Vascular Closure Compaction Tube Pivot Arm
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Solution Overview
Problem
Current vascular closure devices face challenges in accurately locating and deploying sealing plugs to effectively stop bleeding at puncture sites, particularly in femoral arterial punctures, due to difficulties in ejecting and compacting the plugs without advancing them into the vessel.
Innovation Solution
A tissue puncture closure device featuring a compaction assembly with a pivot arm and suture system that applies tension to compact a sealing plug against an anchor, allowing for controlled deployment and sealing of the puncture site, including a carrier tube for plug exposure and a release mechanism for tension adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the sealing plug is ejected at a location in alignment with and adjacent to the tissue puncture, then the sealing plug can be positioned to provide sealing, but it is difficult to compact the sealing plug without advancing it through the tissue puncture into the vessel
Solution Approach 1:
The device separates the sealing plug deployment function from the compaction function. The sealing plug is deployed first to position it adjacent to the tissue puncture, then the compaction member is advanced separately to compact the plug without advancing it through the puncture. This segmentation allows independent optimization of placement precision and compaction ease.
Solution Approach 2:
The compaction member acts as an intermediary tool that applies localized compression force to the sealing plug. It is advanced through the carrier tube to the sealing plug and compacts it by applying force along its longitudinal axis, preventing the plug from advancing through the tissue puncture while achieving effective compaction.
2Reliability
If a compaction member is advanced to compact the sealing plug, then the sealing effectiveness is improved, but the device complexity increases
Solution Approach 1:
The compaction member is integrated with the carrier tube structure, where the carrier tube serves dual purposes: as a delivery conduit for the sealing plug and as a guide/track for the compaction member. The pivot arm mechanism is combined with the suture system, where the suture provides both anchoring function and actuation force for the pivot arm. These mergers reduce overall device complexity while maintaining sealing effectiveness.
Solution Approach 2:
The suture serves multiple functions: it anchors the sealing plug to the tissue, provides the actuation force to rotate the pivot arm, and enables the compaction member to advance. The pivot arm mechanism serves both to actuate the compaction member and to control the suture tension. This multi-functionality reduces the number of separate components needed, thereby reducing device complexity.
3Manufacturing precision
If the pivot arm rotates to apply tension in the suture and advance the compaction tube, then the sealing plug is properly compacted, but the device requires additional components increasing complexity
Solution Approach 1:
The pivot arm provides a dynamic mechanism that converts rotational motion into linear advancement of the compaction tube. The rotation about a pivot point creates a mechanical advantage that amplifies the operator's manual input force, enabling precise control over the compaction process. The release member provides dynamic control, allowing the operator to initiate and control the rotation timing.
Solution Approach 2:
The pivot arm mechanism transforms the one-dimensional linear motion required for compaction into a two-dimensional rotational motion. The operator rotates the release member in an arc, which through the pivot arm geometry, translates into linear advancement of the compaction tube. This dimensional transformation provides mechanical advantage and easier operation.
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 device ensures proper placement and sealing of the puncture site by advancing the compaction tube and applying tension in the suture, effectively reducing bleeding and facilitating healing by maintaining the sealing plug in place.
Implementation Method 1
The pivot arm includes first and second ends and is rotatable about a pivot axis. The proximal end of the compaction tube is connected to the first end of the pivot arm and a proximal end of the suture is connected to the second end of the pivot arm.
Implementation Method 2
The compaction assembly may provide a 1:1 ratio of longitudinal movement of the compaction tube and suture when the pivot arm rotates.
Data Source
AI summary
A tissue puncture closure device includes an anchor, a suture connected to the anchor at a distal end of the suture, a sealing plug positioned proximal of the anchor, and a compaction assembly. The compaction assembly includes a compaction tube having a distal end and a proximal end, and a pivot arm having first and second ends and being rotatable about a pivot axis. The proximal end of the compaction tube is connected to the first end of the pivot arm and a proximal end of the suture is connected to the second end of the pivot arm. The compaction assembly also includes a release member operable to release the pivot arm to rotate between a first position wherein the compaction tube is withdrawn, and a second position wherein tension is applied in the suture and the compaction tube is advanced to compact the sealing plug.