Biodegradable Anchor Sealing Plug Deployment Device
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Solution Overview
Problem
Current tissue puncture closure tools face challenges in securing the sealing plug effectively, leading to potential leakage due to improper positioning or anchor loosening, which complicates hemostasis after vascular procedures.
Innovation Solution
A deployment device with a biocompatible anchor and sealing plug configuration, where the anchor has a shaft and boss to hold the sealing plug in place, eliminating the need for tamping, and featuring a flexible or semi-flexible anchor with shape memory, along with a suture mechanism for secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional closure tool uses a separate tamping tube and manual tamping procedure to secure the sealing plug, then the sealing plug can be positioned, but the procedure becomes complex and time-consuming requiring multiple steps
Solution Approach 1:
The patent combines the tamping tube and closure tool into a single integrated device. The tamping tube is formed as one piece with the closure tool body, eliminating the need for separate components. This integration maintains the reliable sealing plug positioning function while significantly reducing device complexity and the number of steps required.
Solution Approach 2:
The integrated tamping tube serves multiple functions: it acts as both the delivery mechanism for the sealing plug and the tamping mechanism to secure it in place. This multi-functionality reduces the number of separate devices needed and simplifies the overall closure procedure while maintaining positioning reliability.
2Reliability
If manual tamping is used to secure the sealing plug, then positioning can be achieved, but the procedure requires the carrier tube to be removed first exposing the tamping tube
Solution Approach 1:
By merging the tamping tube with the closure tool body, the patent eliminates the need to remove the carrier tube to access the tamping mechanism. The integrated design allows the tamping function to be performed while the closure tool remains in place, significantly improving ease of operation while maintaining positioning reliability.
3Reliability
If an anchor is used to hold the sealing plug in place, then secure positioning is achieved, but the anchor may loosen and obstruct the lumen over time
Solution Approach 1:
The patent changes the material parameter of the anchor from permanent to biodegradable. The anchor is made of biocompatible material that gradually degrades and resorbs over time, eliminating the risk of long-term obstruction. This parameter change maintains initial positioning reliability while ensuring the anchor does not persist in the lumen indefinitely.
Solution Approach 2:
The biodegradable anchor is designed to be temporarily present to secure the sealing plug during the critical healing period, then gradually discarding itself through biological degradation. This allows the anchor to fulfill its temporary function of holding the sealing plug in place while eliminating the need for long-term presence that could cause obstruction.
4Ease of operation
If the sealing plug is deployed without tamping, then the procedure is simplified, but proper positioning within the puncture tract may be compromised
Solution Approach 1:
The integration of the tamping function into the closure tool body allows for simplified deployment without requiring separate steps. The tamping action is built into the device structure, enabling proper positioning to be achieved through the integrated mechanism rather than requiring multiple separate operations, thus maintaining positioning precision while improving operational simplicity.
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
This configuration ensures secure and easy deployment of the sealing plug, maintaining hemostasis without the need for manual tamping, and allows for quick anchor resorption, reducing the risk of leakage and maintaining vessel patency.
Implementation Method 1
the anchor has a shaft and boss to hold the sealing plug in place
Implementation Method 2
featuring a flexible or semi-flexible anchor with shape memory
Implementation Method 3
along with a suture mechanism for secure placement
Data Source
AI summary
A deployment device for bringing a sealing plug into position within a puncture tract or incision, and bringing an anchor into position adjacent a tissue puncture, is provided. The deployment device is designed to facilitate easier positioning of the sealing plug, wherein a separate tamping tool is not required. The sealing plug is held in place on the shaft of the anchor by a structure, for example, a knob or boss. The anchor, anchor shaft, and sealing plug may be made of various biocompatible resorbable materials such that the anchor may resorb very quickly, leaving the tissue or artery lumen clear, and the sealing plug may resorb more slowly, to assist in maintaining hemostasis. The deployment device may include a bypass device which maintains the anchor in either an extended or bent configuration. Further, the anchor may include at least one rib, to provide support to the anchor.