Intranasal Tear Neurostimulator - Benefits, Dosage, and Mode of Action

Overview

An intranasal tear neurostimulator is commonly used for dry eye symptoms. Intranasal tear neurostimulators lead to neurostimulation, which enhances the production of tears and serves as a new treatment modality for dry eye syndrome. Stimulation of the lacrimal and anterior ethmoid nerves effectively increases the volume of thyroid hormone production.

The Intranasal tear neurostimulator is a noninvasive device that effectively increases the volume of tears and may improve tear composition, including mucin and lipid concentrations in the tear fluid. The intranasal tear neurostimulator device got the FDA (Food and Drug Administration) approval for commercial use in April 2017.

Many studies and research projects have demonstrated tear production and device safety. It is a small device that fits in the nasal cavity and delivers small electrical currents to the sensory neurons, stimulating tear production.

Indications

An intranasal tear neurostimulator is indicated to increase the production of tears by the tear glands during neurostimulation released by the device to improve the symptoms of dry eye in patients suffering from dry eye disease.

Usage

The device temporarily increases tear production and improves dry eye symptoms. However, it only suits some patients, who may respond differently to this device. Dry eye disease is a chronic disease that affects millions of people worldwide. Intra nasal neurostimulator is an evolving treatment modality for tear production through neurostimulation resulting in nasolacrimal reflex.

Benefits of Using an Intranasal Tear Neurostimulator

• An intranasal tear neurostimulator is a small device the patient can use.

• It is a small device that is easy to carry.

• The device produces a small microcurrent to stimulate the tear gland and does not cause any significant problems.

• It can be used multiple times.

For Patients

What Is Dry Eye Disease?

Dry eye disease is an eye syndrome in which the eye cannot make enough tears. Tears are essential for keeping eyes moist and protected. Tears have three layers, the outer layer is oily, the middle layer is watery, and the inner layer is a mucus layer. When the tear gland is inflamed or infected, it loses the ability to produce tears, resulting in eye syndrome. Dry eye disease is reported all over the world. It causes very uncomfortable feelings, and in some severe cases, it can lead to vision loss.

What Are the Signs and Symptoms of Dry Eye Disease?

Dry eye disease is a widespread problem.

Following are the signs and symptoms associated with dry eye disease.

• A scratchy feeling, like there's something in the eyes.

• Stinging or burning sensation in the eyes.

• Red eyes.

• Sensitivity to light.

• Blurry vision.

• Pain.

• Tiredness.

• Headache.

What Are the Causes of Dry Eye Disease?

The following are the causes that affect tear production in the eyes.

• Hormone replacement therapy.

• Exposure to the wind or dry air, such as constant exposure to a heater during the winter.

• Allergies.

• LASIK eye surgery.

• Medications include antihistamines, nasal decongestants, birth control pills, and antidepressants.

• Older age.

• Long-term use of contact lenses.

• Prolonged screen time.

How Does an Intranasal Tear Neurostimulator Work?

The intranasal tear neurotransmitter works through a process called neurostimulation. The device is small and has two strings inserted through the nasal cavity. When activated, it produces a painless microcurrent, which stimulates the neuroreceptors in the nasal cavity and sends the signal to the brain, producing tears.

Who Can Use an Intranasal Tear Neurostimulator?

An intranasal tear neurostimulator is indicated for patients with dry eye syndrome.

The following are the facts.

• The patient should be 22 years old.

• Have dry eyes from inadequate tear production.

• The patient should be able to use the intranasal tear neurostimulator.

• Intranasal tear neurostimulators should be avoided in patients with a cardiac pacemaker, defibrillator, or other metallic or electronic devices in the body.

• It should be avoided in patients with known hypersensitivity to the hydrogel material.

• People with chronic or recurrent nosebleeds, bleeding disorders, or other blood-related problems should not opt for an intranasal tear neurostimulator.

What Are the Complications Associated With the Use of an Intranasal Tear Neurostimulator?

Intranasal tear neurostimulators can lead to certain complications.

• Nasal pain, discomfort, or burning sensation.

• Itchy nose.

• Short-term electrical discomfort.

• Nosebleeds.

• Blood in the nostrils.

• Nasal congestion.

• Excessive sneezing.

• Numbness of the nose.

• Infection or abrasion inside the nasal membrane.

• Sore formation or ulceration.

• Irritation inside the nose.

• Lightheadedness.

• Headaches.

• Sinus pain.

• Sore eyes.

• Facial pain.

• Pain around the eye.

• Increased saliva production.

• The sensation of teeth vibrating.

• Excessive runny nose.

• Temporary increase in symptoms associated with nasal allergies.

• Allergic reaction to the material in contact.

• Potential permanent scarring of the inside of the nose with prolonged use.

Warnings of Intranasal Tear Neurostimulators:

Intranasal tear neurostimulators come with warning signs and contraindications to avoid potential safety hazards.

• Always follow the instructions properly given by the doctor before every.

• Do not use the device if electronic monitoring equipment is being used. For example, heart monitors or electrocardiograms (ECG).

• Do not use the intranasal tear neurostimulator device while bathing or showering.

• Do not use the device while driving or operating machinery.

• Do not use it when a person has a runny nose, sneezing, or watery eyes.

• Do not apply the device to the neck, chest, or areas other than the nose.

• Do not use the device if the nose is irritated. It can injure the nasal mucosa.

• Do not use the device within three feet of shortwave or microwave therapy equipment. It may stimulate the device.

• Avoid using the device in the presence of flammable materials.

What Are the Contraindications Related to Intranasal Tear Neurostimulators?

• Pregnancy.

• Patients under 22 years of age.

• Nose or sinus surgery, including a history of nasal trauma.

