SBIR-STTR Award

The goal of this program is the development of a high-resolution, neuroendovascular imaging platform that provides detailed information on intravascular devices used to treat brain aneurysms. Miniaturization of the design features of neurovascular stents and flow-diverters (FD) with braided wires of 20 ?m and laser cut features of 10 ?m, has enabled an explosion of technology available for endovascular treatment of stroke. Despite these advances, however, several questions remain unanswered including the mechanisms of aneurysm rupture after FD treatment, the fate of jailed perforating vessels and long term patency rates. Non-invasive imaging technology has not kept pace with device technology to enable endovascular surgeons sufficient resolution to adequately assess the device-vessel relationship. As such, there is a critical need for high resolution imaging specific to cerebrovascular disease and endovascular treatments. Intra-vascular optical coherence tomography (OCT) is a relatively new imaging technique approved by FDA for the coronary vasculature imaging that delivers the highest axial resolution (~10-15 µm) among all other available modalities. However, commercially available OCT catheter sizes (~2.6F – 1 mm) are not compatible with microcatheters used for neuro-endovascular intervention do not allow for navigation in the highly tortuous neurovascular anatomy. In this application we seek to develop a reduced size, high-resolution imaging catheter compatible with neurovascular microcatheter delivery tools and workflow, capable of navigating tortuous vasculature using novel optics and scanning mechanisms. We aim to demonstrate feasibility in a combination of in vitro vascular phantoms of cerebrovascular pathology and in vivo animals model including cutting edge neuroendovascular implants. Upon completion of this Phase 1 application, we will have sufficient preliminary data showing the superiority of intravascular OCT imaging as compared to gold standard x-ray angiography and cone-beam CT to enter into a commercialization phase that will seek regulatory approval for the technology.

Public Health Relevance Statement:
NARRATIVE Recent advances in endovascular treatments for brain aneurysms include new technology such as endoluminal flow diverters, endosaccular flow disrupters, and bifurcation stents for assisted coil embolization. However, imaging technology does not have sufficient resolution for proper positioning of the devices with respect to the lesion and prevention of device malapposition that may lead to thromboembolic complications. Several questions remain unanswered, including the mechanisms of aneurysm rupture after endovascular treatment, prevention of distal thromboembolic events during intervention, the fate of jailed perforating vessels and long term patency rates. Current imaging technologies lack sufficient resolution to adequately assess neurovascular device-vessel relationship and arteries microstructure and to date no neurovascular imaging modality is available to precisely identify device characteristics. In this application we seek to develop a reduced size, high-resolution imaging probe compatible with neurovascular microcatheter delivery tools, capable of navigating tortuous vasculature using novel optics and scanning mechanisms and demonstrate it in vivo.

Project Terms:
Address; Alloys; Anatomy; Aneurysm; Angiography; Angioplasty; Animal Model; aortic arch; Arteries; Atherosclerosis; Automobile Driving; Benchmarking; Blood; Blood Vessels; brachial artery; Brain Aneurysms; Caliber; Catheters; cerebrovascular; Cerebrovascular Disorders; cerebrovascular imaging; Characteristics; commercialization; cone-beam computed tomography; Coronary; cost; Data; design; Development; Devices; Diagnostic radiologic examination; Digital Subtraction Angiography; Dissection; Distal; Engineering; Enteral; Evaluation; Event; Explosion; Family suidae; FDA approved; flexibility; follow-up; Goals; Gold; high resolution imaging; Human; Image; image guided; Imagery; Imaging Device; imaging modality; imaging platform; imaging probe; imaging system; Imaging Techniques; Imaging technology; Implant; implantation; improved; In Situ; In Vitro; in vivo; in vivo imaging; Intervention; intracranial artery; Jail; Lasers; Lead; Length; Lesion; maxillary artery; Measures; member; Methodology; middle cerebral artery; Miniaturization; minimally invasive; Modality; Modeling; Morphology; neurosurgery; neurovascular; new technology; nitinol; non-invasive imaging; novel; Optical Coherence Tomography; Optics; Pathology; Patients; Perforating Artery; Peripheral; Phase; Platinum; Positioning Attribute; Prevention; programs; Protocols documentation; Resolution; Risk; Roentgen Rays; Rotation; Ruptured Aneurysm; Scanning; Site; Speed; Stents; stroke treatment; Surgeon; System; Techniques; Technology; technology development; Testing; Therapeutic Embolization; Thrombosis; Time; tool; Torque; treatment planning; treatment response

