Endovascular Prosthesis with Retractable Leaf for Aneurysm Occlusion
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Solution Overview
Problem
Current endovascular treatments for aneurysms, particularly those at the distal basilar artery, face challenges due to the need for precise placement and limited rotational range of endovascular prostheses, which can lead to complications such as rupture or incomplete occlusion, and existing methods like surgical clipping and endovascular embolization carry risks of stroke and long-term aneurysm reappearance.
Innovation Solution
A novel endovascular prosthesis with a first expandable portion and a retractable leaf portion, featuring a spine and rib configuration that allows for improved rotational range and flexibility, enabling precise placement and thrombotic occlusion of aneurysms, and can be deployed using a single guidewire for bifurcated arteries, facilitating atraumatic and accurate delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional endovascular embolization techniques are used to treat aneurysms, then the aneurysm can be occluded, but there is a risk of stroke due to distal embolization of the device or clot from the aneurysm
Solution Approach 1:
The prosthesis is divided into distinct functional segments: an expandable body for anchoring and a separate leaf portion for occlusion. This segmentation allows the occlusion function to be performed by the leaf portion that can be positioned within the aneurysm sac, while the expandable body remains in the parent vessel, reducing the risk of distal embolization of entire device components.
Solution Approach 2:
The expandable body acts as an intermediary structure that anchors the prosthesis in the parent vessel without requiring direct manipulation or packing within the aneurysm sac. This intermediary anchoring mechanism eliminates the need for traditional embolization materials that could break loose and cause distal embolization.
2Reliability
If surgical clipping techniques are used to treat aneurysms, then immediate occlusion can be achieved, but the procedure carries high risk and requires the patient to have sufficient strength to survive major surgery
Solution Approach 1:
The invention replaces the mechanical surgical clipping system with an endovascular delivery system. Instead of requiring craniotomy and direct mechanical clipping of the aneurysm neck, the prosthesis is delivered through the vascular system and expanded within the aneurysm, substituting invasive surgical mechanics with less invasive endovascular mechanics.
Solution Approach 2:
The prosthesis provides multiple functions in a single device: anchoring in the parent vessel, occlusion of the aneurysm sac, and potential flow diversion. This multi-functionality replaces the need for separate surgical instruments and procedures, achieving immediate occlusion with a single endovascular intervention rather than major surgery.
3Measurement precision
If endovascular prostheses with limited rotational range are used, then placement precision can be maintained, but the ability to adapt to different aneurysm orientations and positions is reduced
Solution Approach 1:
The prosthesis incorporates dynamic elements including an expandable body that can change shape and a leaf portion that can rotate and adjust its orientation. These dynamic features allow the device to adapt to different aneurysm geometries and orientations after deployment, maintaining placement precision while increasing versatility.
Solution Approach 2:
The leaf portion features an asymmetric design with a spine and ribs that create a non-circular cross-section. This asymmetry provides inherent orientation cues and allows the leaf to rotate into the optimal position for occlusion, enabling adaptation to different aneurysm orientations while maintaining precise placement through the asymmetric geometry's natural alignment properties.
4Reliability
If metal packing materials are used for aneurysm embolization, then occlusion can be achieved, but long-term aneurysm reappearance may occur due to intra-aneurysmal rearrangement of the packing material
Solution Approach 1:
The prosthesis is designed as a permanent implant that discards the need for removable or rearrangeable packing materials. The expandable body and leaf portion form a stable, fixed structure that maintains its configuration over time, eliminating the issue of packing material rearrangement that leads to aneurysm reappearance.
Solution Approach 2:
The prosthesis appears to use composite construction combining different materials with complementary properties: the expandable body likely uses a shape memory or elastic material for anchoring, while the leaf portion uses a more rigid, occlusion-optimized structure. This composite approach provides both immediate occlusion and long-term structural stability to prevent rearrangement.
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 prosthesis provides enhanced rotational range and flexibility for precise placement, reducing the risk of complications like rupture and stroke, and offers a safer alternative to traditional treatments by minimizing the need for metal packing materials, with the potential for improved long-term occlusion and reduced risk of aneurysm reappearance.
Implementation Method 1
a first expandable portion expandable from a first, unexpanded state to a second, expanded state to urge the first expandable portion against a vascular lumen
Data Source
AI summary
There is disclosed a novel endovascular prosthesis that has an improved rotational range of proper placement of the prosthesis with respect to the opening of the aneurysm and provides improved flexibility with respect to longitudinal positioning of the device in the artery. This provides the clinician with a significant advantage over the prior art devices described above. The present elongate endovascular prosthesis comprises a first expandable portion expandable from a first, unexpanded state to a second, expanded state to urge the first expandable portion against the wall of the vascular lumen such as an artery. The endovascular prosthesis further comprises a retractable leaf portion attached to the first expandable portion; the retractable leaf portion serves to facilitate stasis and thrombotic occlusion of the aneurysm. The retractable leaf portion comprises at least one spine portion and a plurality of rib portions attached to the spine portion.