Vascular Closure Tissue Lock for Calcified Access Sites
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Solution Overview
Problem
Existing vascular closure methods are time-consuming and prone to complications such as hematoma or thrombosis, especially in the presence of vascular diseases like atherosclerosis and calcification, and current devices have high failure rates.
Innovation Solution
A vascular closure device with elongated housing and engagement members that deploy and retract to close the passage through tissue proximate to the blood vessel without engaging the vessel wall, using sutures or flexible tension elements to create a tissue lock, and optionally includes an anvil member for reference and hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing closure methods (external compression, suture devices, plugs) are used, then vascular access can be closed, but the procedure becomes time-consuming and consumes significant procedure time
Solution Approach 1:
The closure device is divided into multiple independent engagement members (first engagement member, second engagement member) that can be deployed and positioned separately. Each engagement member can independently engage with tissue at different locations, allowing parallel processing of closure actions and reducing overall procedure time while maintaining reliable closure through distributed engagement points.
Solution Approach 2:
The device employs dynamic deployment and retraction mechanisms where engagement members can be deployed to engaged contact with tissue and then retracted to close the passage. The retraction member enables controlled movement of engagement members from deployed to retracted positions, allowing the system to transition between open and closed states efficiently, reducing closure time while maintaining effectiveness.
2Reliability
If suture-mediated closure devices are used, then vascular access can be closed, but failure rates increase in the presence of atherosclerosis and calcification
Solution Approach 1:
The engagement members act as intermediaries between the closure mechanism and the vascular tissue. Instead of directly engaging with the vessel wall (which is affected by atherosclerosis and calcification), the engagement members engage with surrounding tissue to create a tissue lock that indirectly closes the passage, bypassing the problematic vascular wall conditions and reducing failure rates.
Solution Approach 2:
The invention extracts the closure function from direct vessel wall engagement and relocates it to surrounding tissue engagement. By taking out the engagement action from the vascular wall and applying it to adjacent tissue, the device eliminates the harmful interaction with diseased vascular surfaces while maintaining effective closure through the created tissue lock.
3Reliability
If existing closure methods are used, then vascular access can be closed, but complications such as hematoma or thrombosis occur
Solution Approach 1:
The engagement members serve as intermediaries that engage with surrounding tissue rather than directly with the vascular wall. This intermediary approach creates a tissue lock that closes the passage without generating harmful mechanical stress on the vessel wall, thereby reducing the risk of complications such as hematoma and thrombosis while maintaining closure effectiveness.
4Reliability
If prior site preparation is performed, then closure can be achieved, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The engagement members are pre-positioned within the device housing in a ready-to-deploy configuration. The deployment members are pre-loaded to deliver engagement members to the tissue upon activation. This preliminary arrangement eliminates the need for complex prior site preparation, as the closure mechanism is prepared in advance and can be activated immediately upon insertion, reducing both complexity and time requirements.
Data Source
AI summary
The present disclosure relates to a vascular closure device adapted for use in closing a puncture in a blood vessel after e.g. a percutaneous interventional procedure. The disclosure also relates to a method for vascular closure using such a vascular closure device.