Optical Diagnostics Laboratory. The Tearney Laboratory is dedicated to the development and clinical translation of novel optical imaging technologies. The Tearney Lab is comprised of three optics and biomedical engineering research laboratories, wet laboratory space, a dedicated pathology laboratory, cell culture room, three device fabrication facilities, a machining facility for prototyping, and a data server closet. The three optics labs are equipped with optical tables, laboratory benches, optical and optomechanical components, and electronics and optical testing equipment. Researchers share common laboratory space, facilities and major equipment. The function and resource of each laboratory/facility within the Tearney Laboratory relevant to the proposal is summarized below:
1. OCT imaging laboratory: A 400 sq. ft. optics laboratory is dedicated to the development of OCT, µOCT, DµOCT, PS-OCT, and multimodality OCT imaging technologies. The laboratory is equipped with multiple dedicated cardiovascular, pulmonary, and gastrointestinal OCT systems and probes. The laboratory also contains spectroscopic instrumentation for fluorescence and reflectance measurements. Additional equipment includes power meters, oscilloscopes, optical spectrum analyzers, and an RF spectrum analyzer.
2. Optical probe fabrication facilities: This are two clean room laboratories dedicated to the prototyping and production of optical probes for human use. The facilities contain the necessary equipment for assembly of optical imaging catheters and probes, including a dedicated fusion splicer (AFL LZM-100), beam profilers, power meters, polyimide and acrylate jacket strippers, fiber cleavers, a fiber/glass-processing device (Vytran LDS-1250), polisher (Ultrac TEC Ultrapol), microscope inspection workstation, and diamond saw.
3. Micromachining facility: This facility is used for machining small device parts for the µOCT console and rotary junction. The facility includes an ultra-high speed 5-axis CNC mill (MDA Precision) and high-speed CNC lathe (MDA Precision). Both CNC instruments are capable of micron-level precision to produce complex, finely detailed miniature parts. The facility is also equipped with micro-lathe and milling machines, and four 3D printers.
4. Console development laboratory: This laboratory space is dedicated to the development of diagnostic imaging consoles. The laboratory is equipped with power meters, optical spectrum analyzers, oscilloscopes, RF spectrum analyzer, and an electronics work bench for circuit fabrication.
5. Pathology Laboratory: A BL-2 laboratory space dedicated to gross dissection of cadaver/surgical specimens prior to imaging studies and subsequent tissue processing for histology. The wet laboratory space includes a dissection bench, refrigerator, gross photography station and supplies.
65 Landsdowne
65 Landsdowne Device Fabrication Facility. The Device Fabrication Facility comprises 3000 sq. ft. of space dedicated to GMP manufacturing of clinical devices, including gastrointestinal imaging probes and intracoronary catheters. The facility includes an optical fabrication area, 3D optics printing clean room, a state-of-the-art machine shop, two class 10000 clean rooms, and incoming inventory and finished clinical storage rooms. The Device Fabrication Facility also has seating for approximately 30 engineers and technicians that comprise the Tearney Lab’s manufacturing team.
Regulatory. The Laboratory has a clinical and regulatory team, which is dedicated to preparing for approval of clinical and preclinical studies for significant and non-significant risk devices, and to manage all regulatory aspects of the studies. The team works closely with the laboratory researchers during the Design Control process to ensure that all regulatory requirements are met prior to submission of clinical protocols. The Design Control process ensures that the proper tests (mechanical, materials, electrical safety, current leakage, biocompatibility and implant) and documentation (failure modes and effects analysis, material stock traceability, design reviews and change management and standard operating procedures) are in place. The regulatory team works with institutional and federal regulatory bodies such as Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and FDA during the submission of clinical and preclinical animal validation protocols and as needed after approval. The team has successfully obtained approval for numerous clinical and preclinical studies, including µOCT imaging in the human gastrointestinal tract, lung, and nares. In addition, Dr. Tearney has a sponsor-investigator FDA IDE for a multicenter intracoronary OCT imaging device study. The team is responsible for monitoring of all ongoing clinical studies and for maintaining records related to clinical device fabrication used in approved clinical studies. The team maintains a data management plan for each study and all clinical data is stored on a dedicated secure server.
