Tissue Puncture Closure Device with Automatic Spool Compaction
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Solution Overview
Problem
Existing tissue puncture closure devices face challenges in ensuring proper placement and sealing of sealing plugs, often resulting in partial seals and prolonged bleeding due to manual compaction issues and sheath removal complications.
Innovation Solution
A tissue puncture closure device featuring an anchor, sealing plug, suture, and automatic driving assembly with first and second spool members, which automatically applies tension to the suture and compaction arrangement to distally advance and compress the sealing plug upon withdrawal, ensuring proper placement and sealing without manual manipulation.
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 only a partial seal and associated late bleeding
Solution Approach 1:
The device performs preliminary compaction of the sealing plug against the tissue puncture site before sheath removal, ensuring the plug is properly positioned and compressed. The compaction tube is advanced to contact and compress the sealing plug while the sheath is still in place, preventing proximal displacement during subsequent sheath removal.
Solution Approach 2:
The compaction tube serves as an intermediary element between the operator and the sealing plug. It provides controlled mechanical force to compress the sealing plug against the tissue puncture site, ensuring reliable sealing while allowing for precise control during the compaction process.
2Ease of operation
If manual compaction is used, then the operator can directly control the compaction process, but the sealing plug may be displaced proximally resulting in partial seals and late bleeding
Solution Approach 1:
The device performs self-compaction through an automatic compaction mechanism that uses the retraction force of the sheath to drive the compaction tube forward. This self-service compaction eliminates the need for manual manipulation after sheath removal, ensuring consistent and precise compression of the sealing plug against the tissue puncture site.
Solution Approach 2:
The compaction system transitions from a static manual process to a dynamic automatic process. The compaction tube is initially held in a retracted position and then automatically advanced using the stored elastic energy from the sheath retraction, providing controlled and precise compaction force without manual intervention.
3Reliability
If automatic compaction is implemented, then sealing reliability is improved, but the device complexity increases with additional spool members and actuation mechanisms
Solution Approach 1:
The spool member serves multiple functions: it stores the compaction tube in a retracted position, provides the mechanical linkage for automatic compaction, and can be used for both deployment and retrieval operations. This multi-functionality reduces the need for separate dedicated components for each function.
Solution Approach 2:
The device uses the potential energy stored in the pre-loaded spring mechanism to drive the compaction process. The spring is compressed during device insertion and then releases this stored energy to automatically advance the compaction tube, eliminating the need for additional power sources or complex actuation systems.
4Ease of operation
If the sealing plug is compacted after sheath removal, then manual access is easier, but the sealing effectiveness is reduced due to plug displacement
Solution Approach 1:
The device performs preliminary compaction of the sealing plug against the tissue puncture site before sheath removal, ensuring the plug is properly positioned and compressed. The compaction tube is advanced to contact and compress the sealing plug while the sheath is still in place, preventing proximal displacement during subsequent sheath removal.
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 achieves reliable and efficient sealing of tissue punctures by automatically advancing and compacting the sealing plug, reducing the risk of partial seals and bleeding, and facilitating easier deployment and ejection of the sealing plug.
Implementation Method 1
Activation of the actuation member releases the first spool member for rotation, thereby applying a tension force in the suture
Implementation Method 2
releases the second spool member for rotation, thereby applying a tension force in the suture, and releases the second spool member for rotation to distally advance a portion of the compaction arrangement to compress or distally advance the sealing plug
Data Source
Figure 1~2
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AI summary
A tissue puncture closure device (200) includes an anchor (208), a sealing plug (210), a suture coupled to the sealing plug, a compaction arrangement (212), and an automatic driving assembly (242). The automatic driving assembly includes first (248) and second spool (250) members and an actuation member. The first spool member is configured to coil a portion of the suture. The second spool member is configured to coil a portion of the compaction arrangement. The actuation member (244) is coupled to the first and second spool members. Activation of the actuation member releases the first spool member for rotation to apply a tension force in the suture, and releases the second spool member for rotation to distally advance a portion of the compaction arrangement to compress the sealing plug.