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Anatomic 3D Synthetic Tissue Printer for Medical Training

Description:

OBJECTIVE: Create a multi-substrate 3D printer with the ability to render high-fidelity anatomically accurate synthetic physical tissue models that can be used for anatomy, trauma and surgical training purposes. It is desired that such simulated tissue consist of multiple substances with varying physical properties, so that bone, muscle, vessels, skin and adipose or organ tissue can be simulated. DESCRIPTION: As part of a strategy to lower costs and reduce the use of animal and human cadaveric tissue, this SBIR intends to develop 3D printing technology so that anatomically accurate, multi-substance human tissue analogues can be produced for training purposes. The printer should be able to produce several simulated types of tissue and deposit them in mixed format; i.e., a sample of printed tissue could include hard bone as well as compliant muscle, skin and major blood vessels and perhaps empty spaces within that substrate. If such technology were possible, a wide variety of human anatomy sections could be printed on demand. These simulated anatomy sections could be used for surgery rehearsal, visualization, procedural training and other uses. The actual printed substrates should ideally not be actual biological tissues, but rather materials that simulate their physical properties. PHASE I: At the end of Phase I it is expected that a proof of concept of a 3D printer be demonstrated for multi-substrate deposition, including detailed data on performance of the concept and identify anticipated performance of a more sophisticated working prototype. It is expected that appropriate stimulants be created and tested for bone, muscle, adipose tissue, integument (vessels or tissue planes), skin and possibly organs. Plans for software to be used in the Phase II effort, if the company is selected, should be elucidated. The Phase I proposal must include proposed concept and identify key component technological milestones, have a preliminary methodology on the predicted performance of the printer and printing substrates in addition to a working hypothesis, research methodologies supporting the hypothesis, technical tasks, clinical impact, military impact, and statement of work. The Phase I proposal must also include a target end-consumer cost for the printer if it were to be successfully developed. Similar cost estimates, with practical examples, must be provided for consumables needed to produce anatomical sections. Anticipated resolution must be specified. PHASE II: At the end of Phase II it is expected that a working prototype system will be demonstrated. The working prototype must work with multiple substrates and effectively produce printing outputs that contain at least three types of tissue and empty space areas. The task of creating effective tissue planes (including major vessels) must be definitively addressed. Description of plans, if any, to colorize tissue stimulant materials during printing need to be included in the deliverable Phase II must contain a validation study that examines simulated anatomy output for use in a medical training setting. In addition, the Phase II system must include software tools and anatomy data to allow users to produce a variety of simulated tissue sections. The ability to produce printed tissue output from data of CT and MRI scans is desired. A robust prototype, including 3D anatomy data and consumables, must be delivered for independent testing. Testing of the prototype needs to be performed by an organization that has not participated in the requirements or development. Summary and analysis of data needs to be provided as a Phase II deliverable. PHASE III: Fully robust, ergonomic, cost-effective, manufactured commercialized product. Manufacturing capabilities and scale up plans shall be provided. Test results on robustness, shipping, electrical safety testing, accuracy, consistency, and comparability to current existing methodologies are required. Detailed product cost and consumable cost information is necessary. Specifications of manufactured product as well as manufacturing process need to be prepared and finalized. Materials, material properties, conditions under which product may be shipped and stored are needed.
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