Endovascular Stapler Multi-Point Fixation
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Solution Overview
Problem
Endovascular endografts experience migration issues due to poor patient selection, aortic morphology changes, and device structural fatigue, leading to complications such as Type 1 endoleak, aneurysm sac reperfusion, and renal insufficiency, for which existing fixation methods like hooks and staples are inadequate.
Innovation Solution
An endovascular stapler capable of simultaneously discharging multiple staples, featuring a cage structure with expandable strut members and a non-occlusive balloon for secure fixation of the endograft to the aortic neck, preventing migration and aortic enlargement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional stapling devices discharge one staple at a time, then the device structure remains simple, but the procedure time increases and multiple repositionings are required
Solution Approach 1:
The stapler incorporates multiple staple cartridges arranged in an array, with each cartridge capable of independent actuation. This segmentation allows simultaneous discharge of multiple staples across different locations on the endograft, dramatically increasing stapling productivity while maintaining a manageable structural complexity through modular cartridge design
Solution Approach 2:
The stapler features an expandable cage structure that transitions from a compressed delivery state to an expanded operational state. This dynamic transformation allows the device to accommodate multiple staple cartridges in a compact form during delivery, then expand at the target site to provide sufficient space for simultaneous multi-point stapling, resolving the conflict between productivity and structural complexity
2Reliability
If fixation devices are added to prevent migration, then device security improves, but the risk of complications such as Type 1 endoleak and renal insufficiency increases
Solution Approach 1:
The stapler performs preliminary secure fixation by discharging multiple staples simultaneously at predetermined locations on the endograft before the device is fully deployed. This preliminary action at multiple points creates immediate mechanical anchoring that prevents migration and eliminates the need for additional corrective procedures that could cause complications
Solution Approach 2:
The device combines multiple staple cartridges into a single integrated stapler unit, allowing simultaneous discharge of staples at multiple locations. This merging of multiple fixation functions into one device achieves comprehensive secure fixation while reducing the number of procedural steps and potential complications associated with sequential or multiple device applications
3Reliability
If multiple staples are discharged simultaneously, then fixation security improves and migration is prevented, but the device complexity and procedural difficulty increase
Solution Approach 1:
The expandable cage structure provides a dynamic framework that guides the staple cartridges into proper positioning and alignment automatically during expansion. This self-aligning mechanism simplifies the operator's task by eliminating the need for precise manual positioning of multiple cartridges, thereby maintaining ease of operation while enabling simultaneous multi-point stapling for improved fixation security
Solution Approach 2:
The stapler design allows the expandable cage structure to automatically position and orient the staple cartridges relative to each other and to the endograft surface. This self-positioning capability reduces the procedural complexity and skill requirement for the operator, making simultaneous multi-staple discharge as easy to perform as single-staple devices while achieving superior fixation security
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 endovascular stapler effectively secures the endograft to the vessel, reducing migration and associated complications like Type 1 endoleak and renal insufficiency, while minimizing the need for additional surgical interventions.
Implementation Method 1
a non-occlusive balloon disposed within the confines of the cage structure
Data Source
AI summary
An endovascular stapler (100) for securing an endograft to a vessel is disclosed. The stapler has a staple housing (104), an actuating mechanism (148) and an expansion mechanism (126). The staple housing (104) has a plurality of staple cartridges (128) adapted for storing at least one staple (180) therein. The staple cartridges (128) have an exit area (130) for discharging at least one of the staples (180) therethrough. The actuating assembly (148) is adapted for actuating the plurality of staple cartridges (128) to discharge the at least one staple through the exit area. The expansion mechanism (126) is in operative association with staple cartridges (128). The expansion mechanism (126) is operative for pushing the exit area (130) against the endograft when discharging the at least one staple therethrough.