Researchers in Toulouse have successfully developed and implanted several customized, 3D printed stents that are anatomically identical to patients’ trachea and/or bronchi, offering hope to patients for whom standard prostheses are not a viable solution. This has been achieved through a collaboration between the Pulmonology Department at Toulouse University Hospital and Toulouse-based start-up company, AnatomikModeling.
The first results from a clinical trial in which these new generation stents have been implanted have just been published in the most prestigious international pneumology journal, the American Journal of Respiratory and Critical Care Medicine3.
Indications for the implantation of a tracheobronchial prosthesis
Narrowing (or stenosis) of the trachea and/or bronchi leads to breathing difficulties and requires specific management through the implantation of a stent. Stenosis can occur due to a variety of reasons, such as post-intubation and post-tracheotomy problems, post-lung transplantation complications, , diseases of the tracheal tissue and anatomical idiosyncrasies of the trachea. Obstruction of these upper airways is also a common complication in lung cancer patients.
The limits of standard prostheses
Currently, the standard prostheses used are suitable for most patients. However, they are not appropriate for some patients in terms of size, diameter, etc, or in cases with complex tracheal or bronchial anatomy. Poorly adapted prostheses present a risk of stent migration, inflammatory reaction and/or perforation. Thus, there is a great need for innovation in this field in order to overcome these issues.
A remarkable innovation: initial clinical trial results promising
These new prostheses are custom-made in three steps: first, a 3D reconstruction of the patient’s airways is produced from CT-scan images. This virtual reconstruction is then used to create a mould. Finally, a patient-specific prosthesis is manufactured from medical grade silicone elastomer.
The prosthesis is implanted by conventional bronchoscopy with the help of a prosthesis pusher, in the operating room under general anesthesia. In addition, the rigidity of the stent can be calculated as a function of the stenosis.
This new technology is being evaluated in an ongoing clinical trial. Through this, several patients have successfully received these implants, resulting in markedly improved quality of life with no complications so far.