Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh.

Parenteral routes of drug administration are often selected to optimize actual dose of drug delivered, assure high bioavailability, bypass first-pass metabolism or harsh gastrointestinal environments, as well as maximize the speed of onset. Intramuscular (IM) delivery can be preferred to intravenous delivery when initiating intravenous access is difficult or impossible. Drugs can be injected intramuscularly using a syringe or an automated delivery device (autoinjector). Investigation into the IM delivery dynamics of these methods may guide further improvements in the performance of injection technologies. Two porcine model studies were conducted to compare differences in dispersion of injectate volume for different methods of IM drug administration. The first study compared the differences in the degree of dispersion and uptake of injectate following the use of a manual syringe and an autoinjector. The second study compared the spatial spread of the injected formulation, or dispersion volume, and uptake of injectate following the use of five different autoinjectors (EpiPen(®) [0.3 mL], EpiPen(®) Jr [0.3 mL], Twinject(®) [0.15 mL, 0.3 mL], and Anapen(®) 300 [0.3 mL]) with varying needle length, needle gauge, and force applied to the plunger. In the first study, the autoinjector provided higher peak volumes of injectate, indicating a greater degree of dispersion, compared with manual syringe delivery. In the second study, EpiPen autoinjectors resulted in larger dispersion volumes and higher initial dispersion ratios, which decreased rapidly over time, suggesting a greater rate of uptake of injectate than the other autoinjectors. The differences in dispersion and uptake of injectate are likely the result of different functional characteristics of the delivery systems. Both studies demonstrate that the functional characteristics of the method for delivering IM injections impact the dispersion and uptake of the material injected, which could significantly affect the pharmacokinetics and, ultimately, the effectiveness of the drug.

Needle-based interventions with the image-guided surgery toolkit (IGSTK): from phantoms to clinical trials.

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.

Electromagnetic tracking in the clinical environment.

When choosing an electromagnetic tracking system (EMTS) for image-guided procedures several factors must be taken into consideration. Among others these include the system's refresh rate, the number of sensors that need to be tracked, the size of the navigated region, the system interaction with the environment, whether the sensors can be embedded into the tools and provide the desired transformation data, and tracking accuracy and robustness. To date, the only factors that have been studied extensively are the accuracy and the susceptibility of EMTSs to distortions caused by ferromagnetic materials. In this paper the authors shift the focus from analysis of system accuracy and stability to the broader set of factors influencing the utility of EMTS in the clinical environment. The authors provide an analysis based on all of the factors specified above, as assessed in three clinical environments. They evaluate two commercial tracking systems, the Aurora system from Northern Digital Inc., and the 3D Guidance system with three different field generators from Ascension Technology Corp. The authors show that these systems are applicable to specific procedures and specific environments, but that currently, no single system configuration provides a comprehensive solution across procedures and environments.

Electromagnetic tracking-guided percutaneous intrahepatic portosystemic shunt creation in a swine model.

Electromagnetic tracking potentially may be used to guide percutaneous needle-based interventional procedures. This brief report describes our initial experience with an electromagnetic guidance system featuring real-time tracking of respiratory-related target motion using an internal fiducial. An algorithm based on a "freehand" needle puncture technique was employed to puncture the right portal vein and a right hepatic vein for percutaneous intrahepatic portosystemic shunt in a swine model. Preoperative computed tomographic images registered with the electromagnetically tracked needle position were displayed for guidance. Successful puncture was confirmed angiographically. Simultaneous percutaneous transhepatic puncture of the targeted veins was accomplished on the initial attempt.

Implementation of an electromagnetic tracking system for accurate intrahepatic puncture needle guidance: accuracy results in an in vitro model.

