20 February 2012

Nurse-on-a-chip

Chip implant for injection tested on humans for the first time

Leonid Popov, Membrane,
based on MIT materials (Successful human tests for first wirelessly controlled drug-delivery chip)
and BBC ('Pharmacy on a chip' gets closer).

The Americans conducted successful clinical tests of a device that injects the necessary drugs into the patient's body according to a pre-prepared program or by a radio signal from outside.

 
Experimental "wireless device with a microchip for drug delivery" (Wireless Microchip Drug Delivery Device) –
the brainchild of a group of scientists from the Massachusetts Institute of Technology and the MicroCHIPS company they created.

The implant body is made of biocompatible materials. Its dimensions are 3x5x1 centimeters. The device, programmed and filled with medications, is implanted under the skin of the owner in the selected area (in these tests – in the waist area) under local anesthesia. The operation takes less than 30 minutes.

In terms of dimensions, the device is not much larger than a flash drive. There should be no particular discomfort from its presence in the patient's body (photo by MicroCHIPS).

In the center of the device is the actual chip with medicines. They are placed in 20 microscopic ampoules covered with a very thin membrane of platinum and titanium. Their absolute tightness guarantees the safety of even a relatively unstable drug for a long time.

When the electronics supply a weak current to the ampoules, their metal wall melts in just 25 microseconds and the medicine is released into the body. It is immediately absorbed by the capillaries surrounding the implant.

There are several advantages of such a technology for the supply of medicines.

Firstly, the patient does not need to visit a doctor or nurse for a certain time, or do subcutaneous injections himself. And this is important if the course of treatment involves taking the drug daily or, say, every other day.

Moreover, 20 doses is just the beginning, scientists are already working on a version of the device that will contain 400 doses. They should be enough for more than a year even with daily operation, and with a more rare "schedule" – and for several years.

Secondly, the chip will not miss the injection due to forgetfulness or lack of time.

Thirdly, the chip gives out a very precisely dosed portion of the drug every time, more precisely than with any syringe.

Fourth, the chip can contain several different drugs and release them in a complex sequence, either according to a pre-made plan, or even by commands from outside.

 
Simplified operation diagram of the device (MicroCHIPS illustration).

"You can literally get an entire pharmacy on a chip," says Robert Langer, one of the authors of the project, winner of the Millennium Technology Prize 2008. "It becomes possible to remotely control the delivery of medicines, you can make a pulsating injection, it is feasible to supply several drugs to the patient."

The implant communicates with the outside world via a two-way radio channel on the frequency of the Medical Implant Communication Service (MICS) standard. The current version is triggered at a distance of several centimeters from the transmitter, but the creators of the device plan to expand this range.

The transmitter itself, "talking" with the implanted chip, is connected to a computer. The doctor can remotely program the operation of the implant, change the treatment plan right on the go, as well as monitor the completion of the task.

 
The main inventors of the chip are Professors Michael Cima (left) and Robert Langer –
They work at the David Koch Cancer Research Institute (KI) of the Massachusetts Institute of Technology.
It is not surprising that they expect their invention to be successful in this field of medicine as well
(photo M. Scott Brauer/ MIT).

The first clinical trials of the device started in Denmark in January 2011. The devices were implanted in eight women aged 65 to 70 years who suffered from osteoporosis. Their MicroCHIPS implants contained, respectively, the hormone teriparatide, a drug needed to counteract bone loss.

The devices were programmed to release up to 20 doses of the drug, one per day. Scientists tracked the pharmacokinetics of the substance, showing that it is more stable and uniform than in the case of ordinary daily injections (punctuality of electronics affected).

Pharmacodynamics was also evaluated – the actual effect of the drug on the protection of bones. Qualitatively and quantitatively, it turned out to be identical to traditional subcutaneous injections of teriparatide.

Only one small moment slightly overshadowed this success – one of the eight devices failed (it's hard to blame the developers for this – after all, we have only experimental copies of the new technology in front of us). But the other seven devices coped with the task perfectly.

 
The device can be implanted in various places. But the abdominal area is preferable.
Tests have shown that the device works normally in contact with body tissues.
The large image clearly shows the chip embedded in the implant with 20 microampules
(photographs by MicroCHIPS, M. Scott Brauer/MIT).

MicroCHIPS devices remained in the patients' body for four months. The doctors did not detect any adverse reactions either to the implant or to the drug produced by it.

The subjects themselves noted that the MicroCHIPS device did not affect their quality of life, moreover, they often forgot about it altogether. Details of these trials can be found in an article in Science Translational Medicine (Robert Farra et al., First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip).

Let's add a few words about the history of this development. The idea of an implant chip for programmed drug release came to Langer and his colleague Michael Sima about 15 years ago. They began developing the device by collaborating with John Santini, then still a student.

Ten years ago, this work resulted in the construction of early prototypes of MicroCHIPS tested on animals, as well as the opening of the company of the same name, whose management included Sima and Langer. Now scientists have reached the testing of the device on patients.

 
Michael and Robert constantly remind the main motive of the whole project – strict adherence to the drug administration regime.
Many patients find it difficult to adhere to it on their own,
but the implementation of such a plan is important for the success of therapy
(photo M. Scott Brauer/ MIT).

In parallel, the authors of the device have developed a similar implant that controls the level of glucose in the blood.

In the future, such chips can be combined in one case. Then the implanted device will be able to change the drug release program itself, depending on the condition of the ward.

According to the creators of the MicroCHIPS implant, it should help us enter a new era of telemedicine. "At the moment, doctors have used this implant to treat osteoporosis," Langer explains, "but there are many other possible applications: vaccinations, treatment of multiple sclerosis and cancer, suppression of chronic pain."

In the future, Robert's team plans to build new models and further tests on humans. The release of the serial version of the device on the market is expected in five years.

Portal "Eternal youth" http://vechnayamolodost.ru
20.02.2012

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