Background

In 2014, 34.9% of American adults were shown to be obese. Obesity greatly increases the risk for type II diabetes, among many other diseases. One well-established surgical intervention for type II diabetes is the weightless surgery gastric bypass. This surgery removes a large portion of stomach and the upper portion of small intestine (duodenum), and then connects the jejunum to the remainder of the stomach. However, this is a very invasive procedure with surgical risks including potential bleeding and infection. In addition, there are a number of serious risks after gastric bypass surgery, such as blockage of the digestive system and infection inside the abdomen.  Therefore, we are seeking an improved solution that mimics gastric bypass with less risks.

Nasoduodenal Feeding Tube

One possible solution is a nasoduodenal feeding tube.  The placement of a nasoduodenal feeding tube will have a similar effect as gastric bypass surgery without any physical modification to the stomach or small intestine, thereby maintaining the integrity of the digestive system and preventing bacterial translocation. Some initial studies have shown that after placing a nasoduodenal feeding tube for a period of time, patients with Type II diabetes experience great improvement of their condition or even complete recovery.

Figure 1. Nasoduodenal feeding tube.

Confirmation of Placement

Current procedures to confirm nasoduodenal feeding tube placement usually requires confirmation by X-ray fluoroscopy. In this procedure, the patient is exposed to radiation every time he or she needs an insertion of the feeding tube. We need a better way to assess successful placement without heavily exposing patients to radiation.

Existing System

There exists only one device with FDA approval for feeding tube placement confirmation without the use of X-ray.  The tip of the stylet contains an electromagnetic transmitter that generates a signal as the feeding tube advances to the desired position.  A receiver placed on the patient’s xiphoid process detects the signal, and the monitor displays a real-time representation of the feeding tube tip’s passage.  However, this device does not provide a very confident confirmation of placement.  It only gives the tip’s relative position in space, not absolute.

Our Design

Our product will accomplish the goal of accurately determining the position of the nasoduodenal feeding tube, without the drawbacks of the existing system. Through the combination separate technologies, the absolute position will be able to be determined with a high degree of confidence.

Our device will likely incorporate the use of ultrasound imaging. The tip of the tubing will be lined with a metal or other high-density material that will be clearly seen by ultrasound. While it will be biocompatible at the very least, this material will ideally be biodegradable, so that it is eliminated from the body following longterm placement.

Another possible feature of our device is a simple camera that will be placed on the end of the tube. Similar to cameras used in endoscopies and colonoscopies, this camera will provide the health care provider placing the device with a video feed of the patient’s gastrointestinal tract throughout the procedure, allowing for accurate placement and visualization of any unexpected complications. After the tube has been placed, the camera could then be unattached and pulled back up through the tube itself, allowing the device to be used in other placements, as well as removing the device from the patient, and therefore avoiding possible risks, such as infection or the obstruction of food flow.

Finally, our device will likely utilize physiological sensors. These elements of the placement system will provide the health care provider placing the feeding tube with relevant information such as pH, temperature, and GI motility. While these sensors will not provide an absolute location of the feeding tube, as the previous two elements will, the sensors will help confirm the accurate placement of the device, as the readouts can be compared to appropriate ranges.