• Severe nasal airway obstruction.

• For a person suffering from disabling arthritis, neuropathy, severe dexterity impairment, or limited motor coordination, it would be hard to use the device for them.

• Chronic seasonal allergies.

• Rhinitis or sinusitis requires treatment such as antihistamines, decongestants, and oral or aerosol steroids.

• Untreated nasal infection

The Following Are the Precautions That Should Be Considered While Using the Intranasal Tear Neurostimulator

• It is recommended to consult a physician about the device's precautions before using it.

• If the patient feels pain, discomfort, or numbness in the nose with higher stimulation levels or a longer stimulation duration, reduce the level or avoid using the device for prolonged periods.

• It is important to discard the disposable tip every 48 hours and replace it with a new one for proper operation and good hygiene.

• Remove any studs, nose rings, or other piercings from the nose before using the device.

• Do not use prescription eye medications (eye drops, gels, or ointments) or nasal sprays within 30 minutes before or after using the device.

• Consult the doctor before use if a patient has suspected heart disease.

• Keep it out of children's reach.

• Always clean and sanitize the device before and after every use.

• If the patient experiences any fault in the device, they should consult or return it to the provider.

Bluetooth Connectivity

The intranasal tear neurostimulator device comes with Bluetooth connectivity technology. This technology comes with efficiency, which helps connect the device to a smartphone and records all the data and usage of the device. This helps in feeding the details and also sets a reminder for using the device and disposing of the tip that comes along with it.

Disposal and Replacement

The intranasal tear neurostimulator comes with a base unit, charger, and AC adapter that should be returned to the local distributor for recycling and disposal by any applicable local, state, and national regulations for disposal of electronic equipment or otherwise returned to the provider or physician. The tips may be discarded with the trash.

What Questions Should Patients Ask the Doctors Before They Use the Device?

Using an electronic device can be tricky for some patients, so it is important to clear up all the doubts and facts about the intranasal tear neurostimulator device.

The following are the questions that healthcare professionals should ask before administering the device.

1. What are the benefits of using the intranasal tear neurostimulator device?

2. Are there any other options than an intranasal tear neurostimulator device?

3. How often should the patient use the intranasal tear neurostimulator device?

4. Is this a temporary treatment?

For Doctors

Indication -

Intranasal tear neurostimulators are mainly indicated for patients suffering from dry eye syndrome. In addition, it can be indicated for diseases with dry eye symptoms like - conjunctivitis, Sjogren syndrome, eye malfunction, anterior blepharitis, and others.

Dosage -

The Intranasal tear neurostimulator is used up to a limit of 30 minutes in a single day.

It is advised to use it only for three minutes; more than that is not recommended. The patient should wait at least one hour before every use. Using the device twice daily for three minutes is recommended.

What Is the Mechanism of an Intranasal Tear Neurostimulator?

The intranasal tear neurostimulator works on the neurostimulation process, a novel technique that uses electrical currents to stimulate the nervous system for tear production.

An intranasal tear neurostimulator is an easy and simple device that fits in the nostrils and releases tiny electrical currents to stimulate the receptors, which pass the signal to the brain to stimulate the tear gland to produce tears.

What Is Nasolacrimal Reflex?

The Nasolacrimal reflex is caused by neurostimulation, which results in tear production. In recent years, neurostimulation causing the nasolacrimal reflex has been evaluated as a novel treatment for dry eye disease. Nasolacrimal is a neural reflex arc that begins with chemical, mechanical, or electrical stimulation of nerves present in the mucosa of the nose and ends with bilateral lacrimation.

The nasolacrimal reflex has an afferent branch that starts at the nose's anterior ethmoidal nerve of the mucosa. It travels towards the midbrain through the nasociliary branch of the ophthalmic division of the trigeminal nerve. The efferent pathway of the nasolacrimal reflex arc emerges from the pons and ultimately synapses on the lacrimal glands.

These nerve endings regulate the meibomian glands and conjunctival goblet cells, stating that the three major tear components—mucin, aqueous, and lipid; can all be directed by neurostimulation. Because the afferent portion of the nasolacrimal neural reflex arc is external to the lacrimal functional unit, it bypasses dysfunctional intermediary elements (e.g., the ocular surface) implicated in the inflammatory cascade of dry eye disease.

Targeting the nasolacrimal reflex allows restoring functionality to the lacrimal function unit through a top-down approach since the direct endpoint of the nasolacrimal neural reflex arc is the stimulation of tear glands such as the lacrimal and meibomian glands for the production of tears.

How Does an Intranasal Tear Neurostimulator Help in the Production of Tears?

The intranasal tear neurostimulator device consists of four components.

• A disposable tip is inserted into the nasal cavity and provides the contact surface of the nasal membrane to stimulate the target tissue in the nose.

• A reusable base unit produces the neurostimulation and enables the patient to control the neurostimulation.

• A reusable cover to protect the disposable tip.

• A charger to recharge the sealed battery inside the base unit.

• The disposable tip is connected to the base unit for stimulation. The tip contains a hydrogel material similar to that used in contact lenses. The tip provides the contact for conducting the stimulation current, produced by the base unit, to the target site on the inside of the nose.

• The tip should be removed and replaced every 48 hours.

• The reusable cover can be used to protect the tip between uses.

• Once the tip is removed, the base unit can be placed on the charger to recharge the battery in the base unit. Charge the base unit every 48 hours or when changing the tip.

What Are the Intensities of the Device?

The device has five stimulation intensity levels. The base unit vibrates briefly when a button is pressed to indicate an increase or decrease in stimulation level. A blue LED light will be lit to indicate the selected stimulation level. Setting the intensity level according to the patient's condition is important.