Figure 1. A bronchoscope is placed through the mouth down into the lungs.


Figure 2. The stent is smaller than a pencil's eraser.

Goal of the airway bypass procedure

This trial will evaluate the safety and effectiveness of a new treatment, called the airway bypass procedure, to improve pulmonary function and dyspnea (breathlessness) in patients with advanced widespread emphysema. During the procedure new passages are created through the walls of the natural airway passages which will connect the damaged inner lung tissue and the larger natural air passages. These new passages may provide a pathway for the trapped air in the inner lung to escape by "bypassing" the collapsing small airways. After each new passage is made, a small drug-eluting stent (a wire mesh similar to what is used to keep coronary arteries open in heart disease) is implanted and provides support to keep the passageway open over time. The goal of the treatment is to allow trapped air to escape the lungs and thereby relieve some of the symptoms of emphysema, such as shortness of breath.

Details of the airway bypass procedure

The airway bypass procedure has the following steps:

• You will be given anesthesia or a sedative to make you go to sleep.
• A bronchoscope (a long thin tube with a light and lens that is used to look at the airways) will be inserted through your mouth and into your lungs (Figure 1).
• A small listening device will be inserted through the bronchoscope to identify a place in the airway wall that is away from blood vessels. This is an important step because it will reduce the chance that bleeding will occur.
• A very small needle will be inserted through the bronchoscope and will create the new passageway in the airway wall for the trapped air to escape.
• Lastly, a small drug-eluting stent is inserted through the bronchoscope and placed in the new passageway to keep the passage from closing over time. The stent is made out of stainless steel mesh, is covered with drug-infused silicone and is smaller than the eraser on the end of a pencil (Figure 2).
• During the procedure up to six stents will be implanted in different places in your lungs.
  

The entire procedure usually takes about one to two hours. You will be hospitalized overnight for observation.