RATIONALE AND OBJECTIVES: Electromagnetic tracking potentially may be used to guide percutaneous needle-based interventional procedures. The accuracy of electromagnetic guided-needle puncture procedures has not been specifically characterized. This article reports the functional accuracy of a needle guidance system featuring real-time tracking of respiratory-related target motion. MATERIALS AND METHODS: A needle puncture algorithm based on a "free-hand" needle puncture technique for percutaneous intrahepatic portocaval systemic shunt was employed. Preoperatively obtained computed tomographic images were displayed on a graphical user interface and registered with the electromagnetically tracked needle position. The system and procedure was tested on an abdominal torso phantom containing a liver model mounted on a motor-driven platform to simulate respiratory excursion. The liver model featured two hollow tubes to simulate intrahepatic vessels. Registration and respiratory motion tracking was performed using four skin fiducials and a needle fiducial within the liver. Success rates for 15 attempts at simultaneous puncture of the two "vessels" of different luminal diameters guided by the electromagnetic tracking system were recorded. RESULTS: Successful "vessel" puncture occurred in 0%, 33%, and 53% of attempts for 3-, 5-, and 7-mm diameter "vessels," respectively. Using a two-dimensional accuracy prediction analysis, predicted accuracy exceeded actual puncture accuracy by 25%-35% for all vessel diameters. Accuracy outcome improved when depth-only errors were omitted from the analysis. CONCLUSIONS: Actual puncture success rate approximates predicted rates for target vessels 5 mm in diameter or greater when depth errors are excluded. Greater accuracy for smaller diameter vessels would be desirable for implementation in a broader range of clinical applications.

Electromagnetic tracking for abdominal interventions in computer aided surgery.

Electromagnetic tracking has great potential for assisting physicians in precision placement of instruments during minimally invasive interventions in the abdomen, since electromagnetic tracking is not limited by the line-of-sight restrictions of optical tracking. A new generation of electromagnetic tracking has recently become available, with sensors small enough to be included in the tips of instruments. To fully exploit the potential of this technology, our research group has been developing a computer aided, image-guided system that uses electromagnetic tracking for visualization of the internal anatomy during abdominal interventions. As registration is a critical component in developing an accurate image-guided system, we present three registration techniques: 1) enhanced paired-point registration (time-stamp match registration and dynamic registration); 2) orientation-based registration; and 3) needle shape-based registration. Respiration compensation is another important issue, particularly in the abdomen, where respiratory motion can make precise targeting difficult. To address this problem, we propose reference tracking and affine transformation methods. Finally, we present our prototype navigation system, which integrates the registration, segmentation, path-planning and navigation functions to provide real-time image guidance in the clinical environment. The methods presented here have been tested with a respiratory phantom specially designed by our group and in swine animal studies under approved protocols. Based on these tests, we conclude that our system can provide quick and accurate localization of tracked instruments in abdominal interventions, and that it offers a user-friendly display for the physician.

Precision targeting of liver lesions using a novel electromagnetic navigation device in physiologic phantom and swine.

Radiofrequency ablation of primary and metastatic liver tumors is becoming a potential alternative to surgical resection. We propose a novel system that uses real-time electromagnetic position sensing of the needle tip to help with precision guidance into a liver tumor. The purpose of this study was to evaluate this technology in phantom and animal models. Using an electromagnetic navigation device, instrumented 18 g needles were advanced into radioopaque tumor targets in a respiratory liver phantom. The phantom featured a moving liver target that simulated cranio-caudal liver motion due to respiration. Skin-to-target path planning and real-time needle guidance were provided by a custom-designed software interface based on pre-operative 1 mm CT data slices. Needle probes were advanced using only the electromagnetic navigation device and software display. No conventional real-time imaging was used to assist in advancing the needle to the target. Two experienced operators (interventional radiologists) and two inexperienced ones (residents) used the system. The same protocol was then also used in two anesthetized 45 kg Yorkshire swine where radioopaque agar nodules were injected into the liver to serve as targets. A total of 76 tumor targeting attempts were performed in the liver phantom, and 32 attempts were done in the swine. The average time for path planning was 30 s in the phantom, and 63 s in the swine. The median time for the actual needle puncture to reach the desired target was 33 s in the phantom, and 42 s in the swine. The average registration error between the CT coordinate system and electromagnetic coordinate system was 1.4 mm (SD 0.3 mm) in the phantom, and 1.9 mm (SD 0.4 mm) in the swine. The median distance from the final needle tip position to the center of the tumor was 6.4 mm (SD 3.3 mm, n=76) in the phantom, and 8.3 mm (SD 3.7 mm, n=32) in the swine. There was no statistical difference in the planning time, procedure time, or accuracy of needle placement between experienced and inexperienced operators. The novel electromagnetic navigation system allows probe delivery into hepatic tumors of a physiologic phantom and live anesthetized swine. The system allows less experienced operators to perform equally well as experienced radiologists in terms of procedure time and accuracy of needle probe delivery.

