Figure 1. The Spiration Valve

The Device Description

The Spiration Valve System consists of three main parts.

 

The Valve

The umbrella shaped valve is made of a flexible metal frame (nitinol – composed of titanium and nickel) covered by a thin sheet of flexible plastic, a polymer membrane (see Figure 1). The valve is designed to fit the shape and size of airways of the lung. The valve is a one-way device, which means that the plastic umbrella blocks air from moving further into your lungs toward the air leak, but allows trapped air to move out of your lungs as you breath out (see Figures 2 a and b). Blocking air from reaching the air leak is what may help the air leak heal. The valve has five flexible anchors that settle into the airway wall helping the valve stay in place. The valves are available in a few different sizes to fit various airways. The valve is designed to be removed once the air leak has healed.

Figure 2 a and b. Illustration of the Spiration Valve blocking new air while allowing trapped air and fluids to escape.

 

The Deployment Catheter and Loader

The loader (see Figure 3 a) is used during the procedure to load the valve into a narrow tube called the deployment catheter. The deployment catheter (see Figure 3 b) delivers the valve to your airway. The parts of this catheter that touch the patient are made of stainless steel, plastic, nylon, and non-toxic yellow dye.

Figure 3 a and b. The Loader and Deployment Catheter

 

The Airway Sizing Kit

The airway sizing kit is used to prepare a narrow, flexible tube with a small balloon at the end (balloon catheter) for use during the procedure. None of the contents of this kit are used as part of the valve placement procedure.

 

Other Required Items

There are a few things required for the procedure that are not included in the Spiration Valve System. These include a balloon catheter and a bronchoscope.

The Balloon Catheter

The balloon catheter is a narrow, flexible tube with a small balloon at the end. It is used to find the air leak and to measure airways inside of your lungs (see Figure 4).

Figure 4. A Balloon Catheter

Bronchoscope

A bronchoscope is a narrow, flexible tube that goes into your lungs. There is a camera on the end so that doctors can see internal organs. In this procedure the camera will allow your doctor to see the airways of your lung. The deployment catheter and balloon catheter go through the bronchoscope to reach the airways (see Figure 5).

Figure 5. Bronchoscope with a Spiration Valve Catheter