Catheter Imaging for Vascular Access Precision
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Solution Overview
Problem
Current methods for creating vascular access sites for hemodialysis are prone to inaccuracies, leading to unnecessary vessel injury and unsuitable openings due to the lack of precise localization and visualization of artery and vein proximity during surgical procedures.
Innovation Solution
The use of intravascular imaging and spectral analysis to guide the formation of vascular access sites, allowing for simultaneous visualization of both vessels and characterization of tissue and blood flow, thereby determining ideal locations for fistula formation and reducing the risk of injury and unsuitable openings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If surgical procedures are performed without intravascular imaging guidance, then the procedure can be performed with simpler equipment, but the precision of vessel localization and opening creation is insufficient leading to unnecessary vessel injury and unsuitable openings
Solution Approach 1:
The imaging assembly is nested within the catheter body, with the imaging transducer positioned at the distal end of the catheter. This allows the imaging system to be delivered through the same vascular access route as the catheter itself, integrating two functions (imaging and intervention) into a single deliverable system without requiring separate large-bore access or complex external imaging equipment
Solution Approach 2:
The imaging assembly acts as an intermediary between the operator and the target vessels, providing real-time visual feedback about vessel anatomy, proximity, and needle trajectory. This intermediary system enables precise localization and guidance of the needle through the catheter wall into the target vessel without direct visual exposure of the surgical field
2Productivity
If a needle is deployed through the walls of both vein and artery without imaging guidance, then the procedure is faster, but the risk of creating unsuitable openings and vessel injury increases
Solution Approach 1:
The imaging assembly is advanced to the target site and imaging is performed before needle deployment to identify the optimal puncture location where the vein and artery are in close proximity. This preliminary imaging step ensures that subsequent needle insertion will create suitably positioned openings for fistula formation, preventing the need for repeat procedures
Solution Approach 2:
Real-time imaging feedback is provided during needle deployment to confirm proper needle trajectory and penetration into the target vessel. The imaging system allows visualization of the needle tip position relative to the vessel walls, providing immediate feedback to adjust the procedure and ensure suitable opening creation while maintaining procedural efficiency
3Ease of operation
If the artery and vein are not visualized during the procedure, then the equipment and procedure are simpler, but the ability to determine ideal locations for fistula formation is reduced
Solution Approach 1:
The imaging assembly integrates multiple imaging modalities (ultrasound and optical coherence tomography) within a single catheter system, combining the benefits of both imaging types to provide comprehensive vessel visualization. This merged system delivers detailed anatomical information while maintaining a single integrated device that does not significantly complicate the overall procedure
Data Source
AI summary
The invention generally relates to catheter systems and methods for guided formation of vascular access sites (such as fistulas and grafts). According to certain aspects, a catheter system for forming a vascular access site include an elongate body comprising a distal end and configured to be inserted into a first vessel. The elongate body includes an exit port along its side that is proximal to the distal end. An imaging assembly is associated with the elongate body and configured to generate image data of the first vessel and a second vessel positioned next to the first vessel. For vascular access formation, a penetrating member of the catheter system extends out of the exit port and through a wall of the first vessel and a wall of the second vessel.