SBIR-STTR Award

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. PROPOSED COMMERCIAL APPLICATION: 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.

Despite dramatic advances in the battle against cardiovascular disease, sealing of the femoral arteriotomy following percutaneous, transcatheter procedures remains a major challenge In the United States alone, over 48 million of these procedures are performed annually Manual compression is the most widely used method for achieving arteriotomy hemostasis However, compression is very time consuming and requires significant hospital resources Moreover, patients report that the most painful aspects of their catheterization experience are the manual compression of their catheterization site and having to lie immobile for hours so as not to disrupt healing of their arteriotomy A number of commercial devices to seal catheter wounds have been developed and are being marketed, however, these devices have drawbacks--they are invasive, expensive, difficult to use and leave behind foreign material In our Phase I effort, we demonstrated that high intensity focused ultrasound (HIFU) can successfully be used to noninvasively seal arteriotomies in large laboratory animals and, subsequently, in humans subjects In this Phase II application, we propose to (1) develop a clinical-level prototype device that uses ultrasound imaging and HIFU to facilitate noninvasive femoral arteriotomy sealing, (2) conduct key preclinical studies in an animal model, and (3) design and develop a phase I clinical trial protocol In Phase III, human clinical trials would be performed and product commercialization would commence.

Thesaurus Terms:
biomedical equipment development, diagnostic catheterization, surgery material /equipment, ultrasound imaging /scanning, ultrasound therapy, wound, wound healing hemostasis, ultrasound biological effect bioimaging /biomedical imaging, sheep