Animals. All studies involving vertebrate animals are reviewed by the MGH Institutional Animal Care and Use Committee (IACUC), formerly the Subcommittee on Research Animal Care (SRAC), as required by the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Animals (swine) will be housed in the Edwards Large Animal Facility located in Edward Building, which is immediately adjacent to the Knight Surgical Laboratory. MGH animal facilities are fully accredited by the American Association for the Accreditation of Laboratory Animal Care (AALAC) and all animals are housed in approved areas in accordance with Federal Law (89-544,91-579) and PHS regulations. Veterinary care is provided by the Department of Comparative Medicine at the Center for Comparative Medicine at MGH. A full-time husbandry staff maintains the facility and full-time veterinarians and veterinarian technicians are available on a 24-hour basis year-round. The hospital is registered with the U.S. Department of Agriculture Animal and Plant Health Inspection Service (Certificate No. 4-R-014) and the Massachusetts Department of Public Health (License No. 11-0022) as a licensed animal research facility. MGH files an annual Letter of Assurance (File No. A3596-01) with the NIH Office of Laboratory Animal Welfare confirming compliance with PHS regulations pertaining to laboratory animal care and use. In addition, the hospital has been accredited by the Association for the Assessment and Accreditation on Laboratory Animal Care International (AAALAC) since 1993.
Computers. All instruments are equipped with computers for data acquisition and processing. Software programs for data acquisition (LabView, MS Visual Studio), analysis (Matlab), optical prototyping (Zemax), data visualization (ImageJ & Osirix) and mechanical prototyping (SolidWorks) are available to researchers through volume license agreements. Electronic access to journals is available through the MGH library. The laboratory maintains two secure servers for data storage. Researchers with Harvard Medical School appointments have access to the Harvard University Library System, which includes online journals and databases.
Offices. The Tearney laboratory has approximately 4,000 sq ft of office space. The Laboratory has three full-time administrative staff members that handle purchasing and program management issues. All research office spaces are equipped with phone and high-speed internet capabilities.
Other
Photopathology core: Photopathology is a core facility in the Wellman Center and provides histopathology services to researchers in the Wellman Center and to the greater MGH research community. The facility is staffed by four research technicians with expertise in executing special histological and immunohistochemistry stains, including cyclic immunofluorescence. The core laboratory has expertise in preparing glutaraldehyde-fixed, resin-embedded histology sections for light and transmission electron microscopy. The Core also maintains a Nanozoomer whole slide scanner for digitization of slides and a single- and multiphoton laser scanning confocal fluorescence microscopy instrument (Olympus Fluoview FV1000-MPE).
Advanced Microscopy Center. The facility maintains multiple intravital microscopes (IVM) for confocal and nonlinear microscopy as well as a fluorescence reflectance imaging (FRI) system.
Scientific environment. The proposed research will be conducted at the Wellman Center for Photomedicine located on the main campus of MGH. The Wellman Center is the world’s largest academic research facility dedicated to investigating the effects of light on human biology and to the development of light-mediated, minimally invasive diagnostic and therapeutic technologies. A pioneering laboratory in light-based biomedical research, the Center has been the source of a number of the most successful transfers of this research to clinical applications. Proximity to several renowned universities with doctoral programs in the biomedical and physical sciences facilitates Wellman’s role as a training site for graduate students. Wellman also has established a special affiliate relationship with the Health Sciences and Technology (HST) program at Massachusetts Institute of Technology. All Wellman faculty members have MGH as well as Harvard Medical School (HMS) appointments. The Wellman Center’s location within MGH is an important component of its mission as a translational research center and to the success of the current proposal. The Massachusetts General Hospital is one of the largest teaching hospitals of Harvard Medical School. Proximity to clinicians, institutions such as BWH, MEEI, MIT, and the Wyss Center, and resources including the Center for Nanoscale Systems, supports collaborative biomedical research and facilitates the bench-to-bedside transition that is at the core of Wellman’s mission.