Multistage Bioabsorbable Plug Sealing Radial Tears
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Solution Overview
Problem
Existing bioabsorbable sealant plug systems and methods are unable to effectively reduce the occurrence of pneumothorax and seal openings in organs like the lung, particularly due to small tears in the lungs during needle insertion.
Innovation Solution
A multistage bioabsorbable plug system comprising a coaxial needle with distinct ports for coagulating agent and plug discharge, where the coagulating agent, which can be patient's blood, is used to seal radial tears, and an expandable biocompatible hydrogel plug is inserted to seal the opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-stage bioabsorbable plug is used to seal puncture openings, then the plug can be inserted and expanded to seal the opening, but it fails to seal radial tears in the lung tissue caused by needle insertion
Solution Approach 1:
The sealing function is divided into two separate components: a coagulating agent delivered through lateral ports to seal radial tears, and an expandable plug delivered through the needle tract to seal the puncture opening. This segmentation allows each component to address specific sealing needs that a single device cannot accomplish alone.
Solution Approach 2:
The coagulating agent is delivered first through the lateral ports before the expandable plug is deployed. This preliminary action seals the radial tears in advance, creating a more effective seal when the plug is subsequently expanded to close the puncture opening.
2Reliability
If blood is used as a coagulating agent to seal radial tears, then sealing effectiveness improves, but control over injection location and efficacy is reduced
Solution Approach 1:
The lateral ports serve as intermediaries that guide and control the delivery of the coagulating agent (blood) to specific locations around the needle tract. This intermediary structure enables precise control over where the coagulating agent is injected, addressing the control issue while maintaining the effectiveness of blood as a sealant.
Solution Approach 2:
The system changes the physical state and delivery parameters of the coagulating agent by forcing it through small lateral ports at controlled rates. This parameter control ensures the coagulating agent is delivered precisely where needed and at appropriate volumes, improving both control and effectiveness.
3Reliability
If existing bioabsorbable plugs are used, then pneumothorax occurrence is reduced, but pneumothorax still occurs in 30% of cases due to unsealed radial tears
Solution Approach 1:
The sealing process is segmented into two stages: first sealing radial tears with coagulating agent, then sealing the puncture opening with the expandable plug. This segmentation addresses both sources of air leakage, preventing pneumothorax more effectively while promoting faster healing by securing both tear and puncture sites.
Solution Approach 2:
Radial tears are sealed preliminarily with the coagulating agent before the plug is deployed. This preliminary sealing prevents air leaks from tears during plug deployment and expansion, ensuring more reliable pneumothorax prevention and faster overall healing.
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 system effectively reduces pneumothorax occurrences by sealing radial tears with the coagulating agent and expanding the hydrogel plug to seal the opening, thereby preventing air leaks and promoting faster healing.
Implementation Method 1
the plug is configured to absorb the coagulating agent
Implementation Method 2
the plug is an expandable biocompatible hydrogel
Implementation Method 3
the coagulating agent, which can be patient's blood, is used to seal radial tears
Data Source
AI summary
A system and method for sealing openings in a body of a patient made by a medical procedure or non-medical event. The opening may be formed in soft tissue, internal organs, or hard tissue. A coaxial needle is inserted into a patient and a coagulating agent is inserted into the patient via the coaxial needle. The coagulating agent is discharged adjacent to the opening and the coaxial needle is inserted to a surgical depth. Following the procedure, the coaxial needle is retracted to a plug discharging depth. A bioabsorbable plug in at least a partially dehydrated state is then discharged from the coaxial needle and the coaxial needle is removed. The plug resides at least partially within the opening in the organ or tissue created by the coaxial needle. The combination of the coagulating agent and the expandable plug seals the opening created by the coaxial needle.