Nasal Stent Research Articles

Personalized Bioactive Nasal Supports for Postoperative Cleft Rhinoplasty

After cleft lip and palate surgical procedures, patients often need nostril supports to help the reconstructed nostrils retain their shape during healing. Many postoperative nasal stents use a one-size-fits-all approach, in which a standard rubber tube retainer is trimmed and used to support the healing nares. The purpose of this study was to examine photogrammetry and 3-dimensional (3D) printing as a fabrication tool for postoperative patient-specific nasal supports that can be loaded with bioactive agents for localized delivery. A "normal" right nostril injection mold was prepared from a left-sided unilateral cleft defect, and the negative-space impression was modeled using a series of photographs taken at different rotation angles with a commercial mobile phone camera. These images were "stitched" together using photogrammetry software, and the computer-generated models were reflected, joined, and digitally sculpted to generate hollow bilateral supports. Three-dimensional prints were coated with polyvinylpyrrolidone-penicillin and validated for their ability to inhibit Escherichia coli using human blood agar diffusion assays. The results showed that our approach had a high level of contour replication and the antibiotic coating was able to inhibit bacterial growth with a mean zone of inhibition of 15.15±0.99mm (n=9) (P<.0001) in disc diffusion assays. Consumer-grade 3D printing displays potential as a fabrication method for postoperative cleft bilateral nasal supports and may support the surgically reconstructed internal contours. The results of this study suggest that such types of bioactive 3D prints may have potential applications in personalized drug-delivery systems and medical devices.

Modifications in Presurgical Nasoalveolar Molding Treatment of Bilateral Cleft Lip and Palate Patients With Severely Malpositioned Premaxillae.

The aim of this study was to evaluate a modified presurgical nasoalveolar molding (PNAM) treatment for patients with bilateral cleft lip and palate (BCLP) with severely malpositioned premaxillae. This study was conducted at the Faculty of Dentistry, Department of Orthodontics, Ege University, Bornova, Izmir, Turkey. Retention arms were manufactured using a mold that we developed, and prefabricated retraction apparatuses were applied to the plaster model obtained from the patient. During the acrylic curing process, the flanges of the appliances were elongated into the sulcus without including the premaxilla. The premaxilla was aligned with the midline with an elastic band system, and the lip hanger was constructed with 0.023-in stainless steel wire. Elastic bands were stretched between the retraction apparatuses and the lip hanger based on the desired force. Nasal stents were added to the retention arms when the cleft width was reduced to less than 6 mm. The modified PNAM treatment enabled faster derotation of the premaxilla and earlier initiation of retraction. The prefabricated retraction apparatus and retention arm provided efficient PNAM for patients with BCLP.

Effectiveness of presurgical nasoalveolar molding therapy on unilateral cleft lip nasal deformity.

Objectives:To evaluate the effectiveness of pre-surgical nasoalveolar molding (PNAM) in patients with unilateral cleft lip nasal deformities.Methods:This was a retrospective study involving 29 patients with unilateral cleft lip and palate defects, of whom 13 were treated with palatal devices with nasal stents (PNAM group) and 16 were treated with palatal devices without nasal stents or surgical tapes (control group). Submental oblique photographs and orthodontic models were longitudinally obtained at the initial visit (T1) and immediately before (T2) and after cheiloplasty (T3). Asymmetry of the external nose, degree of columellar shifting, nasal tip/ala nose ratio, nasal base angle, interalveolar gap, and the sagittal difference in the alveolar gap were measured. The study was conducted in the Orthodontic Clinic at Tokushima University Hospital, Tokushima, Japan between 1997 and 2012.Results:At T1, there were no significant intergroup differences in the first 4 asymmetry parameters. At T2, the PNAM group showed a significant improvement in all values compared to the control group. At T3, the PNAM group showed significant improvement in nasal asymmetry and columellar shifting. Model analysis showed significantly greater changes in the inter-alveolar gap and the sagittal difference of the alveolar cleft gap from T1 to T2 in the PNAM group.Conclusion:The use of PNAM is indispensable for pre-surgical orthodontic treatment at the early postnatal age.

Primary Repair in Patients With Unilateral Complete Cleft of Lip and Primary Palate: Assessment of Outcomes.

Asymmetry of median facial structures is a major concern for patients with unilateral cleft lip and palate, and the principal goal of its treatment is to restore symmetry. Unilateral complete cleft of lip and primary palate (UCCLPP) is an uncommon subgroup and rarely reported. Patients with UCCLPP have protruding and deviating premaxilla, rendering a primary repair difficult. This study evaluated consecutive patients with UCCLPP and presented their treatment outcome. We assessed 36 patients with UCCLPP and collected clinical information. Surgical repair was performed at 3 months of age by using a modified rotation-advancement method and primary nasal reconstruction. A single surgeon performed all surgical procedures. A postoperative nasal stent was used for 6 months. Follow-up standardized photographs were collected. Landmarks were identified, and nose and lip dimensions measured. The ratios of the corresponding parameters (cleft vs noncleft side) were obtained for evaluating nose and lip symmetry. No surgical complication was noted in any patient. The overall lip and nose outcome after the primary repair were adequate, and all ratios were close to 1. The nostril width was slightly wider on the cleft side, but the alar width and height were acceptable. The lip heights were balanced between the 2 sides. Patients who received presurgical nasoalveolar molding did not show more favorable lip and nose dimensions, except for the medial philtral height. Even in the presence of protruding and deviating premaxilla, our patients with UCCLPP obtained adequate lip and nose outcome after undergoing primary lip repair and nasal reconstruction.

The Use of 3D Printing in the Fabrication of Nasal Stents

Nasoalveolar molding of the cleft lip, nose, and alveolar palate has been a successful strategy for the restoration of oronasal function and appearance, but it has some drawbacks. The temporary implant that is inserted before surgical reconstruction is a large appliance requiring numerous adjustments, it can irritate delicate soft tissues, and interfere with the infant’s ability to nurse or feed. In the early post-operative period and for months after cleft lip repair, patients wear standardized silicone stents that come in multiple sizes, but require significant sculpting to fit the unique cleft deformity. Three-dimensional (3D) printing offers the potential of highly personalized and patient-specific treatment. We developed a method that produces a customized 3D printed stent that matches the contours and unique features of each patient and permits modification and adjustments in size and shape as the patient ages. With 3D scanning technology, the device can be designed at the first visit to create an appliance that can be worn sequentially with minimal trauma, does not impede feeding, and a prosthesis that will improve compliance. The device will be worn intraorally to help shape the alveolus, lip, and nose before surgical repair. Furthermore, the stent can be doped with drugs as each patient’s case warrants.

Can overnight stenting be safely eliminated following a pharyngeal flap? A matched comparison study.

Determine if overnight stenting is warranted after pharyngeal flap for management of velopharyngeal insufficiency (VPI) in pediatric patients METHODS: This is a retrospective age-matched cohort study from a single tertiary pediatric facility. Patients who underwent a posterior pharyngeal flap for VPI from January 1, 2013, to December 31, 2016, were included. Two equal groups were constructed based on when their nasal stents were removed, that is, postoperative day (POD) 0 or POD 1. Primary outcome measure was oxygen desaturation after surgery. Secondary outcome measures were total length of stay, need for narcotics, and oral intake based on POD. Additional information was gathered and evaluated as possible prognostic variables. There were 27 matched pairs included in the study. One patient from each group required supplemental oxygen during the night of surgery. No escalation of care was needed in either case. The group whose stents were removed on POD 0 were discharged earlier than the group whose stents were removed on POD 1, P < 0.0001. The POD 0 group took significantly more oral intake on POD 0 than the POD 1 group, P = 0.03. The POD 0 group had significantly more genetic syndromes than the POD 1 group, P = 0.02. There was no benefit with overnight stenting. Earlier discharge from the hospital was achieved in the POD 0 group. No patient experienced need for reintubation, escalation of clinical care, postoperative hemorrhage, or death. 4. Laryngoscope, 128:750-755, 2018.

Expand pedicle forehead flap in the repair of whole nasal defect

Objective:To observed the application of expanded pedicle forehead flap in nasal defect. Method:Totally 11 whole nasal defect cases in our department from June 2010 to March 2016 were treated with the expanded pedicle forehead flap. Regular follow-up was performed after operation to observe the survival condition of flaps, shape, color, texture and scar in donor site after nasal repair. Result:The expanded pedicle forehead flap and transplantation of autologous costal cartilage nasal stents were all survived, the reconstruction nasal shape was satisfied. After 1-5 years follow up, the repair using expanded forehead flap had a good color with enough blood supply, and the nasal ventilation function is well. There was only one linear scar leaved in donor site. Conclusion:Application of the expanded pedicle forehead flap is a good mothed for the treatment of whole nasal defect.

Choanal Atresia: Birth Without Breath

Bilateral Choanal atresia is a medical emergency. Corrective surgery is the mainstay of the treatment. Hegar's dilator was used in all cases to break the bony/membranous atretic plate. The 22 cases of choanal atresia all operated by the first author were included in this study. Eight cases were 1-5year old with bilateral choanal atresia and all required immediate surgery as they had repeated attacks of respiratory distress and cycle of cyanosis. Eight cases were of CHARGE Syndrome. All the cases were operated under general anaesthesia. Hegar's dilators were used and nasal stents were placed in all cases. Although complete nasal patency was achieved by surgery, in 8 cases, neonates could not survive due to the CHARGE Syndrome. The mortality was unrelated to the surgery. The 14 cases which were not related to CHARGE Syndroma had a good postoperative recovery. 3 cases were above 15years old with unilateral complete bony/membranous choanal atresia and they presented with continuos nasal discharge. Hegar's dilators are a safe and simple method of surgery for choanal atresia. Nasal stenting is mandatory to prevent restenosis.

Compatible Biomaterials Used In Rhinology Surgery – Our Expertise

Abstract In the last decades, rhinology has developed in a great manner concerning new surgical techniques and extending the use of compatible biomaterials in order to achieve normal morphology and normal functional aspect after surgery (endoscopic or open approach). Since biomaterials are integrated in biological active organs and systems, they have to be easily accepted by the receiver with no toxicity, inflammation or other side effects. The authors try to review all biocompatible materials used in several rhinological pathologies in order to obtain the best results after functional or reconstructive surgery. In rhinological surgery there are usually used homograft’s but the use of biomaterials like alloplastics (silicone, high density polyethylene, polytetrafluoroethylene, etc.) has widely increased. The authors present their experience in endoscopic approach of choanal atresia using nasal stents, closure techniques for septal perforation using nasal splints, endoscopic drainage and sinus ventilation using balloon sinuplasty, lacrimal pathway obstruction using double margin stent and some materials used in cosmetic and reconstructive rhinoplasty.

The role of Nasoalveolar molding: A 3D Prospective analysis

Nasoalveolar molding (NAM) is commonly employed to reduce the alveolar segments into proper alignment and to improve nasal symmetry in patients with cleft lip and palate. This study examines the periodical progression of NAM treatment over time. 20 patients with complete unilateral cleft lip and palate were prospectively recruited. A 2 stage NAM treatment protocol was applied. Stage 1 involved adjustment of the alveolar segments (mean age 15.6 days), while Stage 2 added nasal stents and started average 43 days after stage 1. 3D images (n = 241) were obtained prior to NAM initiation and weekly until the end of treatment. The cleft lip area, bilateral nostril areas, and the nostril height and width were measured. Treatment was assessed in the Cleft (C) side and the Non-cleft (N). There was significant difference in the C/N ratio of the nostril area, width, and height at pre-treatment (0.9 ± 0.3, 4.1 ± 1.1, and 0.5 ± 0.2), at the end of stage 1 (1.1 ± 0.3, 2.2 ± 0.6, and 0.8 ± 0.2), and at the end of stage 2 treatment (1.8 ± 0.3, 1.8 ± 0.4, and 1.2 ± 0.1); p < 0.05. Comparative 3D analysis with dense sampling offers a precise methodology for showing effects of NAM treatment. The morphological changes achieved with NAM therapy occur in early treatment phase.

RapidNAM: generative manufacturing approach of nasoalveolar molding devices for presurgical cleft lip and palate treatment.

Nasoalveolar molding (NAM) is an accepted treatment strategy in presurgical cleft therapy. The major drawbacks of the treatment listed in the literature relate to the time of the treatment and the coordination of the required interdisciplinary team of therapists, parents, and patients. To overcome these limitations, we present the automated RapidNAM concept that facilitates the design and manufacturing process of NAM devices, and that allows the virtual modification and subsequent manufacture of the devices in advance, with a growth prediction factor adapted to the patient's natural growth. The RapidNAM concept involves (i) the prediction of three trajectories that envelope the fragmented alveolar segments with the goal to mimic a harmonic arch, (ii) the extrusion from the larger toward the smaller alveolar segment along the envelope curves toward the harmonic upper alveolar arch, and (iii) the generation of the NAM device with a ventilation hole, fixation pin, and fixation points for the nasal stents. A feasibility study for a vector-based approach was successfully conducted for unilateral and bilateral cleft lip and palate (CLP) patients. A comparison of the modified target models with the reference target models showed similar results. For further improvement, the number of landmarks used to modify the models was increased by a curve-based approach.

Clinical study of 19 patients with congenital choanal atresia after surgery and nasal stenting

Clinical study of 19 patients with congenital choanal atresia after surgery and nasal stenting

Pilot Study of Oral Negative Pressure Therapy for Obstructive Sleep Apnea-Hypopnea Syndrome

Background: Although the continuous positive airway pressure is the gold standard therapy for patients with moderate to severe obstructive sleep apnea-hypopnea syndrome (OSAHS), there are several treatment options such as mandibular advancement devices, tongue-retaining devices, and nasal airway stent devices. Recently, newly developed intraoral pressure gradient therapy system, iNAP® Sleep Therapy System, was introduced as an alternative treatment for OSAHS patients. Purpose: This feasibility study explored the effectiveness of the iNAP® device for patients with mild to moderate OSAHS. Materials and Methods: The iNAP® device consisted of an oral interface, a tube set with a saliva container, and a negative pressure console. Negative pressure is introduced directly from the oral interface and the pressure pulls the tongue anteriorly, resulting in improving the obstruction or narrowing of the upper airway. A total of 5 male and 4 female patients with mild to moderate OSAHS, aged between 32 and 62, with 50.6 years ± 11.7 years were recruited in the study. Results: The baseline apnea-hypopnea index (AHI) was 17.2 events per hour ± 4.7 events per hour, while AHI with the iNAP® device was 12.7 ± 5.4 (p<0.01). Regarding the sleep architecture, a significant reduction in wakefulness after sleep onset (WASO) on the initial night of treatment from 97 min ± 50.0 min to 70.7 min ± 36.9 min (p<0.05) was observed; however, other sleep parameters were not. Conclusion: This study demonstrated that negative pressure therapy with the iNAP® device improved the apnea severity in patients with mild to moderate OSAHS, the degree of whose amelioration of AHI was marginal but significant. Although the number of patients recruited was small, this study is the first report on the effectiveness of the intraoral pressure gradient therapy.

