
a) Asthma
b) Visual Analogue Scale
c) Vagus nerve stimulation
d) Acute asthma
e) Cromolyn

7. Objectives:

1. To make non invasive method of stimulating the vagus nerve for the use of
asthmatics in critical conditions like acute asthma attack or status
epilepticus.

2. To develop a user friendly system to inexperienced people.

3. To test and analysis the measurement of JVP.

4. Hands-free device for measurement display.

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8. Introduction:

9. Definition of the Problems:

90 per cent of childhood asthma and 50 per cent of adult asthma is caused due
to environmental allergens.

With an estimated 1.5-2 crore asthma patients, at least one in every 10 asthma
patient globally lives in India. Globally, the economic costs associated with
asthma exceed those of TB and HIV/AIDS combined. Considered the most
common chronic disease among children, Asthma is prevalent in all countries,
whether they are developed or underdeveloped. In fact, over 80 per cent of
asthma deaths, according to the World Health Organization (WHO), occur in
low and lower-middle-income countries.
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According to (GINA2019) the role of complementary and alternative medicine

in adult asthma treatment are limited because these approaches have been
insufficiently researched and their effect are largely unproven [2].

The parasympathetic nervous system are the primary regulators of pulmonary

smooth muscle tone. Postganglionic parasympathetic nerves mediate both
cholinergic contractions and inhibitory non-adrenergic non-cholinergic
(iNANC) relaxations. It is the close balance between these two that ultimately
determines airway caliber. These relaxation and contraction responses are
through anatomical and physiological distinct vagus nerve pathways [3].

10. Review of status of Research and Development in the

subject

10.1. National Status:

No special device has been developed to treat critically ill asthma patients
with a vagus stimulator so far, but there are traditional methods which are time
consuming and inaccurate are being employed, the direct invasion of the
parasympathetic nervous system has been omitted and developments in this
forefront are not being conducted seriously. This device can sense, and even
record the Severe shortness of breath, chest tightness or pain, and coughing
or wheezing and help the doctor understand the cause of the problem
thoroughly.

10.2. International Status:

An implantable vagus nerve stimulator is currently FDA-approved to treat
epilepsy and depression. But usage of this device in crirical management of
asthma is still under the radar and researches are being done in the United
Nations.
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11. Novelty Importance of the proposed project in the context of

current status:

Proposed on the pioneering concept of using vagal neuromodulation to acutely

treat patients with severe bronchoconstriction during an asthma attack, we can
also use this concept to expand beyond the acute emergency indications and
produce a prophylactic vagus nerve stimulation therapy option. Their initial
focus on asthma can also expand quickly into migraine and cluster headache
and new trials are continuing to investigate new uses for nVNS for gastric
motility, pain, and sleep disorders, as well as depression and anxiety. Currently
in India , the news of Sushanth Singh Rajput's demise has made a huge setback
to ponder over the mental health developments in our country and this device
could help tackle this issue too.

12. Patent details:

Methods and Apparatus for Non invasive stimulation of vagus
nerve
Patent Code: AU2019201050B2
Devices, systems and methods are disclosed for non-invasive capacitive electrical
stimulation and their use for vagus nerve stimulation on the neck of a patient. This
technology can be modified and used for treating bronchial constriction related to asthma,
anaphylaxis or chronic obstructive pulmonary disease. Our proposal comprises transmitting impulses
of energy non-invasively to selected nerve fibers that are responsible for smooth muscle dilation. The
transmitted energy impulses, comprising magnetic and/or electrical, mechanical and/or acoustic, and
optical and/or thermal energy, stimulate the selected nerve fibers.

US10207106B2 2019-02-19 Non-invasive magnetic or electrical nerve stimulation to treat

gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders

US9861811B2 2018-01-09 Electrical stimulator for treatment of back pain and methods of
use

US20170225005A1 2017-08-10 Cooling systems and methods for conductive coils

US10300270B2 2019-05-28 Device and method for the treatment of cardiac disorders

US20190209839A1 2019-07-11 Non-invasive vagus nerve stimulation devices and

methods to treat or avert atrial fibrillation

US20190358451A12019-11-28Mobile phone for stimulating the trigeminal nerve to treat

