Nosealign

Intended Use

NoseAlign^® is a medical-grade silicone cleft nose approximation device that provides gentle support to the soft tissue of the nose and approximates the displaced soft tissue of the nose and alveolus in patients born with cleft lip prior to primary lip and nose surgery.

Indication of Use

NoseAlign^® device can be used in the nostril for patients born with unilateral and bilateral cleft lip prior to primary lip and nose surgery

To support the collapsed upper and lower nasal cartilages

To support the displaced columella of the nose

To support the deviated nasal septum

To approximate the displaced nasal alar bases

To approximate the displaced alveolar segments

The NoseAlign^® devices are used by prescription only and under the supervision of a licensed physician or a dentist. The NoseAlign^®device can be used starting one week after birth up to the first primary reconstruction surgery of the lip and nose. OTC medical adhesive tapes are used to secure the device to the face. The device is discontinued immediately after the primary repair of cleft lip and nose. The NoseAlign^® device is only sold to a licensed physician or dentist.

NoseAlign^® device is "Patent Pending"

The NoseAlign^®device can be used starting one to two weeks after birth up to the first primary reconstruction surgery of the cleft lip and nose. The NoseAlign^® device is secured to the cheeks with a stick-to-skin NoseAlign^® Cheek Fastener and orthodontic elastics (5/16” or ¼” 2 oz or 3.5 oz) (both sold separately). Alternatively, Over-The-Counter (OTC) 3M Steri-Strip (purchased separately) can also secure the NoseAlign^® device to the cheeks.

The NoseAlign^® device can be used daily for 20-22 hours and the device must be removed for cleaning at least twice a day.

The NoseAlign^® device is available in 3 different sizes and the treating provider will usually start with NoseAlign^® device size # 1. The treating provider will also decide to change it to size #2 and #3 in the 2nd and 3rd months respectively. Each size of the device is used for no more than 4 weeks.

No dental impression is needed as the device is prefabricated
No need for a dental laboratory for the device adjustment
NoseAlign^® device supports the displaced soft tissue nasal structures within the first 2 weeks to take advantage of the plasticity of the nasal soft tissue and the cartilage (Matsuo and Hirose 1988)
Easy for the caregiver to use
No intraoral plate, so no interference with the feeding
No potential for developing intraoral sores
No risk of creating mega nostril
Reduces the number of office visits, therefore ideal for patients living far from the cleft centers
Optimizes conditions for primary cleft surgeries

Matsuo, K. and T. Hirose (1988). "Nonsurgical correction of cleft lip nasal deformity in the early neonate." Ann Acad Med Singap 17(3): 358-365.

An infant with a complete left-side unilateral cleft lip and palate is depicted in the pre-NoseAlign insertion photo, revealing a flattened left nostril rim, collapsed columella, a deviated nose to the right side, and significantly separated alveolar segments and lips. In contrast, the left photo displays the insertion of the NoseAlign device, size #3 (size # 1 was used for 2 weeks, and #2 was used for 4 weeks before the insertion of #3). Notable improvements include support to the left nostril rim, uprighting of the collapsed columella, straightening of the nose, and approximation of the alveolar segments and lips. The NoseAlign #3 device is scheduled for use over a 4-week period, leading up to the infant's primary reconstruction surgery at 3 months.

Your treating surgeon will assess whether your child is a suitable candidate for the NoseAlign device. If deemed eligible, your treating physician or dentist will then proceed to insert the NoseAlign device, starting with size #1, approximately 2 weeks after birth. To secure the device to the face, a combination of orthodontic elastics and medical adhesive tapes is employed. The treating physician or dentist will meticulously determine the optimal elastic tension for your child. The device is used for around 2 weeks, with a requirement for 22 hours of daily wear. Additionally, it is removed 2-3 times a day to facilitate cleaning and maintain hygiene.

The transition to the NoseAlign device size #2 takes place during the second month, following the use of size #1. Your treating physician or dentist will assess and decide when your child is ready to switch to the new size. To affix the device to the face, orthodontic elastics and medical adhesive tapes are utilized, with the treating physician or dentist determining the suitable elastic tension for your child. The size #2 NoseAlign device is employed for approximately 4 weeks, requiring 22 hours of daily wear. Additionally, the device is removed 2-3 times a day to facilitate cleaning and ensure hygiene.

The NoseAlign device transitions to size #3 after the use of size #2 during the third month. Your treating physician or dentist will make the determination of when your child is ready to switch to the new size. The device is affixed to the face using orthodontic elastics and medical adhesive tapes, with the treating physician or dentist adjusting the elastic tension as needed. The size #3 NoseAlign device is utilized for approximately 4 weeks, requiring 22 hours of daily wear. Additionally, the device is removed 2-3 times a day for cleaning and hygiene. Importantly, the device is discontinued immediately after primary reconstruction surgery.

NoseAlign® device is "Patent Pending"

NoseAlign^® device is "Patent Pending"