If regulatory approval goes well, it could be possibly called the future of insulin delivery. On one hand, there's Debiotech (Lausanne, Switzerland) and its expertise in insulin delivery systems and on the other, there's STMicroelectronics' (Geneva, Switzerland) background in developing microfluidic technology.
The result is the Nanopump, which relies on microfluidic MEMS (micro-electro-mechanical system) technology to deliver insulin dosage. Both companies released the first evaluation prototypes of the miniaturized pump.
"The pump uses microfluidics, which is technology dealing with the transmission of movement of a very small liquid through a structure," Mike Markowitz,
technical media relations director of STMicroelectronics, told Medical Device Daily. "In this case, the liquid is insulin."
The tiny device is mounted on a disposable skin patch to provide continuous insulin infusion, enabling substantial advancements in the availability, treatment efficiency and the quality of life of diabetes patients.
"It is less than one-fourth the size of existing insulin-pump devices or "roughly the size of a thumbnail," Markowitz said.
To be more precise, it has a total volume of 65 mm x 38 mm x 11 mm (27 ml), with an insulin reservoir capacity of 4 ml to 6 ml and the permanent part attached.
As a disposable device, manufactured using high-volume semiconductor processing technologies, the MEMS-based Nanopump also is much more affordable, allowing the patient or the health insurance system to avoid the substantial up-front investment typically associated with current pump solutions.
"Because it's a disposable unit, the cost would be significantly less than other forms of insulin delivery," he said. "There is usually a high up-front cost point for other forms of delivery; this device wouldn't have that."
Insulin pump therapy, or continuous subcutaneous insulin infusion (CSII), is an increasingly attractive alternative to individual insulin injections that must be administered several times a day. With CSII, the patient is connected to a programmable pump including a storage reservoir, from which insulin is infused into the tissue under the skin throughout the day according to specific needs as programmed by the patient. Microfluidic technology is said to provide better control of the administered insulin doses, more closely mimicking the natural secretion of insulin from the pancreas, while detecting potential malfunctions of the pump to further protect patients.
Dosing precision is a critical factor in treatment efficacy and contributes to reducing adverse long-term consequences. The Nanopump is able to control delivery at the nanoliter level, very close to the physiological delivery of insulin. The device prevents over-dosing and detects under-delivery, occlusion, air bubbles and other potential malfunctions in the pump to further protect patients.
But don't expect to see this device available anytime soon, the company says.
"We're probably looking at a stage of two to three years before getting regulatory approval and putting this in the hands of patients," Markowitz said. "One of the things we have to be clear on is that we're not yet at the point where we can sell this to the consumer."
The market for insulin pump therapy is growing rapidly: according to HSBC, the worldwide market is expected to grow from $800 million in 2004 to $1.6 billion by next year.
Almost 250 million people are affected by diabetes worldwide and the number is expected to grow over the next decade due to population growth, aging and lifestyle. Without proper treatment, diabetes can lead to cardiovascular disease, kidney failure, blindness, nerve damage and ultimately death. Diabetes is a leading cause of death in most developed countries.
"The success of the initial prototype tests has moved the revolutionary insulin Nanopump a step closer to market availability," said Benedetto Vigna, group vice president and general manager of ST's MEMS and Healthcare, RF Transceivers and Sensors Division. "Working with our key partner Debiotech, we are readying a tiny piece of silicon that can make a huge difference to millions of diabetes patients around the world."
Debiotech specializes in the development of devices in the field of implantable and external drug delivery systems, using micromechanics, nanotechnologies and MEMS, for the treatment of severe diseases such as diabetes, renal failure, cardiovascular diseases and cancer, as well as novel technologies for the delivery of vaccines, diagnostic and imaging devices.
STMicroelectronics develops semiconductor solutions across the spectrum of microelectronics applications.