Tissue Puncture Closure Device with Automatic Compaction
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Solution Overview
Problem
Existing tissue puncture closure devices face challenges in deploying and properly seating the sealing pad at the tissue puncture site, leading to potential bleeding due to the displacement of the sealing pad during sheath removal before compaction.
Innovation Solution
A tissue puncture closure device with an automatic driving mechanism that includes a filament, anchor, sealing pad, and compaction member, where a biasing member, such as a spring, automatically advances the compaction member to compact the sealing pad upon withdrawal, ensuring proper placement and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the sealing pad is manually deployed and compacted after sheath removal, then the sealing pad can be positioned at the tissue puncture site, but the sealing pad may be displaced proximally during sheath removal resulting in partial seal and bleeding
Solution Approach 1:
The biasing member is pre-loaded in the compressed state during device assembly, storing elastic potential energy ready to drive compaction. This preliminary action ensures that compaction force is automatically applied immediately upon sheath removal, preventing sealing pad displacement and eliminating the need for manual compaction timing coordination.
Solution Approach 2:
The biasing member automatically drives the compaction member to compact the sealing pad without requiring manual operation. The stored elastic energy in the biasing member self-activates upon sheath removal, making the system self-sufficient and eliminating operator dependency for the compaction step.
2Manufacturing precision
If manual compaction is performed, then the sealing pad can be compressed against the tissue puncture, but excessive manual force may cause tissue damage or improper sealing
Solution Approach 1:
The biasing member transforms stored elastic potential energy into controlled mechanical work, automatically regulating compaction force within optimal parameters. This eliminates operator variability and ensures consistent, precise compaction force is applied to achieve proper sealing without tissue damage.
Solution Approach 2:
Manual mechanical compaction by the operator is replaced with an automatic mechanical system driven by the biasing member. This substitution provides more precise and repeatable force control compared to manual operation, improving compaction precision while maintaining appropriate force levels.
3Ease of operation
If the sheath is removed before compaction, then the closure device can be fully deployed, but the sealing pad displacement risk increases
Solution Approach 1:
The biasing member is pre-loaded during device assembly, storing elastic energy ready to drive compaction. This preliminary preparation allows the sheath to be removed first for easy deployment, while the pre-loaded biasing member ensures immediate automatic compaction follows, preventing sealing pad displacement.
Solution Approach 2:
The pre-loaded biasing member creates a counteracting force that anticipates and prevents the harmful effect of sealing pad displacement during sheath removal. By having the compaction mechanism ready to activate immediately, the system counteracts the displacement tendency before it can compromise 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 automatic driving mechanism ensures effective deployment and compaction of the sealing pad, reducing the risk of bleeding and achieving a secure seal at the tissue puncture site with minimal manual force required.
Implementation Method 1
a biasing member, such as a spring, automatically advances the compaction member to compact the sealing pad upon withdrawal
Data Source
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AI summary
A closure device (200) includes a filament (204), an anchor (208), a sealing pad (210), and an automatic driving mechanism. The anchor is configured to be inserted through the tissue wall puncture and is attached to the filament at the second end of the closure device. The sealing pad is slidingly attached to the filament at the second end of the closure device. The automatic driving mechanism includes a compaction member (212), at least one slide member (230, 232) at the first end of the closure device, and a biasing member (234). The biasing member is carried by the at least one slide member and operable to distally advance the compaction member for automatically compacting the sealing pad toward the anchor upon withdrawal of the closure device from the internal tissue wall puncture.