Development and Validation of EMR-Stent System for Treatments of Tracheal Stenosis

DESCRIPTION provided by applicant Tracheal stenosis is a life threatening fixed extrathoracic restriction in pulmonary ventilation Approximately of all cases in adults and children results from endotracheal intubation with reported incidence of tracheal stenosis following intubation ranging in Correction of the stenotic tracheal airway generally requires a complex sequence of operations that may involve stenting dilation laser resection of cartilage open operations with cartilage graft harvest and placement or segmental resection However each of these procedures can be technically challenging and may fail to adequately treat the stenosis or in as high as result in death Other nonsurgical techniques such as stenting and balloon dilatation have shown good short term outcomes but have not been effective in the long term Electromechanical reshaping of cartilage EMR is a promising minimally invasive electrochemical technology to directly expand tracheal cartilage and treat tracheal stenosis EMR combined with a short term stent placement promises to be an alternative to the conventional surgery as EMR can potentially be delivered transmurally directly to cartilaginous tissue to accelerate mechanical stress relaxation with only minimal injuries tissues adjacent to the needles EMR thus can permanently reshape the tissue and reduce stenting time and possibility of secondary stenosis Our hypothesis is that proposed combination of EMR and stenting treatment will significantly increase tracheal lumen while preserving tissue viability required to maintain airway physiological functions and thus will reduce the time required for the stent to remain in trachea In this proposed work we hope to develop test and validate a tracheal stent with EMR electrode delivery system to dilate stenotic airway By selectively applying electric energy to the cartilage component of the trachea it can achieve widening of lumen while sparing surrounding tissue from significant injury Aim Then using ex vivo rabbit trachea we will establish appropriate EMR dosage that can be applied in a treatment with only with limited tissue damage Aim Finally validity of tracheal EMR will be tested in vivo in rabbit model Aim Upon successful completion of this Phase I study and building upon collected design and dosimetry information we will pursue efficacy and safety study in in vivo rabbit model and a pilot human study in Phase II We will finalize design of the stent and electrode delivery system for in vivo rabbit studies develop a system for EMR of tracheal stenosis in humans and receive IDE for a pilot human study in Phase II along with continued modification of the system towards the FDA approval as the first commercially available device for EMR treatment of tracheal stenosis in USA PUBLIC HEALTH RELEVANCE Tracheal stenosis is a life threatening fixed extrathoracic restriction in pulmonary ventilation Approximately of all cases in adults and children results from endotracheal intubation with reported incidence of tracheal stenosis following intubation ranges from Tracheal stenosis in adult and pediatric populations is exceedingly difficult deformity to treat and correct using conventional surgical methods with the death rate following surgery as high as The proposed product based on a novel electro mechanical reshaping of cartilage will enable minimally invasive treatments that reduce recovery time and possibility of secondary stenosis