In the United States alone, over 2.5 million diagnostic catheterization procedures are performed annually. These procedures are not performed without risk, and a number of complications such as hematoma, pseudoaneurysm, and arteriovenous fistula occur that are responsible for considerable morbidity and some mortality. In addition, many of these complications result in considerable increases in hospital stays and their associated costs. A number of commercial devices to seal catheter wounds have been developed and are being marketed; however, these devices have drawbacks-they lack effectiveness, are too expensive, or are diffcult to use. In our preliminary studies, we demonstrated that High Intensity Focused Ultrasound (HITU) can be successfully used to induce hemostasis of catheter wounds in large laboratory animals. Because ultrasound can be applied transcutaneously, the use of HITU for catheter wound closing has considerable promise. In this Phase I application, we propose to (1) develop a device that would use ultrasound imaging and HITU to produce noninvasive catheter wound sealing, (2) test this device on laboratory animals, and (3) investigate any collateral bioeffects of this procedure. The Phase II study would utilize these results to build a model for human use. In Phase III, human clinical trals would be performed.
More than 7,000,000 percutaneous catheterization procedures are performed each year, each leaving behind an arterial puncture that must be sealed. The envisioned product would facilitate a rapid, noninvasive means for accomplishing this task. If successful, the product would become a standard of practice because it speeds sealing, increases catheterization laboratory throughput, reduces overnight hospitalizations, and does not require interruption of the patients anticoagulation therapy.