Navigation with electromagnetic tracking for interventional radiology procedures: a feasibility study.

PURPOSE: To assess the feasibility of the use of preprocedural imaging for guide wire, catheter, and needle navigation with electromagnetic tracking in phantom and animal models. MATERIALS AND METHODS: An image-guided intervention software system was developed based on open-source software components. Catheters, needles, and guide wires were constructed with small position and orientation sensors in the tips. A tetrahedral-shaped weak electromagnetic field generator was placed in proximity to an abdominal vascular phantom or three pigs on the angiography table. Preprocedural computed tomographic (CT) images of the phantom or pig were loaded into custom-developed tracking, registration, navigation, and rendering software. Devices were manipulated within the phantom or pig with guidance from the previously acquired CT scan and simultaneous real-time angiography. Navigation within positron emission tomography (PET) and magnetic resonance (MR) volumetric datasets was also performed. External and endovascular fiducials were used for registration in the phantom, and registration error and tracking error were estimated. RESULTS: The CT scan position of the devices within phantoms and pigs was accurately determined during angiography and biopsy procedures, with manageable error for some applications. Preprocedural CT depicted the anatomy in the region of the devices with real-time position updating and minimal registration error and tracking error (<5 mm). PET can also be used with this system to guide percutaneous biopsies to the most metabolically active region of a tumor. CONCLUSIONS: Previously acquired CT, MR, or PET data can be accurately codisplayed during procedures with reconstructed imaging based on the position and orientation of catheters, guide wires, or needles. Multimodality interventions are feasible by allowing the real-time updated display of previously acquired functional or morphologic imaging during angiography, biopsy, and ablation.

Safe teleradiology: information assurance as project planning methodology.

The Georgetown University Medical Center Department of Radiology used a tailored version of OCTAVE, a self-directed information security risk assessment method, to design a teleradiology system that complied with the regulation implementing the security provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The system addressed threats to and vulnerabilities in the privacy and security of protected health information. By using OCTAVE, Georgetown identified the teleradiology program's critical assets, described threats to the assurance of those assets, developed and ran vulnerability scans of a system pilot, evaluated the consequences of security breaches, and developed a risk management plan to mitigate threats to program assets, thereby implementing good information assurance practices. This case study illustrates the basic point that prospective, comprehensive planning to protect the privacy and security of an information system strategically benefits program management as well as system security.

Modeling and simulation role in designing a Teleradiology system.

In designing complex systems, Engineers, Developers and Systems Architects always have to make quantitative assumptions in order to satisfy anticipated loads and expectations of the final product. Many questions are asked before any complex system design that relate to systems performance, infrastructure and components configuration, behavior prediction and bottlenecks fixes. All these questions can be answered using modeling and simulation tools that allow engineers to predict systems behaviors in different settings and optimize systems in production by identifying bottlenecks and flaws in the infrastructure or workflow.

Robotically assisted nerve and facet blocks: a cadaveric study.

RATIONALE AND OBJECTIVES: This study was performed to evaluate the feasibility of using a joystick-controlled robotic needle driver to place a 22-gauge needle for nerve and facet blocks. MATERIALS AND METHODS: Biplane fluoroscopy and a robotic needle driver were used to place 12 needles into the lumbar paraspinal region of an embalmed female cadaver (age at death, 98 years). Small metal BB nipple markers (1 mm in diameter) were inserted percutaneously to serve as targets. Six needles were then placed near the nerve root, and six were placed near the facet root. Anteroposterior and lateral radiographs were obtained after each needle placement to assess its accuracy. RESULTS: All needles were placed within 3 mm of the target BB. The average distance was 1.44 mm +/- 0.66 (standard deviation). DISCUSSION: A robotic needle driver can be used to place needles accurately in the nerve and facet regions. Clinical studies are required to investigate the advantages and disadvantages of this system for interventional procedures involving needles.