SBIR-STTR Award

Safe and reliable access to major blood vessels and internal organs will be beneficial to patients with cardiovascular disease and cancer. An interventional catheter with ultrasound imaging capability will be developed to enable image-guided access to blood vessels and internal organs. Computer simulations and preliminary data using a transducer similar to that proposed for the study suggest a high likelihood of success. This Phase 1 STTR proposal seeks to develop a working prototype of the device and demonstrate feasibility of the device in its exemplary clinical uses in in-vitro gel phantoms. We will build a high frequency, small aperture forward viewing ultrasound transducer, characterize it and test it with various iterations of plastic multi-lumen catheters in a standardized gel phantom. In particular, studies will seek to demonstrate the device ability to track the device tip in real-time and guide it to specific targets in the gel phantom. This phase 1 proposal will provide proof of concept and select the best candidate prototype for phase 2 studies. No such device is currently available in the market and the successful development of a clinically implementable device has immense commercial potential by its ability to contribute significantly to the advancement and expansion of minimally invasive medical procedures.

Public Health Relevance:
This Phase 1 STTR proposal seeks to develop a working prototype of an ultrasound guided, interventional device and to demonstrate feasibility of the device in particular exemplary clinical uses in in-vitro gel phantoms.

Thesaurus Terms:
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Safe and reliable access to major blood vessels and internal organs will be beneficial to patients with cardiovascular disease and cancer. An interventional catheter with forward viewing ultrasound imaging capability will be developed to enable image-guided access to blood vessels and internal organs. Phase 1 experiments demonstrate feasibility of building a high resolution, forward viewing ultrasound array and its ability to yield clinical quality images of ex-vivo tissue. This Phase 2 SBIR proposal seeks to build on the Phase 1 results and develop a clinical prototype of the device. Furthermore, we will demonstrate feasibility and safety of the device in its exemplary clinical uses in pre- clinical testing and in proof of concept human studies. We will build a high frequency, small aperture forward viewing ultrasound transducer, characterize it and test it with various iterations of plastc multi-lumen catheters in experimental models and humans. In particular, studies will seek to demonstrate the device ability to track the device tip in real-time and guide it to specific target in the model and human studies. This phase 2 proposal will provide experimental, pre-clinical and clinical proof of concept and requisite data to select the best candidate prototype for clinica use and will position the device for regulatory approval and sale. No such device is currently available in the market and the successful development of a clinically implementable device has immense commercial potential by its ability to contribute significantly to the advancement and expansion of minimally invasive medical procedures.

Public Health Relevance Statement:


Public Health Relevance:
This Phase 2 SBIR proposal seeks to develop a clinical prototype of an ultrasound guided, interventional device and to demonstrate feasibility and safety of the device for particular exemplary clinical uses in experimental models and pilot human testing.

Project Terms:
Adoption; base; Bathing; Biological; Biopsy; Bladder; Blood Vessels; body system; Cannulations; Capital; Cardiovascular Diseases; Caring; Catheters; Cessation of life; Clinical; clinical practice; commercial application; Complication; cost; Coupled; Data; design; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Management; Drainage procedure; Elements; Emergency Situation; Evaluation; Experimental Models; Family suidae; femoral artery; Femoral vein; Frequencies (time pattern); Funding; Goals; Hand; Heart; Heart Diseases; Human; Image; image guided intervention; Imagery; improved; in vivo; Infection; innovation; instrument; Interventional Ultrasonography; Kidney; Legal patent; Life; Liquid substance; Liver; liver biopsy; Liver diseases; Local Therapy; Lung; Lung diseases; Magnetic Resonance; Malignant Neoplasms; Marketing; Mechanics; Medical; minimally invasive; Modeling; Needles; novel; Organ; Outcome; patient safety; Patients; Pericardial body location; Pericardiocentesis; Phase; Physicians; Pleural; point of care; Population; Positioning Attribute; pre-clinical; Procedures; product development; Productivity; prototype; public health medicine (field); public health relevance; research clinical testing; research study; Resolution; Safety; safety testing; Sales; Site; Skin; Small Business Innovation Research Grant; Source; Structure; success; Surveys; System; Techniques; Technology; Testing; Time; Tissues; Transducers; Ultrasonic Transducer; Ultrasonography; United States; United States Food and Drug Administration; Validation; Water; whole body imaging; X-Ray Computed Tomography