Endoscopic Needle System for Edulis Therapeutics

Inserting a solid implant through an endoscope is an unprecedented approach in the field of Gastroenterology. Previously, only fluid medications had been put through an endoscopic needle. Edulis Therapeutics developed an implant for the gastrointestinal system that can help provide maintenance free treatment for those with chronic conditions. After multiple iterations and experiments, our team developed a prototype for the company that can reliably insert a 100 mg implant into the submucosa of the intestine. It is compatible with a conventional endoscope with a 2.8 mm working channel, eliminates the need for separate loading of the implant and saline, optimizes the implant size, and simplifies the procedure for the physician.

The design of our first prototype was the concentric needles and we tried to base the overall housing off of the current needle they are using, the Echotip Ultra Endoscopic Ultrasound Needle. There are three main housings: one that is fixed to the tubing, one that is fixed to the sheathing, and finally one that stabilizes the entire system to the endoscopic working channel. The purpose of multiple housings is to allow for the sheathing to be adjusted to allow for more or less of the needle to be revealed. When putting the tubing through an endoscope’s working channel, the needle must be sheathed in order to prevent damage to the working channel and to allow for easy insertion through the working channel. The sheathing and tubing housing can be moved with thumbscrews to affix each housing in place.

The second prototype of our needle solved many of the challenges observed in testing the first prototype. The junction between saline and filament tubing was improved significantly, now providing enough sealing to be used to create a saline pocket. The ergonomics were improved to allow a single operator to perform pocketing and insertion with relative ease. And lastly, the maximum diameter of inserted filament was doubled to 1 mm while dropping the diameter of the full tubing stack from 6.2mm down to 4.8mm. This new revision of the needle solidified most of the major design elements used in our final prototype. Testing proved that, while usable, modifications to the selected epoxy and tubing sizes would be required to produce a more robust final model.

The final prototype contains multiple design features that help fulfill our original project requirements and goals.
Proprietary Concentric Needle and Housing: Our final prototype was a functioning proprietary submucosal endoscopic insertion system with a concentric needle design. The ergonomic design prioritizes usability for gastroenterologists, so that it can easily be operated by one individual. The prototype also includes a concentric needle design, where the filament tubing slips into a piercing needle so that only one needle insertion is needed to both deliver saline and insert a solid medication implant.
Loading Saline and Medication: Another design requirement for our final prototype was to increase the convenience of loading saline and medication through the endoscope. This was achieved, as medication and saline are loaded through the two openings at the top of the device. Using our system, both the medication and saline can be pre-loaded before our system is even inserted into the endoscope, increasing the ease of usability for the doctor.
System through Endoscope: The system is able to fit through a Standard Olympus endoscope with a 2.8mm working channel. The addition of needle sheathing ensures that the device slips into the endoscope easily without causing damage to the endoscope or the needle. The system and endoscope can be operated with 1-2 individuals. The needle is retractable, and can protrude up to 5 cm outside of the endoscope.