SBIR-STTR Award

Image-guidance is revolutionizing many medical procedures by providing anatomical information and instrument position during interventions which, in turn, allows for minimally invasive techniques and access to ordinarily inaccessible parts of body. In many difficult procedures that involve vital structures, like the resection of tumors at the skull base, image-guidance can be a necessity. In such cases, the accuracy of the image guidance is often limited by the accuracy of imaging (especially registration). A fully integrated intraoperative image-guidance system combines both the imaging and guidance hardware into a single functioning system that can acquire highly accurate imagery repeatedly within the operating room (OR) environment. Such imagery is well-registered with the true patient coordinates since registration steps are not specifically needed. Moreover, having an intraoperative imager allows one to monitor changes in anatomy throughout a procedure and to assess progress. Such integrated systems have a great advantage over nonintegrated systems where the imagery is collected prior to a procedure followed by registration (i.e.: no updates, more chances for misregistration). Integrated systems based on magnetic resonance imaging are highly attractive due to image quality and lack of ionizing radiation; however, such units place heavy constraints on the OR and are very costly. Units based on ultrasound are inexpensive, but produce relatively poor imagery and are not suitable for regions near bony structures. To date a highly compact, interactive, inexpensive, integrated imaging and guidance system based on x-ray computed tomography (CT) has not been developed. Such a unit would fill a "modality vacancy" in intraoperative imaging and guidance, would provide updatable images familiar to surgeons, and would be particularly suited to difficult procedures like skull base surgery. We propose not only to build such a system (leveraging off previous developments at Xoran Technologies, Inc. for reducing the size of the imager and the effective dosage) but to evaluate the device through clinical trials for the specific task of resection of brain tumors

Recent advances in x-ray detectors and microcomputers have enabled compact and affordable computed tomography (CT) imaging devices to be successful in dental and otolaryngology applications. This technology holds promise for neurosurgical applications. Specifically, intraoperative imaging updates would benefit minimally-invasive treatment of brain cancer by providing anatomic updates to the surgeon and localization data updates to surgical navigation for more accurate, safe and complete neoplasm removal. In this project, a compact intra-operative flat-panel CT imager integrated with a surgical navigation system will be developed. The product will use advanced imaging methods to produce low-artifact soft tissue images, even in the skull base and posterior fossa, which are typically challenging regions for x-ray imagers. The product will offer soft tissue image quality unprecedented for x-ray based surgical navigation. It will also be the most compact and OR-friendly image-guided neurosurgical navigation system available to date. Phase 1 work demonstrated the feasibility of using flat panel cone beam CT for low contrast imaging, as required for neurosurgical applications. In Phase 2, further efforts are proposed to advance soft-tissue imaging capability and to integrate the imager with surgical navigation tools. A prototype will be evaluated in a pilot study for the specific minimally-invasive neurosurgical task of transphenoidal endonasal pituitary tumor resection surgery. If successful, approximately $13 M in annual revenue and 15 additional jobs will be generated in the southeast Michigan life sciences corridor.

Public Health Relevance:
Minimally invasive surgical procedures have many benefits to public health including reducing the medical risks and costs associated with brain cancer surgery. However such procedures are often time consuming and technically difficult as the surgeon is unable to directly visualize the area of the operation. In this project an intraoperative surgical system is developed with onboard imaging capability in order to enable minimally invasive brain surgeries to be performed more safely and completely, by providing hi- resolution imaging of the brain while the surgeon operates through the patients nose.

Thesaurus Terms:
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