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Device Technologies and Biomedical Robotics

Device Technologies and Biomedical Robotics - Poster Session E

Poster V18 - Device to Improve Nasal Splinting Process to Enhance Post-Surgical Recovery

Saturday, October 26, 2024
10:00 AM - 11:00 AM EST
Location: Exhibit Hall E, F & G

Introduction:  Following a rhinoplasty, nasal splints are used to ensure structural protection and proper healing of the nasal region. Current methods of conforming a nasal splint require the surgeon to form the material directly onto the patient’s nose; however, with inflammation and fragile cartilage this method can cause nasal structural damage and an extended period for healing.
Surgeons need a solution that allows nasal splints to be molded without placing pressure on the patient’s nose post-surgery to minimize deviation in nasal structure and patient discomfort. This study developed a novel device that is comprised of three components made of acrylonitrile butadiene styrene: a nasal bridge portion and two wings with intersecting structures that are connected via steel machine screws. The surgeon first uses this device to obtain the angle (created by the nasal structure and the sagittal plane) from the patient by securing the device flush to the nasal bridge. After locking the device in place, the surgeon can then use the inside of the device to conform the nasal splint to the patient’s specific nasal bridge dimensions. The nasal splint can then be removed from the device and placed on the patient’s nose. Modeling of the device using Fusion 360 is shown in provided images.
The impact of this design lies in enhancing patient outcomes through reshaping nasal splinting procedures. This innovation not only addresses the existing challenges in nasal splinting but also sets a new benchmark for efficiency, safety, and patient satisfaction in the field of otolaryngology.

Materials and

Methods:  Accuracy and precision in nasal measurement and molding data was collected through MATLAB code. Using image processing within MATLAB, a side profile and front view picture of multiple subjects gave data of these two measurements. The same picture was taken of the formed nasal splint using our device, and the equivalent data was extracted from these photos.
For any biological measurement, there is inevitable variability. To ensure that all noses are compatible with the nasal splinting device, a random sampling of patients' scans was analyzed using MATLAB software, to determine the range of nasal dimensions. The MATALB code determined the distance between two preselected points on a CT scan. This process was completed for several measurement positions. The data was used to determine the sizes that would be needed for the nasal splints while offering 80% biological variability
Drop tests from a height of 1.3 meters, the height of a standard operating table in an OR, were performed and assessed. The device was determined to be able to withstand 10 drops from this height without any deformation or cracking. Stress simulations were performed using Fusion 360 to quantify the force needed to deform the device at the locking mechanism.
To validate the device, a series of comprehensive testing was conducted. Otolaryngology Surgeons were asked to use the device during a rhinoplasty procedure to give feedback for device impact on duration time of procedure, comfort for patient, and likeliness of use. The surgeons were given these questions in a survey format.

Results, Conclusions, and Discussions: For accuracy and precision of the device, there was a less than 10% deviation between the two angles measured. Comparison of these measurements verified the accuracy and precision of the device’s capability in forming the nasal splint because there was no statistically significant difference.
The results of the variability test indicated that the four sizes of the device and Denver Nasal Splints would accommodate 95% biological variability. This data verified the device’s capability to accommodate a range of different nasal shapes and sizes.
The device passed the durability verification because no deformation or cracking occurred in the device’s overall structure after 10 drops, and only cracked on drop 16. It was also determined that the force needed to deform the device at the locking mechanism was equal to 0.15 MPa and this can be shown in the image of the stress simulation provided.
The surgeon survey responses determined the average rating of device usability was an 8/10. The surgeons also stated that they are very likely to use the device for future procedures. Furthermore, the results of the procedure time duration validation test showed that the device did not decrease the efficiency of the surgeon, and time duration average was less than 5 minutes.

Conclusion:
The device functions to measure an individual's nose for the splinting process. The device accomplishes the measurement by determining the angle created by nose and the longitudinal axis. Given the device’s ability to accurately create a mold of the patient’s nose it fulfills the requirement that the patient not be directly involved in the molding process of the nasal splint.
Advancements can be made in the manufacturing process by utilizing blow molding techniques, enhancing the device's strength and durability. Efforts can also be made to increase compatibility with other brands of nasal splints, broadening its application across the medical field. These studies were only done with Denver Nasal Splints. Comprehensive clinical testing can be undertaken with a wider spectrum of surgeons to gather a diverse range of insights. Furthermore, the exploration of alternative locking mechanisms could improve device security and ease of use.

Acknowledgements (Optional):  Lara van Heerden Co-Author
Daniel Brown Co-Author
Georgia Hill Co-Author
James Huang Co-Author
Joel Bumgardner PhD Final-Author
Carl Herickhoff PhD Primary Investigator