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disorders

US10350411B22019-07-16Devices and methods for treating medical disorders with

evoked potentials and vagus nerve stimulation

US20170189684A12017-07-06Monitoring and regulating physiological states and

functions via sensory neural inputs to the spinal cord

US10335593B22019-07-02Devices and methods for monitoring non-invasive vagus nerve

stimulation

US9630004B22017-04-25Method and apparatus for transdermal stimulation over the

palmar and plantar surfaces

US10286212B22019-05-14Nerve stimulation methods for averting imminent onset or

episode of a disease

US20160074671A12016-03-17Method of treating or alleviating a patient with

incontinence

US10384060B22019-08-20Electrical stimulation for treating neurological disorders

EP2691149B12019-02-27System for treating apnea using evoked swallow

US8430805B22013-04-30Method and apparatus for magnetic induction therapy

Laghi et al.1996Comparison of magnetic and electrical phrenic nerve stimulation in

assessment of diaphragmatic contractility

US20130274842A12013-10-17Method of routing electrical current to bodily tissues via

implanted passive conductors

EP2318093B12019-11-13Systems for automated muscle stimulation

US20130296964A12013-11-07Breathing disorder detection and therapy delivery device

and method

AU2019201050B22020-03-26Devices and methods for non-invasive capacitive electrical

stimulation and their use for vagus nerve stimulation on the neck of a patient

US8494625B22013-07-23Methods and apparatus for electrical stimulation of tissues using

signals that minimize the effects of tissue impedance

13. Work plan and detailed technical information

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14. Deliverables:

a) Standards and Specifications: For this device to be used in clinics and

hospitals, patient consent will be necessary before the device is used for
nerve stimulation .

b) Patient: The patient must feel comfortable during the procedure. It is

important to withhold patient dignity and ensure that there are no negative
side effects.

c) Patient-related concerns: The data should be protected under the patient-

doctor confidentiality agreement. The device must be comfortable and easily
operated.

15. Target beneficiaries of the proposed work

1. The device will be used daily at a clinic and must be able to withstand
normal wear and tear. The feedback must be easily understandable by the user
2. The device must be able to be safely placed on the body and cause no harm
to the patient.
3. The main aim is to eradicate the problems due to earlier techniques and for
the management of acute exacerbations in the person concerned.
4. There will be no need of a trained technician to alter the nerve response ; the
device is handy for anyone. The patient itself can use it to stimulate his vagus
nerve and stop the device.
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16. Suggested plan of action for utilization of research outcome

expected from the project

16.1. As journal publication:

We will be publishing in the Journal (National/International) after the successful
completion of our project.
16.2. Patent filing:
As of now we have planned to submit to the patenting authority of India after
successful completion of the project.

16.3. Project preparation for submission to external funding:

After the completion of the project, we hope to submit it to an external agency for
external funding.

17. References:
1. Centers for Disease Control and Prevention. National Surveillance for Asthma
– United States, 1980–2004. Morb Mortal Wkly Rep. 2007;6(SS08):1–14. 18–
54. [Google Scholar]
2. American Lung Association ESU. Trends in asthma morbidity and
mortality. 2010. http://www.lungusa.org/finding-cures/our-research/trend-reports/
asthma-trend-report.pdf.
3. Miner JR, Lewis LM, Mosnaim GS, Varon J, Theodoro D, Hoffman TJ.
Feasibility of percutaneous vagus nerve stimulation for the treatment of acute asthma
exacerbations. Acad Emerg Med. 2012;6(4):421–429. doi: 10.1111/j.1553-
2712.2012.01329.x. [PubMed] [CrossRef] [Google Scholar]
4. Diamond L, O'Donnell M. A nonadrenergic vagal inhibitory pathway to feline
airways. Science. 1980;6(4440):185–188. doi: 10.1126/science.7361114. [PubMed]
[CrossRef] [Google Scholar]
5. Blaber LC, Fryer AD, Maclagan J. Neuronal muscarinic receptors attenuate
vagally-induced contraction of feline bronchial smooth muscle. Br J
Pharmacol. 1985;6(3):723–728. doi: 10.1111/j.1476-5381.1985.tb08951.x. [PMC free
article] [PubMed] [CrossRef] [Google Scholar]
6. Hoffmann TJ, Mendez S, Staats P, Emala CW, Guo P. Inhibition of histamine-
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induced bronchoconstriction in guinea pig and swine by pulsed electrical vagus nerve
stimulation. Neuromodulation. 2009;6(4):261–269. doi: 10.1111/j.1525-
1403.2009.00234.x. [PubMed] [CrossRef] [Google Scholar]
18. List of facilities and Equipments available with Department
for the project

List of Labs available

   Bio Instrumentation Lab

     Medical Software Lab

     Project Incubator Lab

     Diagnostic and Therapeutic Lab

     Clinical Engineering Lab

     Tissue Engineering Lab

     Biomems& Nanotech Lab

     Medical Informatics Bioscience Lab

     Physiology Lab

The labs are equipped with high end equipments like EMOTIV
EEG, Fluorescence microscope, CO2 Incubator etc., design software like MIMICS
Innovation Suite, CREO and 3D printer for use .The medical software labs have
almost all the high level software’s for use and also the instrumentation lab fulfill our
requirements.
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19. Budget Estimates: Approximately Rs./-

20. Budget Justification: