Manual control of the upper esophageal sphincter.

OBJECTIVES/HYPOTHESIS: Oropharyngeal dysphagia (OPD) is common and costly. In order to improve quality of life for patients and costs to society, better treatments than currently available are needed. The author hypothesized that manual control of the upper esophageal sphincter (UES) is possible by pulling the larynx directly forward with anterior traction on the cricoid cartilage. The purpose of this investigation was to evaluate the effectiveness of manual control of the UES as a possible therapy for OPD. STUDY DESIGN: Retrospective chart review, medical device development, prospective cadaver trial, and prospective animal experiment. METHODS: Charts were reviewed of all persons with OPD who had a traction suture placed by the author around the anterior rim of the cricoid cartilage. The opening of the UES was assessed with and without traction on the suture. The ability of the cricoid suture to improve UES opening was evaluated under fluoroscopy. The Swallow Expansion Device (SED) was designed to manually control the UES. The ability of the SED to manually open the UES was evaluated. The SED was implanted in 10 cadavers, and 5,000 pulls of the device were performed on each specimen to evaluate for gross damage to the cricoid cartilage. The ability of the SED to open the UES was evaluated under direct laryngoscopy. The safety and efficacy of the SED was evaluated in an ovine model of OPD. The SED was implanted in eight sheep. Five thousand pulls of the device were performed on each animal weekly for 8 weeks. At the end of the study, damage to the cricoid cartilage was evaluated histologically, and the ability of the SED to open the UES and eliminate aspiration was assessed fluoroscopically. RESULTS: Six patients with OPD who had a suture placed around the anterior aspect of the cricoid cartilage were identified. Anterior traction on the suture improved UES opening by 0.36 cm (+/-0.19 cm) (P < .01). A titanium-coated ferrous implant that secures to the cricoid cartilage was fabricated (SED). An external magnetic device that affixes to the implant across intact skin was developed. Anterior traction of the SED opened the UES in cadavers a mean of 1.16 cm (+/-0.22 cm) (P < .001). Anterior traction on the SED opened the UES in sheep a mean of 1.27 cm (+/-0.36) (P < .001). Aspiration was eliminated in 100% of the animals. The implant became infected and had to be removed in one (12.5%) animal. Remodeling of the cricoid cartilage was evident, but there was no histologic evidence of cartilage damage. CONCLUSIONS: Manual control of the upper esophageal sphincter is possible. Simple anterior traction on the suture placed around the cricoid cartilage improved UES opening by 0.36 cm (+/-0.19) in a cohort of dysphagic patients. The Swallow Expansion Device opened the UES of cadavers and living sheep to superphysiologic proportions (P < .001). There was no histologic evidence of cricoid damage from prolonged use of the implant.

Transcutaneous injection laryngoplasty through the cricothyroid space in the sitting position: anatomical information and technique.

A variety of approaches have been introduced to perform injection laryngoplasty under local anesthesia. Among these reported methods, transcutaneous injection through the cricothyroid space offers many advantages, but it possesses some technical difficulties during access to the vocal fold. The aim of this study was to assess the anatomic references related to transcutaneous injection laryngoplasty through cricothyroid space using 3-dimensionally reconstructed computed tomography to provide guidelines and to achieve higher efficacy during the procedure. The study group consisted of 14 patients (7 male, 7 female) with unilateral vocal fold paralysis and who had undergone multi-detector array computed tomography (MDCT) between January 2004 and December 2005. Assumption was made that transcutaneous injection is approached from the surface at lower margin of the thyroid cartilage and 7 mm lateral to the midline through the cricothyroid membrane and spot at the posterior 1/3 of true vocal cord is the target for injection laryngoplasty. From the surface of the injection point to the target, a line was drawn. Its length and the angle formed between it and the approach direction of needle was measured. Based on these measurements, 15 patients (8 male, 7 female) with unilateral vocal fold paralysis received 15 trials of transcutaneous injection laryngoplasty through the cricothyroid space. The average length from the surface of the injection point (7 mm lateral to the midline) to the posterior 1/3 of the true vocal cord (target of the injection) was 15.75 mm in men and 13.91 mm in women. The average of the angle in medial direction at the surface needed to reach the target of the injection was 10.57 degrees in men and 12.71 degrees in women, and in superior direction was 47.57 degrees in men and 47.43 degrees in women. Injection laryngoplasty performed under acquired reference measurements were successful in 14 trials (93.3%) out of 15 trials in 15 patients. We suggest that knowledge of the anatomic references regarding the transcutaneous injection laryngoplasty through cricothyroid space will provide guidelines for beginners and improve the understanding of the procedure, eventually leading to easier and more precise access to the vocal cord.