Respiratory Sounds

A new therapy for nasal septal deviation builds on decades of polydioxanone research and development. By James Kintzing and Dr. Brandon McCutcheon, Spirair When we founded Spirair and began developing SeptAlign — a novel therapy designed to mechanically correct nasal septal deviation (NSD) — we knew we needed to find a material that could hold the nasal septum under tension long enough for cartilage remodeling but also resorb within an appropriate time frame. We ultimately chose polydioxanone (PDO), which has been widely used for decades for medtech applications spanning from plastic surgery to orthopedics to cardiology. As we refined SeptAlign and prepared to bring it through clinical research and regulatory review, PDO became a clear choice over many other materials that bring healthcare innovation to life. The challenge As co-fellows in the Stanford Biodesign Innovation Fellowship, we spent months in clinical settings observing processes and patient care to identify a list of areas with significant unmet needs. We were drawn to the ear, nose and throat (ENT) specialty, where we observed ENT physicians increasingly using minimally invasive technologies with the potential to broaden the reach of patient care and often enable treatment in the physician’s office rather than the OR. We discovered that NSD was one of the last areas in the space that did not have a minimally invasive treatment approach, despite being one of the most common problems seen by ENTs. NSD is one of the most common causes of nasal airway obstruction (NAO), a condition that makes it difficult to breathe through the nose. Nasal airflow is massively impacted by the diameter of the airway. Even a very small deviation in the anterior of the nose where airflow is most restricted can significantly impact nasal breathing. While most people have a deviated septum to some degree and may not require medical intervention, millions of people in the U.S. are symptomatic enough to seek ENT care annually. People with this condition may experience difficulty breathing out of one or both nostrils, headaches, facial pain, nasal congestion, noisy breathing, nosebleeds, chronic sinusitis, snoring and dry mouth. Traditional septoplasty or septorhinoplasty are the most common open surgical options for NSD. While effective, these procedures are invasive and can require significant downtime, with some patients requiring two weeks or more to recover. These learnings presented us with an unmet need among people living with NSD and NAO and an opportunity to develop a solution. Finding the right absorbable polymer We started imagining how we could effectively correct NSD in a much less invasive way than existing surgical procedures. We thought about this similarly to how a gardener trains a tree or flowers to grow vertically, providing the needed structural support until they can grow upright and flourish on their own. Unlike training trees and flowers, mechanically correcting NSD requires more careful material selection. We knew we needed a material with appropriate tensile strength, biocompatibility, and a resorption time matching the time needed for the cartilage to heal. It was also important to find a well-characterized material with well-studied mechanism of predictable degradation. The goal with absorbable polymers is to have resorption time match the use case, which requires a careful balance. A mismatch between absorption time and the time needed to heal could increase the risk of complications in this type of procedure. PLLA (poly-L-lactic acid) and PDLA (poly-D-lactic acid) copolymers have been used in other ENT applications such as lateral wall implants, which support the wall of the nose to prevent lateral wall collapse during breathing. These materials are effective in certain use cases, but we knew they would resorb too slowly for our purposes. Similarly, poly(DL-lactide-co-glycolide) (PLGA) copolymers have been used successfully in other ENT applications including sinus implants, which are inserted into the sinus opening to maintain patency after sinus surgery. Again, PLGA can be effective in these applications, but we knew that it would resorb too quickly to be an effective material for SeptAlign. Chosing polydioxanone for a bioabsorbable implant After reviewing other materials used in similar applications, we landed on our “Goldilocks” solution and selected polydioxanone (PDO) as the material that would make up SeptAlign’s bioabsorbable implant. PDO maintains sufficient tensile strength for at least six to 10 weeks, which is also the time required for cartilage remodeling. It also fully resorbs within six months, making it well suited for mechanical correction of NSD. This material has been used in other applications outside of ENT for decades, including orthopedics, plastic surgery and cardiology. These applications have shown PDO’s safety and efficacy, and we knew we could build on its decades of success by using it in a new way with NSD correction. Our early clinical research demonstrated that the cartilage can maintain its new shape after being held under tension by absorbable implants. When compared on a weight basis to other polymers commonly used in ENT such as poly(lactic acid) (PLA) and poly(glycolic acid) (PGA), PDO degradation products are less acidic, which could cause less of an inflammatory reaction during resorption. Looking ahead Innovation can often be catalyzed by reimagining the familiar. As we look to the future, innovation at Spirair will continue to draw inspiration from everyday materials, methods, and mechanism. SeptAlign received FDA clearance in March 2024, and we are beginning a limited rollout before larger-scale commercialization later this year. We are looking forward to sharing additional data from our ongoing clinical research and updates on SeptAlign as we bring it to more physicians and patients across the country. James Kintzing, Spirair co-founder and chief technology officer, is a bioengineer, entrepreneur, and inventor of technologies spanning applications from polymer chemistry to cancer therapeutics to medical devices. He completed the Stanford Biodesign and Innovation Fellowship in 2020. Dr. Brandon McCutcheon, Spirair co-founder and chief medical officer, is a neurosurgeon, inventor, medical device entrepreneur, and author on over 40 peer reviewed publications. He completed the Stanford Biodesign and Innovation Fellowship in 2020. How to submit a contribution to MDO The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

