Percutaneous Access Pathway System for Sterile Pleural Drainage
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Solution Overview
Problem
Current methods for forming and maintaining percutaneous access pathways, such as tube thoracostomy, face challenges including the risk of iatrogenic injury, difficulty in maintaining sterility outside of an operating room, and the need for repeated sterile fields during procedures.
Innovation Solution
The development of devices and methods that create a reusable percutaneous access pathway with a port and catheter system, which can be reversibly sealed to prevent air and infection entry, and includes mechanisms for expansion and contraction to accommodate different sizes and procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a sharp trocar is used to push the chest tube through the chest wall, then the insertion speed is improved, but the risk of lacerating underlying organs increases
Solution Approach 1:
A dilator device is introduced as an intermediary tool between the sharp trocar and the chest tube. The dilator is first inserted through the trocar to create a safe passage, then the chest tube is advanced over the dilator. This mediator prevents direct contact between the sharp trocar and underlying organs while still enabling rapid insertion through the chest wall.
Solution Approach 2:
The insertion process is divided into separate functional steps: first the sharp trocar creates the initial puncture, then the dilator expands the passage safely, and finally the chest tube is advanced. This segmentation allows each component to perform its specific function optimally without compromising safety or speed.
2Object-affected harmful factors
If an open surgical approach with scalpel and forceps is used, then the risk of damaging deeper organs is reduced, but the procedure time and complexity increase
Solution Approach 1:
The dangerous elements (sharp trocar, forceps, scalpel) are extracted from the final insertion sequence and replaced by a controlled mechanical dilator system. The dilator performs the tissue expansion function that previously required manual forceps manipulation, significantly reducing procedure time while maintaining safety.
Solution Approach 2:
The manual mechanical manipulation of forceps and scalpel is replaced by a engineered mechanical dilator system with controlled expansion. The dilator's progressive expansion mechanism provides safer tissue separation with less manual intervention and reduced procedure complexity.
3Reliability
If the chest tube is inserted under a relatively large sterile field, then the sterility is maintained, but the difficulty of maintaining sterility outside the operating room increases
Solution Approach 1:
Instead of requiring a large sterile field for the entire procedure, the sterile barrier is localized to the insertion site. The dilator and chest tube assembly creates a confined sterile zone at the puncture point, allowing the rest of the non-sterile environment to remain unsterile. This localizes the sterility requirement to only the critical insertion area.
Solution Approach 2:
The dilator and associated insertion components are designed as disposable single-use items that are discarded after the procedure. This eliminates the need to maintain sterility in the insertion device itself during transport and storage, as the disposable components are discarded with the patient's waste materials. Only the reusable chest tube requires sterility maintenance.
4Ease of operation
If a reusable percutaneous access pathway with port and catheter system is developed, then the ease of re-access is improved, but the device complexity increases
Solution Approach 1:
The catheter is nested within the port housing, with the entire assembly forming a compact integrated unit. The catheter can be advanced through the port's internal lumen without requiring separate insertion pathways. This nesting arrangement allows the complex reusable system to maintain a simple external appearance and easy operation, as the nested components work together as a single integrated access pathway.
Data Source
AI summary
An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises at least one of three type of components: access pathway, insertion device, and attachment device. In one embodiment, the device is used to form and/or maintain a percutaneous access pathway into the pleural cavity (i.e. tube thoracostomy). The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.