Congenital nasal cavity stenosis in children with craniosyntosis: A report of 4 rare cases

Congenital bony nasal stenosis (CBNS) is a very rare but life-threatening cause of airway obstruction in neonates and infants. This review aims to assess the presentation and early airway management of 4 new cases of craniosynostosis with bilateral nasal cavity stenosis. Patients were treated with endoscopic endonasal widening of the nasal cavity and stenting. All patients were extubated well post-operatively with resolution of symptoms. They remained asymptomatic with stents in situ for at least 6 months with no complications reported.Minimally invasive endoscopic endonasal widening of the nasal cavity with stenting is an effective and safe way of addressing nasal cavity stenosis.

Effect of the type of surgery, use of intraoperative topical mitomycin C or stenting on the outcome of choanal atresia repair: a systematic review and meta-analysis

Abstract Restenosis and recurrence of symptoms after posterior choanal atresia (CA) repair is a major concern for surgeons, which leads to the use of a variety of surgical approaches and adjuvant treatment modalities to avoid restenosis. The study was designed to compare the outcome of transnasal endoscopic and transpalatal repair of CA as regards restenosis, and also to compare the effect of using topical mitomycin C (MMC) or nasal stenting with not using these modalities on the outcome of repair as regards restenosis. A systematic search was conducted on the PubMed/MEDLINE to locate and select relevant studies without applying any limits. Studies included in meta-analysis were tested for heterogeneity of the estimates. As regards comparing the transnasal endoscopic and transpalatal approaches, eight studies, involving 410 cases, met our criteria; 197cases were repaired endoscopically with 37.5% restenosed and 188 through transpalatal approach with 28.2% restenosed. Using the estimated odds ratio, no statistically significant difference was found as regards restenosis. For the use of MMC, five articles fulfilled our criteria; they involved 155 cases; MMC was used in 70 cases where 24.2% restenosed, and was not used in 85 cases where 35.2% restenosed. By estimated odds ratio, there was no statistically significant difference between the two groups as regards restenosis. For the use of stenting, four articles fulfilled our criteria; they involved 165 cases, out of which 93 cases used nasal stent after repair of CA (21.5% restenosed), whereas in 72 cases stent was not used (18% restenosed). By estimated odds ratio there was no statistically significant difference between the two groups. The available evidence suggests that there is no statistically significant difference between transnasal endoscopic and transpalatal approach in the repair of CA as regards restenosis; furthermore, there is no statistically significant difference between using intraoperative topical MMC and nasal stent and not using such modalities on the outcome of CA repair.

Changes in Nasal Configuration Following Primary Rhinoplasty: Direct Anthropometric Measurement in Patients With Complete Unilateral Cleft Lip and Palate.

With the recent advances of surgical adjuncts including presurgical naso-alveolar molding and postoperative nasal stenting, information on the anthropometric evaluation of cleft lip nasal symmetry after primary rhinoplasty is lacking. Twenty-nine nonsyndromic patients with complete unilateral cleft lip and palate undergoing modified rotation advancement cheiloplasty with synchronous primary rhinoplasty in our center were prospectively recruited in our study. All of them received our center's peri-operative management protocol, including presurgical naso-alveolar molding and postoperative nasal stenting. Direct anthropometric measurements of their nasal configuration were documented when they were anesthetized for primary lip repair at 3 months of age and for the primary palate repair at 12 months of age. Their nasal configurations were analyzed before primary rhinoplasty and at 9 months after rhinoplasty. There is a statistically significant change in nasal symmetry at 9 months after the primary rhinoplasty. There is no significant correlation between the nasal configuration before and at 9 months after the primary rhinoplasty. With significant relapse of nasal deformity at 9 months after the primary rhinoplasty despite the use of presurgical naso-alveolar molding and postoperative nasal stenting, overcorrection of the nasal configuration at primary rhinoplasty should be considered for optimal long-term nasal symmetrical outcome.

Modified Activation Technique for Nasal Stent of Nasoalveolar Molding Appliance for Columellar Lengthening in Bilateral Cleft Lip/Palate.

