Percutaneous Puncture Sealing with Expandable Tamponade
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Solution Overview
Problem
Existing medical devices fail to ensure a complete seal of punctures in body tissue after medical procedures, leading to potential complications such as bleeding and infection.
Innovation Solution
A device that uses a multi-stage sealing material delivery system, comprising a temporary sealing component with an expandable tamponading member and a sealing material delivery component, to effectively seal punctures by injecting first and second stages of sealing material into the puncture site, ensuring a secure closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-stage sealing material is used to close a puncture, then the sealing process is simple and quick, but the seal may be incomplete leading to bleeding and infection risks
Solution Approach 1:
The sealing material is divided into two distinct stages: a first sealing material delivered when the expandable member is expanded, and a second sealing material delivered after the expandable member is collapsed. This segmentation allows each material to perform specific functions - the first material provides initial sealing while the expandable member is in place, and the second material ensures complete sealing after removal, thereby improving seal reliability without requiring a fundamentally complex system architecture.
Solution Approach 2:
The first sealing material is delivered in advance while the expandable member is still expanded and providing structural support. This preliminary sealing action prepares the puncture site for the subsequent second sealing material delivery, ensuring that the initial seal is established before the expandable member is collapsed, which improves overall sealing reliability.
2Manufacturing precision
If an expandable member is used to deliver sealing material, then the sealing material can be delivered at the correct location, but the device structure becomes more complex
Solution Approach 1:
The expandable member serves multiple functions: it provides structural support during delivery, acts as a platform for delivering the first sealing material, and its collapse creates the condition for delivering the second sealing material. By making the expandable member multi-functional, the patent improves delivery precision without adding separate dedicated components for each function, thereby limiting the increase in overall device complexity.
Solution Approach 2:
The expandable member transitions between expanded and collapsed states to control the delivery timing and location of sealing materials. This dynamic behavior allows the system to adapt its configuration based on the procedural stage, improving precision by ensuring materials are delivered only when and where needed, while the dynamic nature reduces the need for multiple static components.
3Reliability
If multiple sealing materials are delivered in sequence, then complete sealing is achieved, but the procedure time increases
Solution Approach 1:
The delivery of the second sealing material begins immediately after the collapse of the expandable member, without interrupting the continuous sealing process. The system maintains continuous useful action by seamlessly transitioning from first material delivery to second material delivery, ensuring that the puncture remains sealed throughout the procedure and minimizing non-productive time, thereby reducing overall procedure time while maintaining seal completeness.
Solution Approach 2:
The sealing process uses periodic action by delivering sealing materials at distinct stages: first material delivery during expandable member expansion, then collapse of the member, followed by second material delivery. This periodic delivery pattern ensures thorough sealing at different phases of the procedure, improving reliability while the rhythmic, staged approach prevents unnecessary delays by maintaining a steady procedural pace.
Data Source
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AI summary
A device (112) for sealing a puncture in a patient includes a sealing component (11) and a sealing material delivery component (12). The sealing component (11) includes: an elongate control member (20) configured to pass through a puncture in skin of a patient; an expandable member (21) disposed near a distal end of the elongate control member (20); and a tip (23) releasably attached to the elongate control member (20) distal to the expandable member (21). The sealing material delivery component (12) includes: a delivery tube (60) through which the elongate control member (20) of the sealing component (11) is configured to extend. The delivery tube (60) includes a first cavity configured to deliver a first sealing material (67) to a location near the puncture in the patient when the expandable member (21) in an expanded configuration abuts a surface defining a distal opening of the puncture. A second sealing material (68) is delivered to a location near the first sealing material (67) in the patient, through either the delivery tube (60) or a guide sheath (GS) when the delivery tube (60) and the elongate control member (20) are withdrawn from the guide sheath (GS),