Vascular Closure Device with Retaining Element and Tether
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Solution Overview
Problem
Existing vascular closure devices often result in complications such as haematoma, pseudo-aneurysms, arteriovenous fistulae, access-site related bleeding, and acute ipsilateral leg ischaemia, and pose a risk of local infections, necessitating a simpler and more effective solution for sealing vascular access holes.
Innovation Solution
A self-expanding tubular vascular closure device with a retaining element and tether system that allows for controlled expansion and anchoring within the blood vessel, using a simpler structure and bioresorbable materials to minimize complications and infection risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vascular stent graft is placed on the inside of the blood vessel to close the vascular access hole, then the vascular access hole is sealed from the inside, but complications such as haematoma, pseudo-aneurysms, arteriovenous fistulae, access-site related bleeding, and acute ipsilateral leg ischaemia may arise
Solution Approach 1:
The closure device is divided into separate functional components: a stent graft for sealing the vascular access hole from the inside, and a separate closure element that pushes against the hole from the outside. This segmentation allows each component to perform its specific function optimally while reducing the risk of complications associated with single-component systems.
Solution Approach 2:
A closure element acts as an intermediary component between the stent graft and the vascular access hole. This closure element is positioned outside the blood vessel and pushes against the vascular access hole to seal it, providing an additional sealing mechanism that reduces the risk of complications such as haematoma and pseudo-aneurysms.
2Reliability
If a complex vascular closure device structure is used to prevent complications, then sealing effectiveness improves, but the device structure becomes more complex and harder to manufacture
Solution Approach 1:
The device is segmented into distinct modular components (stent graft and closure element) that can be manufactured separately using optimized processes for each component, then assembled. This modular approach simplifies manufacturing compared to creating a single complex integrated device, while maintaining high sealing effectiveness.
Solution Approach 2:
The stent graft serves multiple functions: it provides structural support, seals the vascular access hole from the inside, and can be configured to prevent complications. This multi-functionality reduces the need for additional complex components, simplifying the overall device structure while maintaining reliability.
3Reliability
If a vascular closure device is deployed to seal the vascular access hole, then bleeding is stopped, but the risk of creating local infections needs to be minimized
Solution Approach 1:
The closure element is designed to be removed or absorbed after serving its sealing function. By extracting or eliminating the closure element after use, the device minimizes the risk of long-term infection while maintaining effective bleeding control during the critical healing period.
Solution Approach 2:
The closure element is designed as a temporary, disposable component that performs its sealing function and then is removed or absorbed. This approach minimizes infection risk by avoiding permanent foreign bodies in the vascular system, while still providing effective bleeding control during the acute phase.
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 solution effectively seals vascular access holes with reduced risk of complications and infections, facilitating easier deployment and user-friendly operation while allowing for natural healing and minimizing long-term impact on the blood vessel.
Implementation Method 1
By the vascular closure element being self-expanding, it is meant that the vascular closure element will, when heated to a temperature of around the human body temperature, expand by itself without the need for, say, an inflatable balloon or some other kind of external means for expanding it.
Implementation Method 2
the retaining elements restrains the vascular closure element and will hold the vascular closure element in a configuration in which the vascular closure element is not fully self-expanded. This restraining function will also function whilst the assembly of the vascular closure element and the retaining element is inserted into a patient's vasculature
Data Source
AI summary
The present invention relates to a vascular closure device, comprising a self-expanding tubular vascular closure element, a retaining element surrounding the vascular closure element, the retaining element being arranged to hold the vascular closure element in the lumen of the retaining element in a configuration where the vascular closure element is not fully self-expanded, a tether that is threaded through the lumen of the retaining element, the tether being arranged so that, upon application of a first force to the tether which is greater than a threshold force, the tether disintegrates the retaining element so as to allow the vascular closure element to freely expand. It also relates to a system for delivering such a vascular closure device and to a method of closing a vascular access hole using a corresponding device.