Inflatable Stiffening Dilation Device for PEG Tube Placement
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Solution Overview
Problem
Conventional PEG tube placement procedures are associated with increased risks of esophageal trauma and improper placement due to multiple endoscope passes and flexible catheter sections that can bend, kink, or distort during insertion.
Innovation Solution
A dilation device with inflatable stiffening, dilation, and retention portions, allowing for single incision placement under direct visualization using an endoscope, which includes a continuous pathway for a guide wire and separate inflation lumens for each balloon portion, facilitating atraumatic dilation and stabilization of the catheter tube.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple endoscope passes are used in conventional PEG tube placement, then the procedure can be completed with standard equipment, but the risk of esophageal trauma increases
Solution Approach 1:
The dilation device is divided into three distinct inflatable portions: a stiffening portion, a dilation portion, and a retention portion. Each portion performs a specific function in the tube placement sequence, allowing the procedure to be completed in a single endoscope pass while reducing esophageal trauma risk.
Solution Approach 2:
The stiffening portion is inflated first to provide structural support and prevent catheter kinking before the actual dilation and placement occurs. This preliminary stabilization allows subsequent steps to be performed safely without multiple endoscope passes.
2Ease of operation
If flexible catheter sections are used for PEG tube placement, then the catheter can navigate the body cavity, but the catheter may bend, kink, or distort during insertion
Solution Approach 1:
The stiffening portion is inflated in advance before catheter insertion to provide temporary rigid support. This preliminary action prevents the flexible catheter from bending or kinking during the insertion process, while still allowing the catheter to be flexible when needed for navigation.
Solution Approach 2:
The catheter support system transitions from flexible to rigid and back to flexible through controlled inflation and deflation of the stiffening portion. This dynamic property allows the catheter to be flexible during navigation, rigid during insertion, and flexible again for final positioning.
3Ease of manufacture
If conventional dilation devices with tapered dilators are used, then the needle tract can be dilated, but the dilation process causes trauma to the gastric and abdominal walls
Solution Approach 1:
The dilation portion is inflated with fluid or gas to expand the needle tract in a controlled manner. This pneumatic/hydraulic dilation method is less traumatic than mechanical tapered dilators because it distributes the expansion force evenly and allows for gradual tract enlargement.
Solution Approach 2:
The dilation portion can be inflated to different volumes and pressures to progressively enlarge the needle tract to the required size. This parameter-based control allows for atraumatic dilation by adjusting the inflation parameters to match the tissue's elastic limits.
4Object-affected harmful factors
If a single incision is used for PEG tube placement, then the procedure is less invasive, but the needle tract requires precise dilation to accommodate the catheter
Solution Approach 1:
The dilation portion is inflated to precisely controlled volumes and pressures to enlarge the needle tract to the exact dimensions needed for catheter passage. This precise parameter control ensures the single incision is adequately dilated without causing excessive trauma to surrounding tissues.
Solution Approach 2:
The retention portion provides feedback by anchoring the device against the gastric wall, allowing the operator to sense when the needle tract has been sufficiently dilated and the catheter is properly positioned, ensuring precision in the single-incision approach.
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 dilation device reduces trauma and complications by providing atraumatic dilation and stabilization, allowing for easier and more precise placement of PEG tubes with reduced risk of esophageal trauma and improper placement.
Implementation Method 1
The device includes an inflatable stiffening portion, an inflatable dilation portion, and at least one inflation lumen
Implementation Method 2
The dilation portion is used to dilate the needle tract to create a stoma
Data Source
AI summary
A stoma dilation device that includes a tubular support and an inflatable dilation portion located on the tubular support. The inflatable dilation portion includes a stiffening portion and inflation lumen. The device may have a retention portion configured to have a diameter upon full, unrestrained inflation that is greater than the diameter of the dilation portion. The device is designed to be placed in a patient to dilate the stoma for the installation of a catheter feeding tube. The device may be placed and withdrawn with the use of an endoscope which need be inserted into the patient only one time. The single insertion of the endoscope significantly reduces the trauma to the patient in comparison with multiple endoscope insertion methods.