TUESDAY, Aug. 1, 2023 -- Pediatricians have suspected it for years, and now a new study may be proving them right: Cold air really can help ease children's croup symptoms. Croup is a common childhood illness that usually starts as an ordinary cold. It arises when the infection causes swelling around the voice box (larynx) and wind pipe (trachea), leading to some distinctive croup symptoms: a cough that sounds like a seal's bark and a high-pitched "creaky" or whistling noise when a child inhales (what doctors call stridor). Fortunately, most cases of croup are mild. And pediatricians have long told parents they can try some old-fashioned tricks for milder croup symptoms: running a hot shower and standing with their child in the steamy bathroom; standing in front of an open refrigerator freezer, or wrapping their child in blankets and going outside in the chilly air for a bit. "The common denominator there is the moist air," said Dr. Mike Patrick , an emergency medicine physician at Nationwide Children's Hospital in Columbus, Ohio. "Indoor air, especially in the winter, is dry." He said pediatricians were giving that advice back when he was a resident almost 30 years ago. There is a basis for it, Patrick and other pediatricians said. There is a "classic" croup scenario where a child develops worsening symptoms at night and worried parents rush the child to the ER. "But by the time they get there, the symptoms are getting better," said Dr. Matthew Harris , an emergency physician at Cohen Children's Medical Center in New York. It seems that just a short time in the cool air can be helpful, Harris said. A new study, published online Aug. 1 in Pediatrics, put that belief to the test. The research was conducted by Dr. Johan Siebert and colleagues at Geneva Children's Hospital in Switzerland. They recruited families who were bringing their baby or young child to the ER because of croup symptoms. If the symptoms were mild to moderate, the families were randomly assigned to one of two groups: one where children were given the oral anti-inflammatory drug dexamethasone and then spent 30 minutes outside in the chilly air; and one where kids received dexamethasone and stayed inside the ER. None of the children had severe symptoms, such as persistent stridor, even at rest, or difficulty breathing. In those cases, it's standard to give inhaled epinephrine to open up the airways quickly, Patrick said. Overall, the study found, cold air was helpful for at least some kids. Of 59 children exposed to outdoor air, 49% had a substantial improvement in symptoms by the 30-minute mark. That compared with about 24% of 59 children who stayed indoors. However, the findings do not mean that ERs should start sending families out into the ambulance bay to manage a child's croup symptoms. For the study's purposes, the ER served as a controlled setting to observe the effects of cold air exposure, Harris and Patrick said. Instead, they said, pediatricians can see the findings as evidence for some benefit of the practice. "What's cool about this study is, it brings this into the realm of evidence, and not just anecdote," Patrick said. Dr. Joanne Nazif , of Children's Hospital at Montefiore in New York City, agreed that the study offers "some evidence" in support of cold air. But she also stressed that the researchers tested it in combination with dexamethasone -- not as a stand-alone. And cold air did not always help, Nazif noted. If parents have any worry about their child's breathing, Nazif said, they should seek care. But, she added, "you might want to crack the car window open on the way to the ER." Sources Michael Patrick, MD, emergency medicine physician, Nationwide Children's Hospital, assistant professor, clinical pediatrics, Ohio State University College of Medicine, Columbus, Ohio Matthew Isaac Harris, MD, emergency physician, Cohen Children's Medical Center, New York City Joanne M. Nazif, MD, attending physician, Children's Hospital at Montefiore, assistant professor, clinical pediatrics, Albert Einstein College of Medicine, New York City Pediatrics, September 2023 Posted August 2023

Singaporean medical technology firm Aevice Health and the National University Health System have announced their partnership to conduct a clinical trial of the former's wearable respiratory monitor. The AI-powered wearable stethoscope AeviceMD remotely detects and records chest sounds at the same time. The sounds are then analysed and translated into heart rate and respiratory rate measurements while flagging abnormalities such as wheezing. WHY IT MATTERS NUHS noted that one in five children in Singapore has asthma, one of the most prevalent chronic diseases affecting 14% of children worldwide. The condition can be "difficult to manage" when children are not able to communicate their symptoms or realise they are experiencing them, leading to "under-diagnosis, under-treatment and inadequate control of the disease". The healthcare group, through its Centre for Innovation in Healthcare, will investigate the use of AeviceMD in detecting wheezing, one of the key signs of asthma, in children patients with breathing difficulties at the National University Hospital. It already recruited participants in September and is targeting to finish the study by the second quarter of 2022. Dr Michael Lim, the study's principal investigator, said the respiratory monitor by Aevice Health "can potentially enhance remote patient monitoring and may be useful in situations such as the current COVID-19 pandemic where there is a need to minimise contact with patients. The NUH senior consultant also pointed out that its "ability to detect abnormal lung sounds may also find usefulness in homes to identify wheezing early in children and allow for prompt attention by the caregiver". THE LARGER TREND Aevice Health is also researching and developing a predictive model for asthma attacks in paediatric patients using a wearable continuous monitoring device. In other news, the company in June secured over $2 million in a pre-Series A funding round joined by Toho Holdings and SEEDS Capital of Enterprise Singapore, among others. The proceeds from the investing event were set aside for the development of its respiratory monitoring solution and its entry into Japan. Aevice Health has entered into a strategic partnership with medical products wholesaler Toho Holdings to market AeviceMD in Japan. ON THE RECORD "This study will further validate AeviceMD’s value to providers and patients by empowering the detection of lung sound abnormalities objectively, continuously, and remotely to further bridge the gap between providers and clinicians," said Aevice Health CEO Adrian Ang. "The use of AeviceMD as a novel remote respiratory monitor can unlock insights beyond the hospital for providers to better understand factors leading up to an exacerbation to allow for more tailored and patient-centred outcomes. We are excited by how the use of the AeviceMD can enhance the way chronic respiratory diseases [are] being treated and understood," he added.