Radiopaque Wire Pre-Shaped Bend for Endovascular Implant Positioning
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Solution Overview
Problem
Current methods for precise placement of endovascular implants at confluence points are time-consuming, require excessive radiation and contrast use, and are prone to inaccuracies due to operator skill dependence and limitations in fluoroscopic visibility, especially in venous systems where flow and contrast media dynamics are complex.
Innovation Solution
A positioning apparatus featuring a sheath with dual lumens and a radiopaque wire with a pre-shaped bend that guides the implant into position, allowing for precise visualization under fluoroscopy without contrast injection or respiratory motion issues, reducing procedure time and radiation exposure while enhancing accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional fluoroscopy imaging techniques are used for implant positioning, then the operator can visualize the implant placement, but the procedure is time-consuming and requires additional radiation exposure and contrast media
Solution Approach 1:
The wire is pre-shaped with a predetermined configuration (such as a bend or curve) that corresponds to the desired implant position before the procedure. This pre-shaped wire serves as a positioning tool that visually indicates the exact location where the implant should be deployed, eliminating the need for time-consuming fluoroscopy-based mental reconstruction during the procedure.
Solution Approach 2:
The pre-shaped wire acts as an intermediary tool between the operator and the implant positioning task. Instead of directly visualizing the implant through fluoroscopy, the wire provides a visible, tactile reference that mediates the positioning process, allowing the operator to accurately place the implant without repeated fluoroscopy images.
2Measurement precision
If multiple fluoroscopy images are obtained to understand the three-dimensional anatomy, then the operator can assemble a mental understanding of the vessel orientation, but additional radiation exposure and contrast media are required
Solution Approach 1:
The pre-shaped wire provides its own visual indication of the positioning location without requiring external fluoroscopy imaging. The wire's predetermined shape self-indicates the correct implant position through its visible configuration, eliminating the need for multiple fluoroscopy images and contrast media to understand vessel orientation.
3Measurement precision
If the wire is made radiopaque for visualization under fluoroscopy, then the positioning is visible, but the wire complexity increases
Solution Approach 1:
The wire is made radiopaque only in specific local regions where visualization is needed, rather than throughout its entire length. This localized radiopacity provides sufficient visibility for positioning while minimizing the overall complexity and material usage of the wire structure.
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
The apparatus enables reliable and accurate positioning of endovascular implants, improving operator success and reducing costs and complexity, by providing continuous positioning feedback during stent deployment and release, and allowing for precise control of implant extension to avoid blockages.
Implementation Method 1
An at least partially radiopaque wire is located in the second lumen. The at least partially radiopaque wire includes a pre-shaped portion for positioning at the junction for use in guiding the endovascular implant into position within the branch.
Data Source
AI summary
An apparatus is for positioning an endovascular implant, such as a stent to assist in maintaining vessel patency, adjacent a junction at a branch from a vessel. A sheath includes a first lumen and a second lumen. The first lumen is adapted for receiving a catheter including the endovascular implant for positioning within the branch. An at least partially radiopaque wire is located in the second lumen. The at least partially radiopaque wire includes a pre-shaped portion, such as a bend, for locating at the junction for use in guiding the stent into position within the branch. Related methods are also disclosed.