The Department of Veterans Affairs has invented a novel medical device known as the steri-tip catheter, which is available for commercial development. Companies can license the patent rights to make, use, or sell the device in the marketplace.
Pneumonia is a leading cause of death in the U.S. and the single largest cause of death in children worldwide. Hospital-acquired pneumonia (HAP) is estimated to occur at a rate between five and 15 cases per 1,000 hospital admissions and carries a 30-70 percent mortality rate. HAP increases hospital stays by an average of seven to nine days per patient and has an associated cost of more than $40,000 per patient.
A key to addressing pneumonia is accurate diagnosis and there is debate around the most appropriate technique as clinical criteria alone is inadequate and obtaining samples is problematic. Culturing of endotracheal aspirates has been shown to yield false positive and false negatives exceeding 17 percent. This leads to an inappropriate treatment regimen, increased drug resistance, and poor outcomes.
The problems with cultures begin with how they are sampled. Catheters used in bronchoalveolar lavage to access the lung to obtain samples can become contaminated during insertion or during removal. It is also difficult to guide the catheter deep into the lower respiratory tract where pneumonia occurs.
As an alternative to existing tools, VA researchers have improved their steri-tip catheter. The steri-tip catheter was FDA approved and marketed with the advantage of avoiding inner lumen contamination during collection of respiratory tract specimens of intubated and non-intubated patients. This single or double lumen-protected catheter has a thin polyethylene glycol diaphragm applied at the distal end of the catheter to prevent entrance of contaminants into the system. When the catheter reaches the desired sampling area of the lung, the biodegradable diaphragm is easily ejected to provide an uncontaminated lumen to sample lower airway secretions. While this device represents a step forward in lung sampling, the device is difficult to guide.
VA researchers have made the following improvements to the device:
- Control mechanism for angulation of the flexible tip: Incorporation of one or two angulation wires to turn the distal flexible tip of the catheter. The angulation wires are attached to a separate control.
- Imaging assembly: Incorporation of a minute camera to allow visualization of the airways during placement. The camera is connected to a monitor by fiberoptics within the catheter. For larger internal lumen catheters, a telescoped-type catheter can be used.
While this improved Steri-Tip catheter is designed to retrieve lower respiratory tract secretions, it could be modified to be used in any surgical procedure where catheters are used to provide local fluid communication to a particular site or to obtain biological samples.
- Allows for collection of large amounts of lower respiratory tract secretions while avoiding sample contamination, leading to higher specificity and sensitivity
- Can be advanced in the airway by different routes including: flexible laryngoscope, flexible bronchoscope, endotracheal tube, or tracheostomy tube, expanding the availability of personnel capable of performing the procedure and making it available to more patients in a variety of clinical settings
- Early diagnosis and targeted antibiotic treatment
- Companies can make, use, or sell the invention by licensing international patent application 62/616,117 from the VA
- License fees paid to the VA are negotiable
- TechLink navigates businesses through licensing at no charge
- Companies that license the technology may further collaborate with the inventors