Percutaneous Access Device Balloon Dilation
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Solution Overview
Problem
Existing methods for establishing percutaneous access to the airway, such as tracheostomy, are complex, time-consuming, and require multiple components, making them unsuitable for emergency situations and prone to tissue trauma due to the need for precise manipulation and application of force.
Innovation Solution
A percutaneous access device with a hollow tubular member having segments of varying diameters and a distally tapered design, incorporating an inflatable balloon for dilation, and a deployable needle for forming an opening in the tracheal wall, allowing for efficient and minimally invasive access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional tracheostomy procedures are performed using a scalpel to make a large incision, then an adequate opening is formed for tube insertion, but the procedure requires high surgical skill, causes tissue trauma, and takes considerable time
Solution Approach 1:
The procedure is segmented into distinct steps: initial needle puncture creates a small opening, then sequential dilators (including the device's integrated dilating elements) progressively enlarge the opening to the required size. This segmentation allows precise control over opening formation while simplifying the overall procedure by breaking it into manageable stages rather than requiring a single complex incision
Solution Approach 2:
The device employs nested structures where smaller components are contained within larger ones: the hollow tubular member contains dilating elements that can be deployed outward, and the device itself is inserted through the initial needle opening. This nesting allows the device to deliver progressively larger opening-forming elements through a small initial access point, reducing tissue trauma while achieving the required opening size
2Manufacturing precision
If sequential manipulation of multiple devices (needle, catheter, wire guide, dilator) is performed to dilate the opening, then the opening is enlarged to accommodate the tube, but the procedure becomes time-consuming and complicated
Solution Approach 1:
Multiple functions are merged into a single integrated device: the hollow tubular member combines the functions of initial access delivery, opening dilation (through integrated dilating elements), and tube guidance. This consolidation eliminates the need to sequentially manipulate separate needle, catheter, wire guide, and dilator devices, thereby reducing procedure time and complexity while maintaining precise opening dilation
Solution Approach 2:
The hollow tubular member serves multiple purposes: it acts as the delivery mechanism for the device, provides structural support during insertion, contains the dilating elements, and guides the final tube placement. This multi-functionality reduces the number of separate components needed, streamlining the procedure and reducing the time required while achieving precise opening dilation
3Manufacturing precision
If elongated tapered tubular dilators are used to form the opening, then the opening is effectively dilated, but the pointed distal end risks perforating the posterior tracheal wall
Solution Approach 1:
The dilating elements are designed with non-pointed, distributed contact surfaces that apply radial expansion force evenly across the tracheal wall rather than concentrating force at a single pointed tip. This local quality change in the dilating surface geometry reduces the risk of posterior wall perforation while achieving effective opening dilation
Solution Approach 2:
The hollow tubular member acts as an intermediary structure that controls and distributes the dilating force. Rather than allowing direct application of force from external dilators, the integrated dilating elements within the tubular member mediate the force application, expanding the opening in a controlled manner that reduces the risk of posterior wall injury
4Strength
If considerable force is applied to push the dilator into the trachea, then the dilator penetrates the tough tracheal membrane, but the risk of puncturing the posterior tracheal wall increases
Solution Approach 1:
The device replaces the traditional mechanical pushing force with a controlled expansion mechanism. Rather than forcing a pointed dilator through the tracheal membrane using considerable axial force, the integrated dilating elements expand radially to penetrate and enlarge the opening. This substitution of the mechanical action from axial pushing to radial expansion reduces the risk of posterior wall puncture while maintaining penetration capability
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 device enables rapid and minimally invasive access to the airway by using a balloon for radial dilation, reducing the risk of trauma and simplifying the procedure with fewer components, thus improving the speed and safety of airway establishment.
Implementation Method 1
the uninflated balloon spans the tracheal wall. The balloon is thereafter inflated to radially dilate the opening in the tracheal wall
Data Source
AI summary
A device for providing access through a body wall of a patient to a target site includes a hollow tube having a first large diameter segment and a second small diameter segment. A first distally tapered portion joins the first segment and the second segment, and a second distally tapered portion is distal of the second segment. A first lumen extends through the tube, and a second lumen extends from a proximal portion of the tube to the second segment. A needle received in the first lumen is deployable for piercing the body wall. A port is provided along the second segment in communication with the second lumen, and a balloon is disposed along the second segment at the port. The balloon is inflatable to a diameter at least as large as the first segment diameter for dilating an opening in the body wall.