Endotracheal Tube Support System
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Figure 3: Elbow clip design-Version IV with inner diameter of 9.4 mm
Application Video of Final Design: Elbow clip Version IV
*MATLAB plot by using the data collected through the process in the video.
*Force estimated by force (g) = (FSR reading-77)/0.6142
*The 85º clip decrease the force by approximately 30 g. The clip reduced approximately 43% of the force.
Endotracheal Tube support system---Elbow Clip Design Team
Our team created the Elbow Clip design to be an Endotracheal Tube support which can remove partial pressure from voice-box area. This design could decrease the possible voice-box damage that can be caused by long-term intubation.
As seen in Figure 1 below, we designed an external attachment to the endotracheal tube, which braces the tube to apply additional bending in the tube and aims to utilize the open space close to the vocal cords seen on Figure 1. The attachment will induce bending to a pre-shaped angle of the clip and create an adjustable force at three points on the tube, creating the desired bend and removing pressure from the voice box.
What is Endotracheal Intubation?
Endotracheal intubation is the process of inserting a PVC tube into the trachea through the mouth or nose and establishing an airway to a ventilator to support patients unable to breathe independently. The ventilation system acts as a mechanized diaphragm, inducing airflow into and out of the lungs. The tube itself has a pre-shaped bend to feed down into this portion of the throat smoothly. Our device is designed specifically for the more common form of intubation, which is oral intubation through the mouth.
How would longtime Intubation Cause Side-effects?
When a patient is intubated for a long period of time, such as when a patient is undergoing a lengthy procedure or is comatose, the tube can put pressure on a certain portion of the throat called the posterior larynx leading to the possibility of a recovery period or even permanent damage to the vocal cords that can cause the loss of vocal capability. The posterior larynx is a portion of the throat near the voice box which is made of hard tissue, and is therefore un-malleable and tends to lose blood flow when pressure is applied due to the presence of the endotracheal tube. As depicted in the second figure below, the endotracheal tube sits to the posterior portion of the trachea, pressing up against the posterior larynx. This action leaves a relatively large portion of the trachea open. In the anterior region lie the vocal cords, which are far more malleable to external pressure, and much less likely to be damaged by the presence of the tube.
In these short-term cases, patients often report feeling discomfort or pain in the throat due to the pressure the endotracheal tube puts on the throat. In longer-term cases, such as the treatment of comatose patients, the prolonged pressure can lead to more serious negative effects such as the formation of scar tissue that can cause permanent voice loss or even the permanent loss of the ability to swallow.
What We have?
Design concept----Elbow Clip Design
The Elbow clip design is based on the idea of being “Simple, efficient, affordable.” Figure 3 below presents the CAD model of the design for the 7.0 Hi-Lo Oral/Nasal Tracheal Tube Cuffed Endotracheal Tube made and distributed by Covidien.
Objectives:
The Elbow clip design is aimed to remove pressure from voice box. To achieve this:
Must produce bend in tube when applied
Must relieve pressure from the posterior larynx
Must fit within the prescribed area of application
Must stay secured to the tube
Easy to applicate by anyone under various situation
We end up having array of clips available for a wide range of endotracheal tubes with different sizes and shapes. Additionally, the bending angle of the elbow clip is designed to be easily modifiable, with a selection of desired bending angles available.
Outcomes:
All clips creates effective bending and remove force from the posterior larynx area. For example, the 85º clip decrease the force by approximately 30 g. The clip reduced approximately 43% of the force. The pressure sensor testing would provide more information about this.
According to various Mannequin and cadaver testings, we are confident to say that the 90º entrance is able to let the tube in while securing the clip position
According to USP Class VI and ISO 10993, the PMMA we used is medical grades. The Ansys Granta EduPack: Level 3_Bioengineering Database has been used for material selection.