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

Incipian, Llc, Laguna Niguel CA

Investigators

Abstract

? DESCRIPTION (provided by applicant): Tracheal stenosis is a life-threatening, fixed, extrathoracic restriction in pulmonary ventilation. Approximately 90% of all cases in adults and children results from endotracheal intubation with reported incidence of tracheal stenosis following intubation ranging in 6-21%. 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 2.4% 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 1). 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 2). Finally, validity of tracheal EMR will be tested in-vivo in rabbit model (Aim 3). 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.