Percutaneous Access Pathway System with Sterile Segmentation
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Solution Overview
Problem
Existing methods for forming and maintaining percutaneous access pathways in medical procedures, such as tube thoracostomy, face challenges including high infection risk due to large sterile fields required, difficulty in repositioning chest tubes without re-establishing a sterile field, and limitations in performing procedures outside of a sterile operating room.
Innovation Solution
The development of a percutaneous access pathway system that includes a catheter irreversibly attached to a port with a lockable and non-pierceable mechanism, allowing for serial and reversible connections to attachment devices. This system reduces the risk of infection and allows for easier repositioning of access pathways without re-establishing a sterile field.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large sterile field is maintained during chest tube placement, then infection risk is reduced, but procedure time increases and operational complexity increases
Solution Approach 1:
The system divides the chest tube into sterile and non-sterile segments. The distal portion inside the body remains sterile, while the proximal external portion is non-sterile. A sterile barrier (sterile drape or sterile adapter) is placed at the skin interface, separating the sterile internal environment from the non-sterile external environment. This allows the procedure to be completed without maintaining a large sterile field, reducing procedure time while preventing infection.
Solution Approach 2:
A sterile barrier or sterile adapter acts as an intermediary between the sterile chest tube and the non-sterile external environment. This intermediary maintains the sterile field only where needed (at the skin interface and inside the body) while allowing the external portion to be non-sterile, thus reducing the overall sterile field requirement and procedure time.
2Reliability
If a large sterile field is maintained during chest tube placement, then infection risk is reduced, but device complexity increases
Solution Approach 1:
The system segments the chest tube and sterile field requirements. Only the critical interface at the skin and the internal portion require sterility, while the external portion does not. This segmentation simplifies sterile field maintenance from requiring a large area to requiring only a small controlled interface, reducing operational complexity.
Solution Approach 2:
A sterile barrier or adapter serves as an intermediary that maintains sterility at the critical interface without requiring a large sterile field. This intermediary simplifies the complexity of sterile field maintenance by localizing the sterile requirement to a small, manageable area rather than a large field.
3Ease of operation
If the chest tube is moved after initial placement, then proper positioning can be achieved, but infection risk increases due to loss of sterile field
Solution Approach 1:
The chest tube is segmented into sterile and non-sterile portions with a sterile barrier at the interface. When repositioning is needed, the sterile internal portion can be adjusted without compromising sterility, while the external non-sterile portion is manipulated externally. This allows repositioning without re-establishing a large sterile field, maintaining low infection risk.
Solution Approach 2:
The sterile barrier or adapter acts as an intermediary that allows manipulation of the external portion without affecting the sterile internal environment. This enables repositioning of the chest tube while maintaining the sterile field only at the critical interface, thus allowing ease of operation without increasing infection risk.
4Adaptability or versatility
If the chest tube is made long and floppy to reach the pleural space, then access to body cavities is improved, but infection risk increases due to contact with non-sterile surfaces
Solution Approach 1:
The chest tube is segmented into a long flexible internal portion and a shorter external portion, with a sterile barrier at the interface. The long flexible internal portion can reach the pleural space without the entire tube needing to be sterile. Only the portion inside the body and the interface require sterility, allowing the long floppy design while minimizing infection risk.
Solution Approach 2:
A sterile barrier or adapter acts as an intermediary that separates the long flexible tube into sterile and non-sterile zones. This allows the tube to be long and floppy for better access capability while the sterile barrier prevents contamination from the non-sterile external portion, thus maintaining reliability.
Data Source
AI summary
An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises an access pathway and attachment device. The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.