Electronic pill can relay diagnostic information or release drugs in response to smartphone commands

MIT researchers have designed an ingestible sensor that can lodge in the stomach for a few weeks and communicate wirelessly with an external device.
Image courtesy of the researchers

Ingestible capsule can be controlled wirelessly

Researchers at MIT, Draper, and Brigham and Women’s Hospital have designed an ingestible capsule that can be controlled using Bluetooth wireless technology. The capsule, which can be customized to deliver drugs, sense environmental conditions, or both, can reside in the stomach for at least a month, transmitting information and responding to instructions from a user’s smartphone.

The capsules, manufactured using 3-D-printing technology, could be deployed to deliver drugs to treat a variety of diseases, particularly in cases where drugs must be taken over a long period of time. They could also be designed to sense infections, allergic reactions, or other events, and then release a drug in response.

“Our system could provide closed-loop monitoring and treatment, whereby a signal can help guide the delivery of a drug or tuning the dose of a drug,” says Giovanni Traverso, a visiting scientist in MIT’s Department of Mechanical Engineering, where he will be joining the faculty in 2019.

These devices could also be used to communicate with other wearable and implantable medical devices, which could pool information to be communicated to the patient’s or doctor’s smartphone.

“We are excited about this demonstration of 3-D printing and of how ingestible technologies can help people through novel devices that facilitate mobile health applications,” says Robert Langer, the David H. Koch Institute Professor and a member of MIT’s Koch Institute for Integrative Cancer Research.

Langer and Traverso are the senior authors of the study, which appears in the Dec. 13 issue of Advanced Materials Technologies. Yong Lin Kong, a former MIT postdoc who is now an assistant professor at the University of Utah, is the paper’s lead author.

Wireless communication

For the past several years, Langer, Traverso, and their colleagues have been working on a variety of ingestible sensors and drug delivery capsules, which they believe would be useful for long-term delivery of drugs that currently have to be injected. They could also help patients to maintain the strict dosing regimens required for patients with HIV or malaria.

In their latest study, the researchers set out to combine many of the features they had previously developed. In 2016, the researchers designed a star-shaped capsule with six arms that fold up before being encased in a smooth capsule. After being swallowed, the capsule dissolves and the arms expand, allowing the device to lodge in the stomach. Similarly, the new device unfolds into a Y-shape after being swallowed. This enables the device to remain the stomach for about a month, before it breaks into smaller pieces and passes through the digestive tract.

One of these arms includes four small compartments that can be loaded with a variety of drugs. These drugs can be packaged within polymers that allow them to be released gradually over several days. The researchers also anticipate that they could design the compartments to be opened remotely through wireless Bluetooth communication.

The device can also carry sensors that monitor the gastric environment and relay information via a wireless signal. In previous work, the researchers designed sensors that can detect vital signs such as heart rate and breathing rate. In this paper, they demonstrated that the capsule could be used to monitor temperature and relay that information directly to a smartphone within arm’s length.

“The limited connection range is a desirable security enhancement,” Kong says. “The self-isolation of wireless signal strength within the user’s physical space could shield the device from unwanted connections, providing a physical isolation for additional security and privacy protection.”

To enable the manufacturing of all of these complex elements, the researchers decided to 3-D print the capsules. This approach allowed them to easily incorporate all of the various components carried by the capsules, and to build the capsule from alternating layers of stiff and flexible polymers, which helps it to withstand the acidic environment of the stomach.

“Multimaterials 3-D printing is a highly versatile manufacturing technology that can create unique multicomponent architectures and functional devices, which cannot be fabricated with conventional manufacturing techniques,” Kong says. “We can potentially create customized ingestible electronics where the gastric residence period can be tailored based on a specific medical application, which could lead to a personalized diagnostic and treatment that is widely accessible.”