This program will commercialize a high-speed, high-resolution, neuroendovascular imaging platform that allows neurointerventionalists to directly visualize intravascular devices and their interaction with vessels during treatment of brain aneurysms. The miniaturization of the design features of neurovascular stents and flow-diverters has enabled an explosion of technologies available for endovascular treatment of stroke. However, imaging technology has not kept pace with device technology to enable endovascular surgeons sufficient resolution to adequately visualize the device-vessel relationship. As such, there is a critical need for high-resolution imaging specific to cerebrovascular disease and endovascular treatments. Optical coherence tomography (OCT) is a relatively new imaging technique approved by FDA for intracoronary imaging that delivers the highest axial resolution (?12 µm) among all the other available modalities. However, commercially available OCT solutions are not compatible with microcatheters used for neuro-endovascular intervention and are unsuitable for highly tortuous neurovascular anatomy. During SBIR Phase I, Gentuity demonstrated a reduced size, high-resolution, high-frequency OCT imaging probe designed for cerebrovascular imaging (the Vis-N device). The Vis-N is compatible with neurovascular microcatheter delivery tools and workflow and can navigate tortuous vasculature using novel optics and scanning mechanisms. We successfully demonstrated the feasibility of the proposed technology in a combination of in vitro vascular phantoms and in vivo pre-clinical models, including cutting edge neuroendovascular implants. The aim of the submitted project is to further develop the proposed imaging device for clinical use and to demonstrate its safety and efficacy in a pre-clinical model. Upon completion of this Phase 2 application, we will be poised to study this neurovascular imaging catheter in an IDE to obtain regulatory approval and enter the commercialization phase. !

Thesaurus Terms:
Address; Anatomy; Aneurysm; Angiography; Animals; Arteries; Automobile Driving; Biomaterial Compatibility; Blood Vessels; Brain Aneurysms; Brain Hemorrhage; Brain Repair; Caliber; Catheters; Cerebrovascular Disorders; Cerebrovascular Imaging; Clinic; Clinical; Commercialization; Cone-Beam Computed Tomography; Design; Device Or Instrument Development; Devices; Diagnosis; Elastases; Engineering; Evaluation; Explosion; Family Suidae; Fda Approved; Follow-Up; Frequencies; Funding; Goals; High Resolution Imaging; Histopathology; Image; Image Guided; Imagery; Imaging Device; Imaging Modality; Imaging Platform; Imaging Probe; Imaging Techniques; Imaging Technology; Implant; Implantation; Improved; In Vitro; In Vivo; Innovation; Intervention; Joints; Magnetic Resonance Imaging; Measures; Miniaturization; Minimally Invasive; Modality; Modeling; Morphologic Artifacts; Neurovascular; Novel; Optical Coherence Tomography; Optical Imaging; Optics; Organ; Outcome; Pathology; Perioperative; Phase; Positioning Attribute; Pre-Clinical Model; Preclinical Safety; Procedures; Process; Programs; Prototype; Radiation; Repaired; Resolution; Response; Risk; Roentgen Rays; Rotation; Safety; Scanning; Small Business Innovation Research Grant; Speed; Stents; Sterilization; Stroke Treatment; Surgeon; System; Techniques; Technology; Technology Development; Tensile Strength; Testing; Therapeutic; Tool; Treatment Planning; Treatment Response; X-Ray Computed Tomography;