About 9.86 crore people (8%) in India suffer from sinusitis, according to the Government of India’s Union Ministry of Health and Family Welfare. Of these, for the chronic cases who do not benefit from medication, a team of researchers at InnAccel, Bangalore, has developed a device called SinuCare to provide long-term relief within a day.
Sinusitis is a condition in which the openings of the sinuses (the cavities in the bones in our forehead, cheeks, and the nose which form the respiratory tract from the nose into the throat) swell and clog the airflow inside them. The inflammation (swelling and redness) is caused due to infection, allergies, air pollution, or structural issues in the nose. Some of the common symptoms of sinusitis are thick nasal mucus, a plugged nose, pain in the face, fever, headaches, poor sense of smell, sore throat, and/or cough.
Why it matters
In most cases, sinusitis can be treated by medication. However, it is considered as a chronic case if the condition continues beyond three months. To chronic sinusitis patients who fail to benefit from medicines, doctors usually suggest functional endoscopic sinus surgery (FESS) to widen the sinus openings, clear any collected secretions, and to ventilate the sinuses and the nasal cavity. However, FESS is not only an expensive procedure, but is also quite invasive, as it requires surgical removal of many bony structures within the nasal cavity. It, therefore, carries a higher risk of complications and over-ventilation of the sinuses which can hamper its normal functioning.
As per a survey conducted by the InnAccel team, of the total number of sinusitis patients who visit an ENT doctor, on an average nearly 45 percent are counseled for FESS. However, most patients choose to try alternative forms of healing and avoid surgery till the extent it becomes essential. Two major reasons for this that emerged from the survey are: the cost (in India FESS cost ranges from Rs. 60,000 to Rs. 130,000) and the fear of complications or physical damage due to the operation under general anesthesia.
SinuCare is a minimally-invasive balloon sinuplasty device meant primarily to provide chronic sinusitis cases a cost-effective and safer alternative to FESS.
“With SinuCare we have tried to alleviate the concerns of chronic sinusitis patients. SinuCare is a simple metal device that uses a disposable double-balloon dilator, which is inserted into the blocked sinus openings through the nose. When the double-balloon dilator is inflated with saline in the blocked cavity, it expands and remodels the sinus openings, clearing the respiratory cavities by causing tiny bone fractures. Unlike FESS, balloon sinuplasty using SinuCare does not require any tissue removal, thus decreasing the risk of complications that arise from excessive removal of bony tissue and reducing the time for recovery. Moreover, an ENT doctor can operate SinuCare in his or her clinic, thereby reducing the cost of hospitalization for the patient,” explains Dr. Jagdish Chaturvedi, 33, who is a co-inventor of SinuCare.
Dr. Chaturvedi is an ENT specialist in Bangalore. In 2016, he won the MIT Technology Review’s TR35 Award for Young Innovators under 35 for one of his medical device innovations. At InnAccel, he develops new medical devices with cross-disciplinary teams and mentors young researchers and professionals in their entrepreneurial endeavors.
He is now conducting awareness sessions for ENT doctors on the use and benefits of SinuCare. “We have trained over a 100 ENT surgeons across the country and some of these doctors have started counseling and treating patients with SinuCare and the feedback from them and the patients has been very satisfying. I am also travelling to various cities to perform surgeries and train doctors on how to use SinuCare,” he adds.
The InnAccel team has filed a patent in India for SinuCare. They have also applied for the CE (European Union) quality certification for the device.
How it works
SinuCare comprises a navigation system through which the doctor manually inserts a soft polymer double-balloon dilator into the nose, to unclog the openings of blocked sinuses.
When the double-balloon dilator reaches the target, the doctor infuses the balloons with saline at 12 atmospheric pressure with the help of a pressure pump. As the balloons expand to their maximum diameter of six millimeters, they remodel the sinus opening and allow the mucus to drain out from the cavity, giving way to better ventilation. Finally, the dilator is removed and the device is pulled out of the patient’s nasal cavity.
The procedure is repeated for each blocked sinus. Following the complete procedure, the doctor keeps the patient under observation for an hour as a precautionary step to watch for any bleeding or dizziness. It takes about four to five hours for the entire procedure to complete, from the time the patient is given anesthesia to the clearing of the sinuses to when the patient is advised to go.
Unlike existing balloon sinuplasty devices which use a guidewire for inserting the balloon dilator into the nose till it reaches a clogged cavity, SinuCare has provisioned for ENT doctors to mount their endoscopic camera for a clear view of the sinuses and blockages. A guidewire is a polymer wire that is put alongside/inside the dilator to allow the doctor to feel the sinus blockage. However, it increases the cost of the device, the number of components it comprises, and the skill requirement to carry out the procedure.
The other key different feature of SinuCare is that its guiding system is a reusable product. The double-balloon dilator is the only disposable material in SinuCare whereas other sinuplasty devices are completely disposable. Without the dilator, SinuCare can be completely sterilized for reuse, enabling reduction of the total cost of the device for the doctors as well as that of the overall treatment.
Currently, SinuCare is being recommended and used by co-inventor Dr. Sunil Narayan Dutt, world renowned Otolaryngologist and Head of ENT at Apollo Hospitals, Bangalore and by Dr. P.S. Pradeep Kumar, Founder and Medical Director, Meenakshi ENT Specialty Hospital, Bangalore. They have been contributing feedback in the making of SinuCare.
The product is being packaged as a kit that comprises the main device, three dilators, and a pressure pump. SinuCare kit is priced at approximately Rs. 30,000 for the ENT doctors, and the treatment cost ranges between Rs. 40,000 and Rs. 60,000.
While the guiding system of SinuCare has been designed and manufactured in India, the disposable double-balloon dilator for it, also designed in India, is being contract manufactured by Surmodics in Ireland. “We want Indian manufacturers to come forward and create good quality products for us. Under the government’s Make in India initiative, we are trying to manufacture devices in India – one for giving business within the country and second to minimize the cost. The manufacturing scope is big in the field of medical devices. However, we are yet to see innovative manufacturers who are willing to work with a development team, experiment with business models and to give the same quality as foreign suppliers,” says Pooja Kadambi, the team’s lead engineer and co-inventor who has significantly contributed in designing and manufacturing of SinuCare.
ENT doctors, patients with chronic sinusitis, and manufacturers can write to Dr. Jagdish Chaturvedi at email@example.com or call 080-40923864.