SBIR-STTR Award

The overall objective of the proposed cooperative research and development project is the implementation and validation of an advanced instrument tracking technology to be used by the surgeon, the radiologist, the gastroenterologist, and other physicians to better enable image-guided cancer treatment, through these specific aims: Specific aim 1: Ascension Technology Corporation (ATC) has developed a fast and accurate DC magnetic position and orientation tracking device of 1-4 sensors with minimal occlusion, drift or distortion from conductive materials. A key feature is that the device may be implemented in a flat-plate transmitter configuration, which rests on the patient's bed and is unobtrusive while overcoming metal distortion effects. The device provides full six degrees-of-freedom tracking and connects to a host computer via a PCI bus. The deliverable of this specific aim will be a fully functioning tracking device in this flat transmitter configuration, suitable for non-human test and evaluation. Specific aim 2: MGH investigators will design applications in phantom and animal model systems to serve as the testbed for the novel tracking device. We will integrate the tracking device into a) a laparoscopic ultrasound system, and b) instruments used in ablative techniques (e.g. radio frequency ablation). Specific aim 3: A series of bench and animal experiments will be performed by the full team to assess the accuracy and behavior of the device in real operating room conditions. These experiments will establish the technical merit of the tracking device and the feasibility of the proposed medical applications. Specific aim 4: The system will be evaluated in light of Aim 3 results to determine changes required to meet feasibility goals and preparation for Phase II. Phase II will include a) performance of human studies using the laparoscopic ultrasound application, and b) preliminary evaluation of the tracking device in other promising applications, such as the novel "gastric access" and the colonoscopic applications.

Thesaurus Terms:
biomedical equipment development, biosensor, diagnosis quality /standard, image guided surgery /therapy, neoplasm /cancer diagnosis, neoplasm /cancer therapy clinical biomedical equipment, early diagnosis, endoscopy, gastrointestinal disorder diagnosis, gastrointestinal imaging /visualization, gastrointestinal neoplasm, laparoscopy, miniature biomedical equipment, neoplasm /cancer radiodiagnosis, patient monitoring device biotechnology, phantom model, swine

This program will demonstrate the potential for commercial success of a novel approach for tracking and displaying the position and orientation of instruments in image-guided cancer interventions. Prototype systems will be demonstrated in selected pancreatic procedures in human subjects. New clinical applications will be examined and commercialization will begin for an accurate and cost-effective system to be used by physicians who intervene to cure cancer. An instrument tracking system with a novel flat-plate transmitter suitable for human test and evaluation will be implemented and demonstrated. The real time position of surgical instruments and supporting devices will be displayed in the context of volumetric images of the individual patient. This system will be evaluated for its potential to improve the surgical resection of pancreatic tumors in human patients. The tracking system will be used to display real time information in open and laparoscopic procedures, and its potential benefits gauged by the surgeon and trained observers through analysis after the completion of each case. Iterative improvements will be made to the system as experience is gained in human subject procedures. The system will also be evaluated for its potential to improve the guidance and ease of use of gastroscopic ultrasound- guided biopsies of the pancreas including tests in human subjects. Techniques for guiding access to the abdomen through the stomach wall will be developed and other novel approaches with great potential in image-guided interventions to remove cancer tumors will be explored. The tracking device will be integrated into the instruments used in trans-anal and possibly trans-vaginal procedures. The utility tracking platform to guide regional and local cancer treatment, local drug delivery, and the placement of markers to guide subsequent radiation therapy will also be investigated. A product and commercialization plan will be developed. This plan will be based on an extension and expansion of the current product and business strategy of Ascension Technology Corporation in conjunction with laparoscopic ultrasound manufacturer, B-K Medical. Among other elements, it will include production engineering, market and competitive analysis, the protection of intellectual property, and the development of a product release plan.

Public Health Relevance:
Many cancers in the abdomen are best treated by surgical removal. The novel image guidance system being developed and demonstrated in this program has the potential to improve the precision and speed of today's minimally invasive techniques, while simultaneously reducing trauma to the patient. The technique may also improve the quality of invasive diagnostic tests and the staging of cancer treatment.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.