Puncture Closure Device with Expandable Member and Sealing Material
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Solution Overview
Problem
Existing methods for sealing percutaneous punctures in medical procedures often fail to ensure a complete seal, leading to potential complications such as bleeding and incomplete closure.
Innovation Solution
A puncture closure device comprising a delivery member, an expandable member, and a sealing material, where the expandable member temporarily seals the puncture from within the vessel, and the sealing material seals it from outside, using a multi-stage delivery system with different materials and configurations to ensure effective closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-stage sealing method is used, then the device complexity is reduced, but the reliability of complete puncture sealing deteriorates
Solution Approach 1:
The sealing process is divided into two distinct stages: first, an expandable member is deployed from within the vessel to provide immediate temporary sealing; second, sealing material is delivered from outside the vessel through the delivery member to create a permanent seal. This segmentation allows each stage to address specific sealing requirements, ensuring complete puncture closure while maintaining manageable device complexity through modular component design.
Solution Approach 2:
The expandable member is deployed first to temporarily seal the puncture site from within the vessel before the sealing material is delivered. This preliminary action creates a controlled environment that prevents blood flow through the puncture, allowing the subsequent sealing material delivery to proceed effectively and ensuring reliable complete sealing.
2Reliability
If the expandable member is used to temporarily seal the puncture, then the reliability of sealing is improved, but the device complexity increases due to multi-component system
Solution Approach 1:
The expandable member serves multiple functions within the system: it provides temporary sealing of the puncture site, creates backpressure to facilitate sealing material delivery, and acts as a scaffold for the sealing material. This multi-functionality reduces the need for separate components for each function, thereby managing device complexity while maintaining high sealing reliability.
Solution Approach 2:
The delivery member is positioned within the vessel through the puncture site, with the expandable member nested around it. The sealing material is then delivered through the delivery member to the puncture site. This nested configuration allows compact integration of multiple components (delivery member, expandable member, sealing material) while maintaining clear functional separation and ease of deployment.
3Ease of operation
If sealing material is delivered through the delivery member, then the ease of operation is improved, but the reliability of complete seal deteriorates due to potential material leakage into the vessel
Solution Approach 1:
The expandable member is deployed first to temporarily seal the puncture site and create backpressure within the vessel. This preliminary action prevents sealing material from leaking into the vessel during delivery, ensuring that the material remains at the puncture site where it is needed. This approach maintains ease of material delivery through the delivery member while guaranteeing seal completeness.
Solution Approach 2:
The expandable member acts as an intermediary barrier between the sealing material delivery system and the vessel interior. It controls the flow of sealing material, allowing it to be delivered through the delivery member to the puncture site while preventing it from entering the vessel lumen. This intermediary function ensures both ease of operation and reliability of sealing.
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 provides a reliable and complete seal of the puncture, restricting blood flow and ensuring successful closure, with the ability to reattempt closure if initial attempts are unsuccessful, using biocompatible materials and adjustable expandable members to accommodate varying puncture sizes.
Implementation Method 1
The expandable member is positionable within the vessel through a vessel access distinct from the vessel puncture and is operable to temporarily seal closed the vessel puncture from within the vessel to restrict passage of the sealing material into the vessel
Implementation Method 2
The sealing material is deliverable through the delivery member to the vessel puncture and is configured to seal closed the vessel puncture from outside the vessel
Data Source
AI summary
A puncture closure device operable to seal closed a vessel puncture in a vessel. The puncture closure device includes a delivery member insertable through a tissue tract to the vessel puncture, a sealing material, and an expandable member. The sealing material is deliverable through the delivery member to the vessel puncture and configured to seal closed the vessel puncture from outside the vessel. The expandable member is positionable within the vessel through a vessel access distinct from the vessel puncture and is operable to temporarily seal closed the vessel puncture from within the vessel to restrict passage of the sealing material into the vessel.