Background With increasing research on system integration for image-guided therapy (IGT), there has been a strong demand for standardized communication among devices and software to share data such as target positions, images and device status. Method We propose a new, open, simple and extensible network communication protocol for IGT, named OpenIGTLink, to transfer transform, image and status messages. We conducted performance tests and use-case evaluations in five clinical and engineering scenarios. Results The protocol was able to transfer position data with submillisecond latency up to 1024 fps and images with latency of <10 ms at 32 fps. The use-case tests demonstrated that the protocol is feasible for integrating devices and software. Conclusion The protocol proved capable of handling data required in the IGT setting with sufficient time resolution and latency. The protocol not only improves the interoperability of devices and software but also promotes transitions of research prototypes to clinical applications..
This paper presents an overview of the image-guided surgery toolkit (IGSTK). IGSTK is an open source C++ software library that provides the basic components needed to develop image-guided surgery applications. It is intended for fast prototyping and development of image-guided surgery applications. The toolkit was developed through a collaboration between academic and industry partners. Because IGSTK was designed for safety-critical applications, the development team has adopted lightweight software processes that emphasizes safety and robustness while, at the same time, supporting geographically separated developers. A software process that is philosophically similar to agile software methods was adopted emphasizing iterative, incremental, and test-driven development principles. The guiding principle in the architecture design of IGSTK is patient safety. The IGSTK team implemented a component-based architecture and used state machine software design methodologies to improve the reliability and safety of the components. Every IGSTK component has a well-defined set of features that are governed by state machines. The state machine ensures that the component is always in a valid state and that all state transitions are valid and meaningful. Realizing that the continued success and viability of an open source toolkit depends on a strong user community, the IGSTK team is following several key strategies to build an active user community. These include maintaining a users and developers’ mailing list, providing documentation (application programming interface reference document and book), presenting demonstration applications, and delivering tutorial sessions at relevant scientific conferences.
The introduction of software technology in a life-dependent environment requires the development team to execute a process that ensures a high level of software reliability and correctness. Despite their popularity, agile methods are generally assumed to be inappropriate as a process family in these environments due to their lack of emphasis on documentation, traceability, and other formal techniques. Agile methods, notably Scrum, favor empirical process control, or small constant adjustments in a tight feedback loop. This paper challenges the assumption that agile methods are inappropriate for safety-critical software development. Agile methods are flexible enough to encourage the right amount of ceremony; therefore if safety-critical systems require greater emphasis on activities like formal specification and requirements management, then an agile process will include these as necessary activities. Furthermore, agile methods focus more on continuous process management and code-level quality than classic software engineering process models. We present our experiences on the image-guided surgical toolkit (IGSTK) project as a backdrop. IGSTK is an open source software project employing agile practices since 2004. We started with the assumption that a lighter process is better, focused on evolving code, and only adding process elements as the need arose. IGSTK has been adopted by teaching hospitals and research labs, and used for clinical trials. Agile methods have matured since the academic community suggested they are not suitable for safety-critical systems almost a decade ago, we present our experiences as a case study for renewing the discussion.
We present three image-guided navigation systems developed for needle-based interventional radiology procedures, using the open source image-guided surgery toolkit (IGSTK). The clinical procedures we address are vertebroplasty, RF ablation of large lung tumors, and lung biopsy. In vertebroplasty, our system replaces the use of fluoroscopy, reducing radiation exposure to patient and physician. We evaluate this system using a custom phantom and compare the results obtained by a medical student, an interventional radiology fellow, and an attending physician. In RF ablation of large lung tumors, our system provides an automated interventional plan that minimizes damage to healthy tissue and avoids critical structures, in addition to accurate guidance of multiple electrode insertions. We evaluate the system's performance using an animal model. Finally, in the lung biopsy procedure, our system replaces the use of computed tomographic (CT) fluoroscopy, reducing radiation exposure to patient and physician, while at the same time enabling oblique trajectories which are considered challenging under CT fluoroscopy. This system is currently being used in an ongoing clinical trial at Georgetown University Hospital and was used in three cases.
Purpose-The purpose of the study was to develop an image guidance system that incorporates volumetric planning of spherical ablations and electromagnetic tracking of radiofrequency electrodes during insertion.Methods-Simulated tumors were created in 3 live swine by percutaneously injecting agar nodules into the lung. A treatment plan was devised for each tumor using our optimization software to solve the planning problem. The desired output was the minimum number of overlapping ablation spheres necessary to ablate each tumor and the margin. The insertion plan was executed using the electromagnetic tracking system that guided the insertion of the probe into pre-computed locations. After a 72 hour survival, histopathologic sections of the tissue were examined for cell viability and burn pattern analysis.Results-A planning algorithm to spherically cover the tumors and the margin was computed. Electromagnetic tracking allowed successful insertion of the instrument and impedance roll-off was reached in all ablations. Depending on their size, the tumors and the tumor margins were successfully covered with 2 to 4 ablation spheres. The image registration error was 1.0 ± 0.64mm. The overall error of probe insertion was 9.4 ± 3.0mm (n=8). Histopathologic sections confirmed successful ablations of the tissue.Conclusions-Computer assisted RF ablation planning and electromagnetically tracked probe insertion were successful in 3 swine, thus validating the feasibility of electromagnetic tracking assisted tumor targeting. Image mis-registration due to respiratory motion and tissue deformation contributed to the overall error of probe insertion.
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