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Blood pressure monitoring goes wireless

 

It’s difficult to imagine a sensor a little larger than a grain of rice improving someone’s life, let alone possibly saving it, but those goals are the driving forces behind the wireless blood pressure monitoring device being developed by Bradley University and two Peoria-area businesses.

Joining Bradley’s Department of Electrical and Computer Engineering professor Dr. Prasad Shastry in a three-way agreement to collaboratively develop the device are East Peoria-based companies Endotronix Inc. and Validus LLC. A graduate of the Peoria NEXT Innovation Center, Endotronix focuses on developing technologies to improve cardiovascular disease with its current focus being strictly on control of blood pressures. Validus LLC is an advanced electronic engineering company focusing on emerging technologies.

“This is a great technology that’s going to have a huge impact on doctors,” says Bradley alumnus David Paul, who is president and
chief executive officer of Validus.

Dr. Prasad Shastry (left), electrical and computer engineering professor, works on research for the sensor component of the wireless blood pressure monitoring device with Divya Gamini. After she completed her research work at Bradley and earned her masterís degree, Gamini continued to work on the monitoring device with Validus LLC in East Peoria.

“Uncontrolled high blood pressure is a major risk factor for all cardiovascular diseases. If you can control blood pressure, you can dramatically reduce the risk of stroke and heart attack,” Dr. Harry Rowland, vice president of engineering and co-founder of Endotronix, relates. “Patients who have heart failure and kidney failure are really in critical need of blood pressure monitoring to keep them out of the hospital. By monitoring them more routinely when they are out of the hospital, we would be able to prevent those diseases from progressing and some of these acute events from actually happening.”

Upon completion, the two-component device will consist of the biocompatible sensor—a pressure-sensitive microelectromechanical system (MEMS) capacitor with a chip inductor/radiator—that will be implanted internally in the wall of a cardiac patient’s major artery and an external, handheld reader that patients hold in front of their body. The internal sensor sends a radio frequency signal that indicates real-time blood pressure data to the external reader. The external device will then wirelessly transmit
the data via the telephone or the Internet to the doctor or hospital. Thus, the device will enable the doctor to monitor the blood pressure after the patient goes home.

According to Rowland, “We will be working with (severe) patients who will already be getting a surgical intervention and an implantable device anyway. The sensor will actually “piggyback” on this existing medical device, therefore it will not be taking up any additional space in the artery. “The physician who is trained in using the medical device just uses it as he normally would and that ends up implanting the sensor and securing it in place inside an artery.”

And, what happens if the implanted device goes bad? “It just sits there because there’s nothing active in the device,” Rowland comments.

Dr. Anthony Nunez, co-founder of Endotronix and a cardiothoracic surgeon previously based in Peoria who now works for the Hershey Medical Center in Pennsylvania, initially brainstormed ideas with Shastry in 2006 for developing a unit for severe cardiac patients. Nunez wanted a unit that could measure the pressure in the arteries directly without connecting any wires because the blood pressure cuff is not a true indicator of the pressures inside, Shastry relates.

In order to develop the sensor, Endotronix acquired licenses to use two inventions patented by the Glenn Research Center of the National Aeronautics and Space Administration (NASA) in Cleveland. In order to license the patents, however, the group had to convince NASA that their project was sound.

“Our contribution from Bradley has been all the foundational work for this project, and that helped them get the licenses from NASA and hence obtain the first round of venture capital funding,” says Shastry. He collaborated on the project with Divya Gamini, a graduate student at the time whose position was funded through a grant from Endotronix. Through Shastry and Gamini’s work, NASA deemed the research sound. Other graduate students who assisted in the research included Suresh Sundaram and Raghu Kancharla.

Working on the three-way agreement with Bradley University has been a positive experience, according to David Paul (seated), president and chief executive officer of Validus LLC, and Dr. Harry Rowland, co-founder and vice president of engineering for Endotronix Inc. Originally, Endotronix was going to utilize a company based in Silicon Valley, but Dr. Prasad Shastry encouraged Dr. Rowland to work with the local company.

Since acquiring the licenses, Endotronix has continued to innovate and develop technology to commercialize wireless blood pressure monitoring.

After doing the preliminary work, Shastry says the University’s role in the product’s development ended aside from Validus and Endotronix using Bradley’s Advanced Microwave Engineering Laboratory facilities for testing. “The University’s job is to innovate; to come up with new ideas, and then educate and train students. Once we come up with new ideas through research, then that has to be converted into a commercial product by a company.”

The three-way agreement has been a positive experience for all three entities involved.

“It helps us leverage all the resources in the area,” Rowland remarks. “We’re much stronger if we work together.”

One of the positives of this three-way agreement includes the training the students received in biomedical research, Shastry says.

“Working on this project for my master’s degree gave me really good exposure,” Gamini says. “I can understand more what is happening. Of course, working with Dr. Shastry is really a pleasure. He goes out of his way to help a student grow from within.”

Gamini’s research was a bridge to her current job developing the next-generation sensor at Validus. Gamini completed her research at Bradley in December 2008 and started work with Validus after graduation. Gamini and Shastry presented the research at two leading international microwave conferences: the IEEE International Microwave Symposium in Boston, Massachusetts, in June 2009, and the European Microwave Conference in Rome, Italy, in September 2009.

As an employee of Validus, Gamini finds herself back in Bradley’s Advanced Microwave Engineering lab working on the device.

"In the future, the focus of a lot of electronics will be how to help the human body."

Dr. Prasad Shastry, electrical and computer engineering professor

The equipment in Bradley’s Advanced Microwave Engineering lab is vital to the development of the product, Paul comments. Without those tools, Paul relates they might have to travel a further distance to conduct lab work.

Now that Bradley’s contribution is finished, Validus is further developing the product. Validus hopes to finalize sensor design in early 2010, making the reader more compact.

Animal testing has begun on the product. “They were very happy that they could receive a signal from the sensor inside the body of the animal,” Shastry states.

The device will undergo several months or years of animal studies before it is deemed to be performing properly and proven to be safe and effective, according to Rowland. “Once we hit that milestone, we’ll go through investigations and clearances.” He estimates a couple of years of strictly controlled safety studies in humans will be needed before it is available in the market.

It has to go through all of the validation and Food and Drug Administration testing before it is ready, Paul adds. “It’s actually a simple device, but designing it is a challenge.”

“It’s going to be a long time before we’re ready for it, but it really does have the potential to improve quality of life,” Rowland adds.

Delving into this type of research is also a positive for the University, Endotronix, and Validus. Shastry says, “In the future, the focus of a lot of electronics will be how to help the human body.”