Bilateral cleft lip/cleft palate is associated with nasal deformities typified by a short columella. The presurgical nasoalveolar molding (NAM) therapy approach includes reduction of the size of the intraoral alveolar cleft as well as positioning of the surrounding deformed soft tissues and cartilages. In a bilateral cleft patient, NAM, along with columellar elongation, eliminates the need for columellar lengthening surgery. Thus the frequent surgical intervention to achieve the desired esthetic results can be avoided. This article proposes a modified activation technique of the nasal stent for a NAM appliance for columellar lengthening in bilateral cleft lip/palate patients. The design highlights relining of the columellar portion of the nasal stent and the wire-bending of the nasal stent to achieve desirable results within the limited span of plasticity of the nasal cartilages. With this technique the vertical taping of the premaxilla to the oral plate can be avoided.

Implantable Devices/Drugs in the Management of Nasal Polyps.

The use of biomaterials, which include nasal packing and sinus stents, has an evolving role in the postoperative management of patients with chronic rhinosinusitis with polyps. Some of these biomaterials include drug-eluting properties. The usage of biomaterials postoperatively is both surgeon and patient specific. The published literature supports the use of these products and demonstrates the ability to limit swelling, lateralization and reduce polyp regrowth postoperatively. However, there are heterogeneity in both available materials and results that the otolaryngologist must factor in to the decision-making algorithm.

MgNd2 alloy in contact with nasal mucosa: an in vivo and in vitro approach.

Biodegradable and biocompatible magnesium alloys appear to be very promising not only for temporary clinical application but also for developing deformable and degradable medical implants. This study analyzes the in vivo degradation behavior and the impact on the paranasal sinuses of the highly ductile Mg-2wt%Nd alloy (MgNd2) in order to provide a basis for a satisfying stent system for the therapy of a chronic sinusitis. Moreover, in vitro tests were carried out on primary porcine nasal epithelial cells (PNEC). For the in vivo tests, cylindrical MgNd2 specimens were implanted into the sinus' mucosa of minipigs. During and after a total period of 180days the long-term biodegradation and biocompatibility properties after direct contact with the physiological tissue were analyzed. Biodegradation was investigated by measuring the mass and volume losses of the MgNd2 specimens as well as by performing element analyses to obtain information about the degradation layer. The influence on the surrounding tissue of paranasal sinuses was evaluated by endoscopic and histopathological examinations of the mucosa. Here, only a locally unspecific chronic infection was found. The degradation rate showed a maximum after 45days postsurgery and was determined to decrease subsequently. In vitro experiments using PNEC showed adequate biocompatibility of MgNd2. This study demonstrates a good in vivo biocompatibility for MgNd2 in the system of paranasal sinuses and underlines the promising properties of alloy MgNd2 for biodegradable nasal stent applications.

Rhinoplasty in Clefts: An 18-Year Retrospective Review.

Cleft rhinoplasty has spurred much interest in literature because of the difficult task in obtaining a normal nasal form, function, and development. The pursuit of perfection has resulted in myriad techniques, modifications, and innovations to optimize results, but no one protocol or algorithm was proved to be completely satisfactory. Controversies still exist in timing, surgical approach, nonsurgical techniques, and outcome assessment. This article submits a humble contribution that might hopefully help in reaching consensus. Throughout a period of 18 years, 800 patients with different ages and types of clefts were managed by single surgeon using various procedures to correct their nasal deformities. These procedures included preoperative naso-alveolar molding, gingivoperiosteoplasty, primary closed or open rhinoplasty, postoperative nasal stents and nasal molding, and secondary open septorhinoplasty. The outcome was judged by panel assessment and computer-assisted anthropometry. Clinical results were satisfactory for most patients, parents, and surgeon panel. Computer-assisted anthropometry proved helpful in outcome assessment and analysis. Cleft rhinoplasty is neither optional nor separable from cleft lip repair. It requires clear perception of the complex pathogenesis and the governing dynamics of the cleft deformity. A perfect nose with no deformity is unusual, but a reasonably good result is attainable when the principles of nasal repair are fully grasped and faithfully applied.