Vascular Closure Anchor Assembly with Shape Memory
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Solution Overview
Problem
Conventional methods for closing vascular punctures after medical procedures are inadequate, leading to high rates of post-puncture hemorrhage due to incomplete sealing, which can result in severe complications such as hematoma, exsanguination, and even limb amputation, especially when anticoagulant medications are used.
Innovation Solution
A closure system featuring an anchor assembly with shape memory materials that deploy and retract to securely anchor tissue around the puncture site, allowing for effective sealing without causing significant damage, using a combination of anchor elements and a closure element like a clip or staple to ensure complete closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional manual pressure and pressure bandages are used to close vascular punctures, then the closure method is simple and easy to apply, but the sealing effectiveness is insufficient leading to high rates of post-puncture hemorrhage
Solution Approach 1:
The closure device is divided into multiple functional components: an anchor assembly with expandable anchor portions for securing the device, a closure element (clip or staple) for sealing the puncture, and a delivery system. This segmentation allows each component to perform its specific function optimally, with the anchor providing secure fixation and the closure element providing reliable sealing.
Solution Approach 2:
The anchor portions are deployed into the vessel wall before the closure element is applied. This preliminary action secures the closure device in position and creates a stable foundation for the subsequent sealing action, ensuring that the closure element remains properly positioned during deployment.
2Ease of manufacture
If conventional closure methods are used, then the procedure is quick and simple, but tissue damage is significant and healing is prolonged
Solution Approach 1:
The anchor portions are designed to engage specifically with the vessel wall tissue at the puncture site, concentrating the anchoring action locally rather than requiring broad compression of surrounding tissues. The closure element similarly targets only the puncture opening for sealing, minimizing disruption to adjacent healthy tissue.
Solution Approach 2:
The invention replaces the mechanical compression system (manual pressure and bandages) with a targeted mechanical intervention system that uses precisely positioned anchors and a closure element. This substitution allows for more controlled and localized tissue interaction, reducing unnecessary tissue disruption while maintaining procedural efficiency.
3Reliability
If anticoagulant medications are used to prevent clot formation, then thrombus prevention is improved, but the risk of post-puncture hemorrhage increases
Solution Approach 1:
The closure device provides mechanical support and sealing at the puncture site before the full effect of anticoagulant medications takes hold. The anchor assembly and closure element create a physical barrier that prevents hemorrhage, cushioning against the increased bleeding risk posed by anticoagulant therapy.
4Reliability
If the anchor portions are made to securely anchor tissue, then closure reliability is improved, but tissue damage during deployment increases
Solution Approach 1:
The anchor portions are designed with dynamic deployment characteristics, transitioning from a compressed low-profile state during delivery to an expanded anchored state at the deployment site. This dynamic transformation allows the anchors to penetrate and engage the vessel wall effectively while minimizing tissue disruption during the deployment process, as the expansion occurs only at the target location.
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 system provides reliable and efficient closure of vascular punctures, reducing the risk of hemorrhage and associated complications, while minimizing tissue disruption and allowing for quick wound healing.
Implementation Method 1
the anchor assembly can include an anchor portion configured to be positioned against a distal surface of the tissue wall and having a compressed low-profile configuration and an expanded anchored configuration
Data Source
AI summary
An anchor assembly configured to locate and anchor body tissue surrounding an opening in the body tissue. The anchor assembly can include a plurality of anchor elements. Each anchor element can include an elongate portion and an anchor portion extending from the elongate portion. The elongate portion can be configured to be manipulated by a user. The anchor portion can have a contracted configuration capable of passing through the opening in the body tissue and can have an expanded configuration capable of anchoring the body tissue surrounding the opening. The anchor portion and the elongate portion can be integrally formed from a single wire.