Vascular Hole Closure Device with Intravascular Patch
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Solution Overview
Problem
Current methods for closing vessel openings after vascular procedures are inefficient, requiring prolonged manual pressure, are skill-dependent, and may lead to complications such as leakage or infection, especially for large bore applications in endovascular procedures.
Innovation Solution
A vascular closure device with an intravascular covering member and extravascular retainers, connected by flexible sutures, that can be adjusted to accommodate different tissue thicknesses and apply a consistent clamping force, reducing material usage while maintaining effective sealing without widening the vessel opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to close the vessel opening, then the vessel hole can be closed, but it requires prolonged pressure application time (up to six hours) and increases procedural time and cost
Solution Approach 1:
The closure device is divided into separate functional components: an intravascular covering member (patch) that seals the vessel opening from inside, and extravascular retainers that secure the device from outside the vessel. This segmentation allows the sealing function to be performed independently and quickly by the covering member, eliminating the need for prolonged manual compression.
Solution Approach 2:
The closure device is self-retaining through the interaction between the intravascular covering member and extravascular retainers. Once deployed, the device secures itself without requiring continuous external manual pressure or monitoring, allowing immediate patient ambulation and significantly reducing procedural time.
2Productivity
If suturing devices are used to close the vessel opening, then the closure can be achieved faster, but the surgeon cannot easily visualize the suture due to the depth of the femoral artery, requiring blind knot tying which is skill-dependent
Solution Approach 1:
The suturing step is extracted and replaced by a pre-formed intravascular covering member that is simply deployed into position. The device eliminates the need for the surgeon to manually pass needles and tie knots within the deep vessel, instead using a self-contained patch that seals the opening upon deployment, making the procedure independent of surgical skill.
Solution Approach 2:
The intravascular covering member acts as an intermediary between the vessel opening and the closure mechanism. Rather than requiring the surgeon to directly manipulate sutures within the vessel, the covering member is deployed as a complete sealing unit that can be positioned and secured from outside the vessel using the extravascular retainers.
3Ease of manufacture
If suturing devices are used, then closure can be achieved, but the vessel opening is widened for instrument insertion, creating a bigger opening to close in case of failure
Solution Approach 1:
The intravascular covering member is prepared in advance as a pre-formed patch with appropriate size and shape. This preliminary preparation allows the device to be inserted through a relatively small delivery system without requiring significant widening of the original vessel opening, and the patch is designed to cover the opening effectively once deployed.
4Stress or pressure
If a clamp is used to apply pressure to the vessel opening, then pressure can be maintained, but additional monitoring time is required and procedural cost increases
Solution Approach 1:
The closure device with intravascular covering member and extravascular retainers is self-sustaining once deployed. The mechanical interlocking between components maintains the sealing pressure without requiring external clamps or continuous manual monitoring, allowing immediate patient discharge and eliminating additional procedural time and costs.
Data Source
AI summary
A device for closing an aperture in a vessel wall including a covering member positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture. The covering member has a proximal surface and a distal surface, the distal surface having a concave surface and the proximal surface having a raised surface, wherein four openings are positioned in the raised surface. First and second retainers are positionable external of the vessel and first and second connecting members advance the respective first and second retainers toward the covering member.