The US Air Force seeks a partner to license and commercialize a novel medical device for the the precise location of catheters and similar interventional devices.
The placement of catheters, peripherally inserted central catheter (PICC) lines, central venous catheters (CVC) and other hardware in the body is difficult and prone to error. One study indicated that CVC of subclavian or internal jugular veins failed in upwards of 19% of patients depending on the health care professional’s experience. Major complications stemming from misplacement included pneumothorax, artery puncture, hematoma and neural injury.
Systems have been developed to assist in placing these devices including approaches based on X-ray, RF emission, magnetic resonance (MRI), and ultrasound. However, each of these approaches suffer from inherent problems such as subjecting the patient to ionizing radiation, RF energy which disrupts other electrophysical signals, significant thermal energy, or weak localization signal.
The device developed by the Air Force solves or substantially reduces the above problems by illuminating the catheter in order to visualize the end-point location and orientation, and to track the movement of the catheterization device within passageways in the body. The invention substantially allows the insertion and tracking of any catheterization type device for any procedure requiring vascular access, such as in the placement of a PICC line, heart catheterization, angioplasty, urinary track catheterization, or other bodily access procedures.
The device incorporates light emitting diodes (LEDs) projecting outwards from the catheter or device. LED’s can have multitude wavelengths from the visible to the near infrared which can be detected from outside the body with low-level light detectors such as an image intensifier tube, night vision goggle, charge coupled device, a metal-on-silicon controlled imaging detector, and within certain limits, visible real-time imaging with the unaided eye.
- Absolute determination of location of catheter tip
- No radiation (as opposed to X-ray and X-ray fluoroscopy procedures)
- No heating of the target area common to RF based localization
- Can be used in combination with orthoscopic surgery resulting in reduction of X-ray exposure
- light permits visualization of the vasculature passages for branches or other obstructions, such as plaque, and arterial-venous shunts
- US Patent number 7,917,193 available for licensing