Automatic Tamping Mechanism for Vascular Closure Sealing
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Solution Overview
Problem
Existing tissue puncture closure devices require manual tamping of sealing plugs, which can lead to partial seals and delayed bleeding due to displacement of the sealing plug during sheath removal, hindering proper placement and causing bleeding from the tissue puncture site.
Innovation Solution
A tissue puncture closure device with an automatic tamping mechanism that drives a sealing plug toward an anchor upon withdrawal, using a gear train and transducer to apply a tamping force, ensuring secure placement and sealing without manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual tamping is used to place the sealing plug, then the device structure can be simpler, but the sealing reliability deteriorates due to plug displacement during sheath removal
Solution Approach 1:
The automatic tamping mechanism performs the tamping action in advance during the withdrawal phase, before the sheath is fully removed. The mechanism is pre-positioned within the sheath and automatically activates upon withdrawal, ensuring the plug is secured before manual intervention is needed.
Solution Approach 2:
The closure device performs its own tamping function through an automatic mechanism that uses the withdrawal motion itself to drive the tamping action. The system is self-sufficient, requiring no external manual operation for tamping, thereby improving reliability while maintaining reasonable complexity.
2Ease of operation
If the sheath is removed before tamping, then the tamping tube can be accessed for manual operation, but the sealing plug may be displaced proximally resulting in partial seal
Solution Approach 1:
The automatic tamping mechanism performs the critical tamping action before the sheath is completely removed. The mechanism is designed to activate during the withdrawal process itself, ensuring the plug is securely positioned before any manual access is needed, thus preventing displacement.
Solution Approach 2:
The automatic tamping mechanism serves as an intermediary between the withdrawal motion and the final plug positioning. It translates the withdrawal motion into a controlled tamping action, ensuring proper plug placement without requiring direct manual manipulation that could cause displacement.
3Reliability
If automatic tamping mechanism is added to the closure device, then the sealing reliability improves, but the device complexity increases
Solution Approach 1:
The automatic tamping mechanism is integrated into the existing closure device structure, allowing the same device to perform multiple functions: maintaining plug position during insertion, providing automatic tamping during withdrawal, and enabling easy separation afterward. This multi-functionality justifies the added complexity by delivering multiple benefits from a single integrated system.
Solution Approach 2:
The tamping mechanism is merged with the sheath and closure device components rather than being a separate independent system. The mechanism uses the existing withdrawal motion of the sheath to drive the tamping action, combining what would otherwise be separate operations into a single integrated function.
4Reliability
If the automatic tamping mechanism remains engaged during full retraction, then continuous tamping force is maintained, but the separation of closure device components becomes difficult
Solution Approach 1:
The engagement state of the automatic tamping mechanism is dynamic rather than static. The mechanism automatically transitions from an engaged state during withdrawal and tamping to a disengaged state during full retraction and separation. This dynamic behavior allows the system to adapt to different operational phases, maintaining sealing reliability when needed while enabling easy separation when required.
Solution Approach 2:
The tamping mechanism operates in periodic cycles: engaged during withdrawal and tamping phases, then disengaged during retraction and separation phases. This periodic engagement and disengagement allows the system to provide continuous sealing force when needed while facilitating component separation when the procedure is complete.
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 automatic tamping mechanism ensures a complete and secure seal at the tissue puncture site, reducing bleeding and facilitating easy separation of the closure device components, thereby improving the efficacy of vascular closure procedures.
Implementation Method 1
The transducer may include a first gear and spool assembly with a portion of the filament wound thereon, and a tamping tube driver directly or indirectly driven by the first gear. As the spool rotates in response to retraction of the closure device, it drives the first gear in a first direction, and the first gear drives the tamping tube driver directly or indirectly in a second direction.
Implementation Method 2
The gear train is capable of transducing a retraction force in a first direction into a distal force on the sealing plug in a second direction upon withdrawal of the closure device from the internal tissue wall puncture.
Data Source
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AI summary
A method and apparatus for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The method and apparatus provide for disengagable automatic tamping and/or cinching of the sealing plug when the apparatus is withdrawn from the puncture site. The disengagable automatic tamping and/or cinching is facilitated by transducing a motive force generated by the withdrawal of the apparatus into a tamping and/or cinching force.