Retractable Ball Segment Braided Implant for Aneurysm Occlusion
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Solution Overview
Problem
Current embolic implants for aneurysm treatment face challenges such as limited access, potential for aneurysm rupture, mass effect on brain tissue, and incomplete occlusion due to issues with embolic coils and neck-occlusive approaches, which can lead to severe complications like recanalization and flow impairment.
Innovation Solution
A braided implant with a retractable dual proximal layer that can be shaped and expanded to occlude the aneurysm neck, featuring a tubular braid that self-expands and includes a heat-treated ellipsoid ball segment for improved conformity and thrombosis, allowing for precise placement and adjustment within the aneurysm sac.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolic coils are delivered to the neck of the aneurysm to occlude the aneurysm, then occlusion of the aneurysm is achieved, but blood flow into peripheral blood vessels may be impeded
Solution Approach 1:
The implant is divided into multiple segments including a first segment that occludes the aneurysm neck and a second segment that maintains patency of the parent vessel. This segmentation allows different portions of the implant to perform different functions - blocking the aneurysm while preserving blood flow to peripheral vessels.
Solution Approach 2:
Different segments of the implant have different structural properties optimized for their specific functions. The first segment has a configuration optimized for occluding the aneurysm neck, while the second segment has a configuration optimized for maintaining parent vessel patency and allowing peripheral blood flow.
2Reliability
If the aneurysm neck is occluded to stop blood flow into the aneurysm, then aneurysm rupture risk is reduced, but blood flow to peripheral vessels may be blocked
Solution Approach 1:
The implant segments the occlusion function from the flow preservation function. The first segment provides occlusion at the aneurysm neck to prevent rupture, while the second segment preserves flow to peripheral vessels, eliminating the harmful effect of flow impairment.
Solution Approach 2:
The second segment acts as an intermediary structure that mediates between the occluded aneurysm neck and the peripheral vessels. It allows blood to bypass the occluded segment and continue flowing to peripheral vessels, preventing flow impairment while maintaining aneurysm occlusion.
3Reliability
If embolic coils are used to fill the aneurysm sac, then aneurysm occlusion is achieved, but mass effect on brain tissue occurs
Solution Approach 1:
The implant extracts the occlusion function from the aneurysm sac itself and places it at the aneurysm neck. By occluding the neck rather than filling the sac, the implant avoids occupying space within the aneurysm sac and exerting mass effect on surrounding brain tissue.
Solution Approach 2:
The implant shifts the occlusion mechanism from a volumetric approach (filling the sac) to a planar approach (occluding the neck). This dimensional change allows occlusion to be achieved at the narrow neck opening without requiring volume occupation within the sac, thereby avoiding mass effect.
4Reliability
If multiple embolic coils are used to treat large aneurysms, then occlusion is attempted, but recanalization occurs due to poor coiling
Solution Approach 1:
The implant establishes a stable occlusion structure at the aneurysm neck before blood can re-enter the aneurysm sac. This preliminary occlusion prevents recanalization by blocking the entry point before flow can re-establish pathways into the aneurysm.
Solution Approach 2:
The implant utilizes a curved or spherical configuration that conforms to the aneurysm neck geometry. This curved structure provides better contact and sealing across the irregular neck opening, preventing blood flow pathways that would lead to recanalization.
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 braided implant effectively secures within the aneurysm sac, providing comprehensive occlusion and reducing the risk of aneurysm rupture and flow impairment, while allowing for repositioning and adjustment to conform to varying aneurysm geometries, enhancing treatment efficacy and safety.
Implementation Method 1
heat-treated ellipsoid ball segment for improved conformity
Data Source
AI summary
The present invention provides a braided implant with a retractable dual proximal layer and methods for administering the braided implant to treat aneurysms. The implant can include a tubular braid that can be set into a predetermined shape, compressed for delivery through a microcatheter, and implanted in at least one implanted position that is based on the predetermined shape and the geometry of the aneurysm in which the braid is implanted. The implant can also have a retractable ball segment at the proximal end of the device made of the same braid that can be heat treated into an ellipsoid shape. The retractable ball segment can be movable from a position outside the aneurysm to a position at least partially enclosed within the implant to increase or decrease the height of the implant relative to the aneurysm or better conform the implant to the neck of the aneurysm.