Stoma-creating Apparatus with Segmented Dilation for Tracheal Safety
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Solution Overview
Problem
Current tracheostomy procedures often result in damage to the posterior tracheal wall and fracture of tracheal rings due to excessive force, require experienced clinicians to perform with both hands, and involve complications like stoma closure after device removal, necessitating improved apparatus for creating and maintaining stomas during procedures like tracheostomy and pneumothorax treatment.
Innovation Solution
A stoma-creating apparatus with first and second members that move between closed and open configurations, featuring dilation means for gradual and controlled dilation, reducing discomfort and complications by eliminating the need for blind insertion and downward pressure, and allowing for easier attachment of medical devices like tracheostomy tubes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If sequential dilators are forced into the tracheal wall over the guide wire, then a stoma of sufficient size is created, but the posterior wall of the trachea is damaged and the tracheal rings are often fractured
Solution Approach 1:
The dilation process is divided into multiple sequential steps using progressively larger dilators (first dilator, second dilator, third dilator) rather than forcing a single large dilator through. Each dilator is inserted in sequence over the guide wire, allowing gradual expansion that prevents tracheal wall damage and ring fracture while achieving the required stoma size.
Solution Approach 2:
A guide wire is inserted into the trachea through the needle and sheath before any dilation takes place. This guide wire serves as a preliminary structure that provides a safe pathway for subsequent dilators, preventing blind insertion and ensuring proper positioning throughout the dilation process.
2Productivity
If a single tapered dilator is used instead of sequential dilators, then the number of insertion steps is reduced, but a substantial amount of force is needed which can result in the trachea collapsing and the tracheal rings becoming fractured
Solution Approach 1:
The single large dilator is segmented into multiple smaller dilators of progressively larger sizes. This allows the trachea to be expanded gradually in controlled increments rather than subjected to the substantial force required for a single large dilator, preventing tracheal collapse and ring fracture while maintaining procedural efficiency.
Solution Approach 2:
Instead of applying excessive force with a single large dilator, the procedure uses multiple dilators that each apply a smaller, controlled amount of force. The cumulative effect of these partial actions achieves the same end result (adequate stoma size) without the harmful excessive force that causes tracheal collapse.
3Volume of moving object
If forceps dilation is used to create the tracheal stoma, then the stoma can be formed between the tracheal rings, but force is placed on the joining tissue between the cartilage rings which risks tearing the tissue in a non-uniform manner
Solution Approach 1:
The dilation process is segmented into multiple controlled steps using sequentially larger dilators rather than a single forceps dilation action. This gradual expansion distributes the mechanical stress uniformly across the tissue, preventing non-uniform tearing of the joining tissue between cartilage rings while still achieving adequate stoma formation.
4Ease of manufacture
If the initial device to create the stoma is removed from the patient, then the stoma tends to close up, but the clinician has to carefully prise it back open before the tracheostomy tube can be inserted
Solution Approach 1:
The guide wire is inserted as a preliminary action before dilation and remains in place throughout the procedure. When the dilators are removed, the guide wire maintains the stoma patent, preventing closure. This eliminates the need to carefully re-prise the stoma open and provides a continuous pathway for inserting the tracheostomy tube.
Solution Approach 2:
The guide wire serves as an intermediary structure that maintains the stoma open during device removal and tube insertion. It acts as a mediator between the removal of the dilating device and the insertion of the tracheostomy tube, preventing stoma collapse and simplifying the transition between steps.
5Reliability
If tracheostomy procedures are performed using conventional techniques, then the stoma can be created, but the procedure must be carried out by an experienced clinician who must use both hands
Solution Approach 1:
The guide wire acts as an intermediary that provides a fixed reference pathway through the trachea. This allows the clinician to work with one hand for dilation and tube insertion while the guide wire maintains proper positioning, reducing the complexity and skill requirement compared to conventional two-handed techniques.
Solution Approach 2:
The complex manual manipulation required in conventional techniques is replaced by a more systematic approach using the guide wire as a mechanical guide. The dilators and tube are simply pushed over the guide wire in sequence, replacing the need for experienced manual dexterity and two-handed coordination.
Data Source
AI summary
The invention provides a stoma-creating apparatus for creating a stoma in a subject. The apparatus comprises first and second members, and one or more dilation means provided on the first and/or second member. In use, upon respective movement of the first and second members, the stoma-creating apparatus is arranged to move between a first closed configuration in which the one or more dilation means is substantially closed, and a second open configuration in which the one or more dilation means is substantially dilated, thereby creating a stoma in the subject. The invention is particularly concerned with creating stomas which hold a tracheostomy tube in position on the trachea of a patient undergoing a tracheostomy, or for securing a valve or other medical device in position adjacent a patient's pneumothorax.