Aortic Closure Assembly for Larger Puncture Sealing
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Solution Overview
Problem
Existing vascular closure devices struggle with aligning angiographically during procedures and sealing larger punctures in the aorta, particularly when using larger sheaths, due to increased vessel wall defects and external plug exposure to high blood pressure forces.
Innovation Solution
An aortic closure device with a deployment assembly, tamper, sealing element, and suture assembly, controlled by an actuator, allows for remote release and tamping of the sealing element and suture, facilitating efficient sealing of aortic punctures through venous access, using materials like stainless steel, polylactic-coglycolic acid, or biocorrodible iron for the toggle and compressible collagen foam for the plug.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If larger sheaths are used to accommodate larger devices, then device size and aortic access capability are improved, but puncture size increases making sealing more difficult
Solution Approach 1:
The closure device is divided into separate functional components: an intra-arterial toggle component for anchoring, an extra-arterial plug component for sealing, and a connecting suture. This segmentation allows each component to be optimized independently for its specific function while working together to seal larger punctures created by larger sheaths.
Solution Approach 2:
The closure device utilizes composite material construction with the toggle made from absorbable polymers (polylactic-coglycolic acid) or biocorrodible iron, and the plug made from compressible collagen foam. This composite approach combines materials with complementary properties to achieve both secure anchoring and effective sealing in larger vessel defects.
2Reliability
If existing closure devices are used, then puncture sealing is achieved, but alignment during procedure is difficult
Solution Approach 1:
The closure device incorporates radiopaque markers or contrast-enhancing features that become visible under angiographic imaging. This allows real-time visualization and precise alignment of the closure device during the procedure, enabling operators to position the device correctly before final deployment.
Solution Approach 2:
The device design incorporates features that provide visual feedback during deployment through angiographic imaging. Operators can observe the position and alignment of the toggle and plug components in real-time, allowing for adjustments before final sealing is achieved, thereby improving ease of operation during the procedure.
3Force
If external plug is used for sealing, then blood pressure sealing is achieved, but larger defects expose plug to increased forces requiring stronger suture tension
Solution Approach 1:
The closure device separates the sealing function (performed by the extra-arterial plug) from the anchoring function (performed by the intra-arterial toggle). This segmentation allows the plug to be optimized for withstanding blood pressure forces while the toggle provides secure anchoring with reduced suture tension requirements.
Solution Approach 2:
The connecting suture acts as an intermediary element that transfers forces between the intra-arterial toggle and extra-arterial plug. By optimizing the suture tension through proper device design and positioning, the system achieves effective sealing while minimizing the tension requirements on the suture itself.
Data Source
AI summary
An aortic closure device for trans-caval procedures having a deployment assembly having a housing, a release tube, and a delivery tube disposed within the release tube, a tamper disposed within the delivery tube, a sealing element, a suture assembly, and an actuator.