Fiberoptic Angioscope Guidance for Low-Radiation Cerebrovascular Treatment
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Solution Overview
Problem
Existing cerebrovascular pathology treatments face challenges with low first pass success rates, radiation-induced complications, and malpositioned devices due to indirect visualization using external radiographic fluoroscopic imaging, which is inadequate for small and tortuous intracranial vasculature.
Innovation Solution
A forward-viewing fiberoptic angioscope with Coherent Fiber Bundle imaging is used within a sheath catheter to enable real-time, full-color, diagnostic quality intravascular visualization and treatment of cerebrovascular pathologies, stabilized by a distal balloon and featuring a dual concentric lumen structure for flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If external radiographic fluoroscopic imaging is used to guide intravascular instrumentation, then guidance capability is provided, but first pass success rate remains low (25.1%) and radiation exposure occurs
Solution Approach 1:
The patent replaces external radiographic fluoroscopic imaging (mechanical/X-ray based system) with an intravascular imaging system that uses optical fibers and light transmission. The imaging catheter incorporates a coherent fiber bundle that transmits optical images from within the vasculature, substituting the external mechanical imaging system with an internal optical system that provides direct visualization of the pathology and surrounding tissue.
Solution Approach 2:
The patent introduces an imaging catheter as an intermediary device that is inserted into the vasculature to provide direct internal imaging. This intermediary carries the coherent fiber bundle and optical components directly to the target location, serving as a mediator between the imaging system and the pathology, enabling real-time visualization without relying on external fluoroscopy.
2Measurement precision
If radiographic fluoroscopic imaging is used for guidance, then imaging capability is achieved, but radiation-induced complications occur (skin burns, hair loss at 3 Gy)
Solution Approach 1:
The patent substitutes the radiographic fluoroscopic system (which uses ionizing radiation) with an optical imaging system based on coherent fiber bundles and light transmission. This replacement eliminates exposure to ionizing radiation while maintaining the ability to accurately locate and visualize pathologies within the vasculature.
3Ease of operation
If radiographic fluoroscopic imaging is used, then external imaging guidance is provided, but operator radiation exposure occurs (up to 254 Gy to hands and eyes per case)
Solution Approach 1:
The patent replaces the external radiographic fluoroscopy system with an intravascular optical imaging system. This substitution removes the source of ionizing radiation from the operator's environment while preserving the guidance capability through direct internal visualization displayed on external monitors.
4Ease of operation
If fluoroscopic image guidance is used, then procedural guidance is provided, but malpositioned treatment devices occur leading to complications
Solution Approach 1:
The patent replaces external fluoroscopic guidance with internal optical imaging provided by the imaging catheter. The direct visualization of the vessel wall and pathology from within the lumen allows for more precise determination of optimal device placement positions, reducing malpositioning errors.
Solution Approach 2:
The imaging catheter provides real-time visual feedback to the operator during device manipulation and placement. This immediate feedback loop allows the operator to adjust device position based on direct visualization of the pathology and surrounding anatomy, ensuring accurate positioning before treatment delivery.
5Measurement precision
If iodinated contrast agent is introduced for fluoroscopic imaging, then imaging is enabled, but contrast-related nephropathy occurs (20-30% in patients with pre-existing renal disease)
Solution Approach 1:
The patent replaces the iodinated contrast agent-based fluoroscopic imaging system with an optical imaging system using coherent fiber bundles. This substitution eliminates the need for nephrotoxic contrast agents while maintaining the ability to visualize the vasculature and pathology through direct optical transmission.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Achieves 100% first pass success rate in animal models, reduces radiation exposure, and enhances treatment efficacy by allowing real-time adjustments and improved device positioning within small and tortuous intracranial vasculature.
Implementation Method 1
A forward-viewing fiberoptic angioscope such as can include a Coherent Fiber Bundle (CFB) of imaging fibers
Data Source
AI summary
Cerebrovascular treatment at an intracranial location beyond the petrous segment of the carotid artery can be challenging due to blood vessel size and tortuosity. First pass cerebrovascular thrombectomy success rate under only fluoroscopic guidance can be low (e.g., 25.1%) but an angioscope can help improve efficacy. A sheath catheter can be advanced toward the cerebrovascular pathology. Its distal balloon can be inflated. An angioscope can be inserted via its working lumen for viewing. The sheath catheter can have a stepped-down lateral profile and can extend the working channel a distance beyond the balloon. A dual concentric lumen structure can include an inner body and an outer body, defining an inflation lumen therebetween, with one or more portions of one or more layers stretched or cut or both, such as to provide bending flexibility. Reflow techniques can be used to help bond layers together.