Aneurysm Neck Coil Structure for Non-Occlusive Flow Restriction
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Solution Overview
Problem
Existing treatments for vascular malformations, such as aneurysms, often result in complete occlusion, intra-operative ruptures, aneurysm recanalization, and increased risk of regrowth due to neck remnants, while minimally invasive methods may cause blockage of neighboring blood vessels and require anti-platelet therapy.
Innovation Solution
A non-occlusive blood restricting device with a single looped wire, featuring a first coil section for the aneurysm sac and a second coil section for the parent vessel, altering blood flow direction and speed without complete occlusion, anchored by an intermediate section, reducing pressure on the aneurysm sac and minimizing vessel blockage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If coils are used to fill the aneurysm sac, then complete occlusion is achieved, but intra-operative ruptures and aneurysm recanalization occur
Solution Approach 1:
The device applies partial action by restricting blood flow to the aneurysm neck rather than achieving complete occlusion. The loop configuration allows controlled flow restriction that promotes gradual thrombosis while avoiding the harmful effects of complete occlusion such as intra-operative ruptures and recanalization.
Solution Approach 2:
The device changes the flow parameters (direction and speed) of blood entering the aneurysm through its loop configuration. This alters the hemodynamic conditions to promote gradual healing without the abrupt pressure changes that cause ruptures during complete occlusion procedures.
2Reliability
If standard coiling is used to treat aneurysms, then complete occlusion is achieved, but aneurysm recanalization occurs in about 30% of cases
Solution Approach 1:
The device uses partial flow restriction rather than complete occlusion, which creates more stable and durable long-term results. By maintaining some flow control through the loop structure, the device prevents recanalization while promoting complete thrombosis over time.
Solution Approach 2:
The loop configuration provides continuous flow restriction and control throughout the treatment process. This continuous action ensures stable thrombosis formation and prevents recanalization, maintaining durable occlusion without the need for additional interventions.
3Reliability
If coils are used to fill the aneurysm sac, then the aneurysm becomes a solid mass, but the delicate aneurysm dome is subjected to direct pressure
Solution Approach 1:
The device extracts the harmful direct pressure effect from the treatment process. By using a loop configuration that restricts flow at the neck rather than filling the sac with coils, the device achieves stabilization without subjecting the delicate aneurysm dome to direct pressure.
Solution Approach 2:
The loop structure acts as an intermediary that controls blood flow to the aneurysm indirectly. Instead of direct contact with the aneurysm dome, the device mediates the flow restriction at the neck level, achieving stabilization without direct pressure on the vulnerable dome.
4Reliability
If stents are used to treat the parent vessel, then blood flow to the aneurysm is restricted, but neighboring blood vessels may be blocked
Solution Approach 1:
The device applies local quality by restricting flow specifically to the aneurysm neck while leaving the parent vessel and neighboring vessels patent. The loop configuration is positioned to affect only the local aneurysm inflow, avoiding blockage of adjacent blood vessels that arise from the parent vessel.
5Reliability
If stents are placed in the parent vessel, then blood flow control is achieved, but anti-platelet therapy is required
Solution Approach 1:
The device extracts the need for anti-platelet therapy by avoiding stent placement in the parent vessel. The loop configuration achieves flow control through mechanical restriction at the aneurysm neck without requiring stents, thereby eliminating the need for prolonged anti-platelet medication and reducing post-procedure management complexity.
Data Source
AI summary
A non-occlusive blood restricting device is provided for delivery by a microcatheter and for treating a vascular malformation. The blood restricting device includes a wire that include first and second sections. The first section is configured to be coiled into a first coil when deployed within the vascular malformation. The first coil includes a spiral or sequence of loops, the spiral or sequence of loops having a gradually decreasing diameter. The first coil is configured to line a neck, a wall, or the neck and the wall of the vascular malformation so as to at least partially cover an orifice of the vascular malformation. The second section is configured to be deployed within a blood vessel, adjacent the vascular malformation. The second section is configured to form a second coil, circumferentially lining a wall of the blood vessel. Other embodiments are also described.