Vascular Prosthesis Delivery Spool Wire Management
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Solution Overview
Problem
Current systems for delivering endoluminal prostheses, such as vascular stents and stent grafts, face challenges in accessing and implanting side branches within blood vessels efficiently, requiring long preloaded wires that complicate procedures, increase radiation exposure, and pose risks due to the need for additional personnel and potential misalignment with blood flow.
Innovation Solution
A system featuring a delivery catheter with a preloaded wire coiled onto a spool at the handle, extending through the prosthesis to side branches within the main lumen, allowing for easier access and alignment with blood flow, reducing the need for long wires and minimizing procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If long preloaded wires are used to access side branches, then the prosthesis can be delivered to the target site, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The prosthesis is divided into multiple segments including main body, side branches, and fenestrations. Each side branch is equipped with its own preloaded wire that can be independently controlled. This segmentation allows the operator to access specific side branches without manipulating the entire prosthesis system, reducing procedural complexity while maintaining reliable access.
Solution Approach 2:
The wires are preloaded through the prosthesis during manufacturing or preparation, with distal ends positioned at the distal opening and proximal ends coiled on spools. This preliminary action ensures that wires are already in place and properly positioned before the procedure begins, eliminating the need for time-consuming intra-procedural wire insertion and reducing overall procedure complexity.
2Reliability
If long preloaded wires are used to reach side branches, then complete coverage is achieved, but radiation exposure and procedure time increase
Solution Approach 1:
Wires are preloaded and positioned during preparation rather than during the procedure. The distal ends are positioned at the distal opening and proximal ends coiled on spools before patient intervention. This eliminates time-consuming wire insertion steps during the procedure, reducing procedure time while ensuring complete side branch coverage is achieved.
Solution Approach 2:
The system allows dynamic control of individual wires through spools at the handle. Operators can selectively deploy or retract specific wires as needed during the procedure, rather than having all wires extended throughout. This dynamic control reduces the time needed for wire manipulation and minimizes radiation exposure by allowing selective activation.
3Reliability
If additional personnel are used to manage long preloaded wires, then wire function and sterility are ensured, but device complexity and procedural difficulty increase
Solution Approach 1:
Multiple wire control functions are merged into a single integrated handle assembly with spools. All wire manipulation functions (deployment, retraction, positioning) are combined in one location that can be operated by a single user. This integration maintains reliable wire function and sterility while eliminating the need for additional personnel, thereby improving ease of operation.
Solution Approach 2:
The handle with spools serves multiple functions: it stores the wires in a sterile state, controls wire deployment and retraction, and maintains wire tension. This multi-functional design consolidates tasks that would otherwise require multiple personnel into a single universal interface, improving procedural ease while maintaining wire reliability.
4Ease of operation
If pivot fenestrations are used to access side branches, then wire access is enabled, but the risk of procedure failure increases
Solution Approach 1:
The fenestrations and wire pathways are predetermined and prepared during prosthesis manufacturing. Wires are preloaded through these fenestrations with distal ends positioned at the distal opening. This preliminary preparation eliminates the need for intra-procedural pivot maneuvers or complex wire routing through fenestrations, thereby improving procedure success while maintaining ease of wire access.
Solution Approach 2:
Instead of maneuvering wires through fenestrations from the proximal side (which requires pivot actions and increases failure risk), the wire distal ends are positioned at the distal opening and wires are pulled back through the fenestrations. This inverted approach simplifies wire access while eliminating the need for risky pivot maneuvers, thereby improving both ease of operation and procedure reliability.
Data Source
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AI summary
The present invention relates to a system for delivery of an endoluminal prosthesis, the system comprising a delivery catheter and a prosthesis to be delivered, wherein the system comprises a wire extending through at least a portion of a main lumen of the prosthesis in a preloaded configuration, the wire extending in distal direction to a position in proximity to the distal opening of the prosthesis and the wire extending in proximal direction of the proximal opening of the prosthesis along the catheter shaft up to the handle, wherein the handle comprises at least one spool to receive the proximal end of the preloaded wire with a proximal portion of the preloaded wire being coiled onto the spool.