Circumferential Suture Release for Vascular Closure Compaction
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing vascular closure devices face challenges in ensuring proper placement and sealing of sealing plugs at tissue puncture sites, often resulting in partial seals and delayed bleeding due to manual compaction procedures and suture deployment issues.
Innovation Solution
A tissue puncture closure device with an automatic compaction system that includes an anchor, sealing plug, filament, compaction member assembly, spool, stop feature, and release member, allowing for axial compression and automatic compaction of the sealing plug as the closure device is retracted, facilitating full retraction and easy separation from the closure device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the sheath is removed prior to compacting the sealing plug, then the compaction tube is exposed for manual grasping, but the sealing plug may be displaced proximally from the tissue puncture resulting in partial seal and late bleeding
Solution Approach 1:
The system performs the compaction action automatically during device retraction before the sheath is fully removed, ensuring the sealing plug is compacted and secured at the tissue puncture site prior to exposure of the compaction tube. This preliminary automated compaction prevents proximal displacement of the sealing plug that would occur if manual compaction were attempted after sheath removal.
Solution Approach 2:
The compaction tube is designed to compact the sealing plug automatically through its own movement during device retraction, without requiring manual operation. The compaction force is generated self-contained by the relative motion between the compaction tube and sealing plug as the device is withdrawn, eliminating the need for operator intervention and ensuring consistent compaction timing.
2Reliability
If automatic compaction is implemented during device retraction, then complete seal is achieved, but the suture release mechanism becomes more complex
Solution Approach 1:
The suture release mechanism is segmented into distinct functional components: the spool for filament winding, the driving plate for converting retraction motion to spool rotation, the stop feature for controlling rotation, and the release member for operator actuation. This segmentation allows each component to perform its specific function simply, while the overall system achieves reliable automatic compaction and controlled suture release.
Solution Approach 2:
The suture release mechanism transitions from a static, manually-operated system to a dynamic, automatically-actuated system. The spool rotates automatically during device retraction to advance the compaction tube, and the release member dynamically transitions between engaged and disengaged states to control suture release timing based on the retraction position rather than requiring separate manual operation.
3Productivity
If the spool rotates freely to permit full retraction, then the closure device can be fully withdrawn, but the suture cannot be released from the deployment mechanism
Solution Approach 1:
The stop feature is positioned on the spool to automatically engage the release member at the appropriate retraction position, preliminarily controlling the spool rotation to advance the compaction tube to its final position. This preliminary controlled rotation ensures the sealing plug is fully compacted before the suture release mechanism is activated, and the release member can then be easily actuated to permit free spool rotation and suture release.
Solution Approach 2:
The release member acts as an intermediary between the spool rotation and suture release functions. During retraction, the release member is engaged with the stop feature to control spool rotation for compaction. After compaction is complete, the release member is disengaged from the stop feature, serving as a mediator that transitions the system from controlled rotation to free rotation, enabling both full retraction and suture release.
Data Source
AI summary
A tissue puncture closure device includes an anchor, a sealing plug, a filament, a compaction member assembly, a spool, a stop feature, a driving plate, and a release member. The filament attaches the sealing plug to the anchor. The compaction member assembly applies an axially directed compressive force to compact the sealing plug toward the anchor. The spool has a portion of the filament wound thereon. The stop feature is coupled to the spool. The driving plate is connected to the spool and arranged to apply a force to a proximal end of the compaction member assembly upon rotation of the driving plate to advance the compaction member assembly. The release member is operable from a first position contacting the stop feature to limit rotation of the spool, and a second position out of contact with the stop feature to permit rotation of the spool.