Early response

The researchers envision that this type of sensor could be used to diagnose early signs of disease and then respond with the appropriate medication. For example, it could be used to monitor certain people at high risk for infection, such as patients who are receiving chemotherapy or immunosuppressive drugs. If infection is detected, the capsule could begin releasing antibiotics. Or, the device could be designed to release antihistamines when it detects an allergic reaction.

“We’re really excited about the potential for gastric resident electronics to serve as platforms for mobile health to help patients remotely,” Traverso says.

The current version of the device is powered by a small silver oxide battery. However, the researchers are exploring the possibility of replacing the battery with alternative power sources, such as an external antenna or stomach acid.

The researchers are also working on developing other kinds of sensors that could be incorporated into the capsules. In this paper, they tested the temperature sensor in pigs, and they estimate that within about two years, they may be able to start testing ingestible sensors in human patients. They have launched a company that is working on developing the technology for human use.

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Electronic Pill Reality

via rdmag.com

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In today’s world, it’s an exciting time for medical technology. And making smart use of modern digital innovations is bringing revolutions in health care for the young and old.

The ability to combine information and function from various devices to personalize treatment based on individual conditions presents enormous opportunity to both improve health and reduce costs. And these trends support the demands for individuals to assume greater control and ownership of their own health state.

One concept related to these trends is that of an electronic pill. And, although the idea of an electronic pill has been around for decades, researchers never quite brought this technology to reality. That is, until now.

Medimetrics, a Germany-based company developing electronic oral drug delivery, has brought this idea to reality with its IntelliCap technology.

“Our challenge was to construct and deploy a device using advanced, but available, components and production techniques,” says Jeff Shimizu, CTO, Medimetrics in an interview with R&D Magazine. Elements of drug, electronics, wireless communication and micromechanics had to be combined in a way to preserve small size, reliable manufacturing and a safety profile fit for medical use.

“An electronic drug delivery pill presents an entirely new means of intelligent delivery and monitoring,” says Shimizu. And this development opens the door to a wide range of applications which are in the early stages of exploration.

About the IntelliCap technology

The first use for the IntelliCap system has been as an effective delivery tool for targeted modified release formulation development. “This has already enabled more efficient research and development of new pharmaceutical products,” says Shimizu. Future versions of the technology will be customized, aimed at specific disease treatments that at the same time take advantage of monitoring and electronic control functions.

The IntelliCap system is an electronic drug delivery and monitoring device. The technology includes a drug reservoir, delivery pump, electronic microcontroller, wireless communication and sensors.

The delivery device is constructed in a small pill-shaped capsule that is swallowed and passes through the gastro-intestinal tract. While in the body, the capsule takes measurements of the local pH and temperature. This data is reported by wireless RF communication to an external unit and may be monitored at a computer or mobile device.

Additionally, commands may be sent to the capsule while in the body. The measurements allow localization of the IntelliCap capsule which, in turn, is used for accurate delivery of drug at specifically targeted locations in the gastro-intestinal tract. Drug delivery is controlled by the on-board electronics enabling both precise and adaptable delivery patterns that are not possible by other means.

Opening new research opportunities

A recent R&D breakthrough made possible by the IntelliCap system saw the capsule performing in a new way—this time required to operate as a sampling device rather than as a delivery system.

“The capsule first enters the body with its reservoir empty, but as it reaches the small intestine it’s then ‘commanded’ to aspirate a volume of fluid,” says Shimizu. “This operation allows, for the first time, a means of examining the contents of the small intestines in a convenient and non-invasive way.”

It’s known the composition of the microbiota in the gut varies between individuals, and this composition has a relationship to health and disease. These relationships and the opportunities to improve health and/or treat disease by controlling the composition are an active and promising field of research.

Knowing the potential the technology has for this field of research, scientists at Wageningen Univ. saw the opportunity with the IntelliCap technology to characterize the microbiota in the small intestines in a natural and non-invasive way. “Up to now, most of the work in microbiota researcher is conducted by analyzing fecal samples,” says Shimizu. “While this part of the body is easily accessible, analysis of fecal samples will always be incomplete.”

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