Endovascular Occlusion Device Haemostatic Valve
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Solution Overview
Problem
Current vascular occlusion devices, such as coils and liquid embolics, struggle with proximal occlusion, migration, and non-target embolization, particularly in high-flow and bleeding conditions, and fail to ensure distal small vessel embolization, leading to suboptimal drug delivery and increased risk of complications.
Innovation Solution
An endovascular occlusion device with a deformable sleeve and a conical array of cantilevered arms that form a haemostatic valve, allowing passage of surgical implements while maintaining bidirectional haemostasis, independent of blood flow direction, and featuring an annular support to isolate the valve from sleeve deformations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If coils are used for vascular occlusion, then proximal occlusion is achieved, but distal small vessel embolization cannot be ensured and migration risk increases
Solution Approach 1:
The occlusion device is divided into multiple functional segments: a proximal occlusion element (plug or coil) for proximal vessel occlusion, and a distal embolization element (particle delivery mechanism or liquid embolic system) for distal small vessel embolization. This segmentation allows each component to perform its specialized function independently, resolving the contradiction between reliable proximal occlusion and effective distal embolization.
2Object-affected harmful factors
If liquid embolics are used for distal embolization, then distal small vessel occlusion is achieved, but reflux and non-target embolization risk increase
Solution Approach 1:
The device introduces an intermediary containment structure (catheter system with controlled delivery mechanism) between the liquid embolic and the vascular system. This intermediary allows controlled injection of the liquid embolic directly into distal vessels, preventing reflux by maintaining positive pressure during injection and preventing non-target embolization through precise catheter positioning and controlled flow rate.
3Ease of operation
If vascular plugs are used for occlusion, then recapture and repositioning capability is provided, but distal small vessel embolization cannot be ensured
Solution Approach 1:
The device merges the recapture-capable vascular plug with a distal embolization delivery system into a single integrated device. The plug portion provides proximal occlusion with recapture capability, while the integrated distal delivery system (containing particles or liquid embolic) ensures distal small vessel embolization. The combined device maintains the operational flexibility of recapture while adding the previously missing distal embolization function.
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
Enables safe and controlled distal embolization, reducing the risk of reflux and non-target embolization, allowing precise delivery of therapeutic agents to the desired location, and facilitating repositioning and recapture of the device.
Implementation Method 1
a conical array of cantilevered arms extending from a distal end of the sleeve and converging towards distal tips such as to define a first haemostatic valve
Implementation Method 2
a deformable sleeve displaceable between a collapsed state and an expanded state
Data Source
AI summary
The present invention is concerned with an endovascular occlusion device for use in occluding a lumen of the endovascular system to treat certain medical conditions such as vascular malformations, bleeding vessels or occluding vessels in order to induce tissue ischemia or necrosis, the occlusion device including a deformable sleeve displaceable between a collapsed state and an expanded state and a conical array of cantilevered arms extending from a distal end of the sleeve and converging towards distal tips such as to define a first haemostatic valve about the distal end of the sleeve. The distal end of the sleeve will be at least partially covered with a polymer fluid impermeable membrane in order to provide a seal to prevent fluid flow through the occlusion device. The internal valve will be haemostatic regardless of the initial direction of blood flow and will allow distal endovascular delivery of a surgical instrument such as a catheter that can be manipulated and used to deliver therapeutic agents such as liquid or small particle embolics.