Vibrating Ingestible BioElectronic Stimulator (VIBES)

Technology

VIBES: The technology is in the form of an orally ingestible pill containing a motor and battery, as well as a gelatinous membrane that dissolves 3-5 minutes after immersing in the gastric fluid. The dissolving of this membrane allows a spring-loaded pogo pin to be released, completing an onboard circuit and activating vibration at 80 Hz for roughly 30 minutes. This vibration creates an illusory sensation of stomach filling and distension, stimulating intra-ganglionic laminar endings (IGLEs). These IGLEs are vagal afferents that activate the nucleus of the solitary tract, which is involved in the brain’s hunger circuitry. By triggering the sending of the “satiated” signal to the brain, VIBES alters metabolic hormone production such that the person feels full. This result of these alterations is reduced feeding behavior, as evidenced by the fact that pigs treated with VIBES consumed roughly 50% less of their meal compared to controls.

RoboCap: RoboCap is also an orally ingestible pill, but this device contains a drug payload volume up to 342.6 mm3 in a compartment at one of its ends. When the pill passes through the stomach, gastric fluid causes a gelatinous coating to dissolve, exposing surface features like grooves, fin-shaped cuts, and studded microtexture designed to increase absorption of the drug being delivered. These features allow for rotation in the small intestinal---the folds of the mu-cous membrane---as well as scraping and wicking of mucus. To trigger the device to begin vi-brating and rotating, the mechanism also relies on a dissolvable membrane. When exposed to the pH of the intestinal fluid, this membrane dissolves, allowing device’s circuit to be completed and starting the RoboCap. As the pill rotates, the drug erodes away layer by layer onto the luminal surface.

Problem Addressed

VIBES: Now affecting over 40% of American adults, the obesity epidemic is an increasingly burdensome stressor on the healthcare system. With obesity comes increased risk of diabetes, hypertension, cancer, and heart disease, all of which require the use of healthcare resources. Current weight loss options have their challenges: Behavioral modifications require dramatic life-style changes; bariatric surgery is costly, invasive, and can have complications; pharmacologic therapies have proven inadequate; and intragastric balloons (IGBs) are ineffective in the long-term and pose safety concerns. VIBES aims to provide a method for weight loss that is safer and more effective than these existing options through a vibrating pill that triggers an early sensation of satiety. It has already been successfully tested in pigs and works to reduce food intake.

RoboCap: Oral drug delivery faces the challenge of poor small intestinal absorption. Barriers preventing absorption include the small intestine’s mucus, tight junctions, and microbiota. If drugs have too low bioavailability, or the amount of drug entering into circulation to take effect, when delivered orally, they must be administered in inconvenient ways (by subcutaneous injection, intravenously, etc.) Existing options include microstirring pills to increase absorption speed and bioavailability, as well as mucus-penetrating PEGylated liposomes to increase tissue permeability, though this method must be optimized specifically for each drug. RoboCap is de-signed to locally clear the mucus layer, enhance mixing, and deliver the drug directly to the impacted region to increase drug absorption. Like VIBES, RoboCap has already been successfully tested in pigs, and has been shown to enhance drug absorption.

Advantages

VIBES:

• Promotes weight loss in a non-invasive, convenient, safe way
• Safely passes out of system following vibration for a set time
• Can lower blood sugar through weight loss, helping treat diabetes

RoboCap:

• Ex vivo and in vivo testing revealed an over 10-fold increase in drug permeability for small molecule and peptide drug models using RoboCap
• Increased bioavailability with RoboCap can limit drug dosages, increasing safety and reducing cost
• No biocompatibility concerns and maintains shelf-life and stability of the drug being delivered, unlike other drug carrier systems
• Safely passes out of body after drug delivery
• Also available for licensing is know-how including CAD files, bill of materials and other instructions to accelerate fabrication and testing of the devices.