Scientists develop smart pacemaker that dissolves harmlessly in the body when no longer needed

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Scientists develop smart pacemaker that dissolves harmlessly in the body when no longer needed

Last summer, scientists at Northwestern University unveiled the first-ever transient pacemaker — a fully implantable wireless device that dissolves harmlessly in the body when it’s no longer needed .

Now, they’ve introduced a new smart version that’s integrated into a coordinated network of wireless, soft, flexible, wearable sensors and control units placed around the upper body.

Scientists develop smart pacemaker that dissolves harmlessly in the body when no longer needed

The study was published May 27 in the journal Science . The work was led by John A. Rogers, Igor R. Efimov, and Rishi Arora of Northwestern University.

These sensors communicate with each other to continuously monitor various physiological functions of the body, including body temperature, oxygen levels, respiration, physical activity, muscle tone and electrical activity of the heart.

The system then uses algorithms to automatically analyze these combined activities to autonomously detect abnormal heart rhythms and decide when and at what rate to pace the heart.

All this information flows to a smartphone or tablet, so doctors can monitor their patients remotely.

New transient pacemakers and sensor/control networks could be used for patients who need temporary pacing after cardiac surgery or who are waiting for a permanent pacemaker.

The pacemaker wirelessly draws power from a node within the network — a small wireless device that fits softly onto a patient’s chest.

This technology eliminates the need for external hardware, including wires.

To enable the system to “communicate” with the patient, the researchers incorporated a small, wearable haptic feedback device that can be worn anywhere on the body.

When the sensor detects a problem (such as a low battery, an incorrectly positioned device, or a malfunctioning pacemaker), the haptic device vibrates in a specific pattern to alert the wearer and inform them of the problem.

“This marks the first time we’ve paired soft, wearable electronics with a transient electronics platform,” Rogers said. “This approach could transform the way patients receive care, providing multimodal, closed-loop control of fundamental physiological processes — via a wireless network of sensors and stimulators that operate in a way inspired by the complex, biofeedback loops that control behavior within living organisms .”

“For temporary cardiac pacing, the system frees patients from monitoring and stimulation devices that confine them to hospital settings. Instead, patients can recover in the comfort of their own home while maintaining the peace of mind that comes with being monitored remotely by a doctor. It will also reduce the cost of healthcare and free up hospital beds for other patients.”

Efimov said: “In the current situation, a temporary pacemaker requires a wire that is connected to an external generator that stimulates the heart. When the heart regains the proper ability to stimulate itself, the wire has to be pulled out. As you might imagine That way, pulling out the wires that go to the heart is a fairly dramatic process. We decided to approach this from a different angle. We created a pacemaker that simply dissolves and doesn’t need to be removed. This It avoids the dangerous step of unplugging the wires.”

“Current pacemakers are quite intelligent and respond well to the changing needs of patients,” Arora said. “However, a wearable module can do everything a traditional pacemaker does and more. The patient basically wears a small patch on the chest and gets real-time feedback to control the pacemaker. Not only is the pacemaker itself Bioabsorbable, it is also controlled by a soft wearable patch, allowing the pacemaker to respond to usual life activities without the need for implanted sensors.”

Rogers is the Lewis-Simpson and Kimberly-Querey Professor of Materials Science and Engineering, Biomedical Engineering, and Neurosurgery in the McCormick School of Engineering and Northwestern University Feinberg School of Medicine, and the Queret-Simpson Institute for Bioelectronics (QSIB) ) director.

Efimov is the McCormick Professor of Biomedical Engineering and the Feinberg Professor of Medicine (Cardiology). Arora is a Feinberg professor of medicine and co-director of the Arrhythmia Research Center.

Connecting to the “Body Area Network”

A pioneer in bioelectronics, Rogers and researchers in his lab have been developing soft, flexible wireless wearables, as well as bioimplantable electronics, for nearly two decades.

In the new study, Rogers and his collaborators combined and coordinated their bioabsorbable lead-free pacemaker with four different skin interface devices to work together.

The skin-mounted device is soft, elastic, and can be gently peeled off after use without requiring surgical removal. Pacemakers dissolve naturally in the body after a period of use.

This “body area network” includes:

A battery-free, transient bioabsorbable pacemaker for temporarily pacing the heart;
A heart module located in the chest that provides power to the implanted pacemaker and controls stimulation parameters, as well as senses the electrical activity and sounds of the heart;
A hemodynamic module on the forehead for sensing pulse oxygen saturation, tissue oxygen saturation and vascular tone;
A breathing module at the bottom of the throat that monitors coughing and breathing activity;
A multi-haptic feedback module that vibrates and pulses in various patterns to “communicate” with the patient.

“We wanted to demonstrate that it is possible to deploy many different types of devices, each performing basic functions throughout the body in a wirelessly coordinated fashion,” Rogers said.

“Some are sensing. Some are providing electricity. Some are stimulating. Some are providing control signals. But they all work together, exchanging information, making decisions based on algorithms, and responding to changing conditions. The vision of multiple bioelectronic devices talking to each other and performing different functions in different relevant anatomical locations is a frontier area that we will continue to pursue in the future.”

Since Northwestern’s transient pacemaker was first introduced a year ago, researchers have made several improvements to advance the technology.

Whereas the previous device was flexible, the new device is flexible and elastic, allowing it to better adapt to changes in the beating of the heart.

Another new benefit: As the transient pacemaker dissolves slowly and harmlessly, it now releases an anti-inflammatory drug to prevent foreign body reactions.

Perhaps the most impactful advance is the device’s ability to deliver on-demand pacing based on the patient’s needs.

Synchronized with the pacemaker, the chest-mounted cardiac module records ECG in real time to monitor cardiac activity.

In the study, the researchers compared this wireless technology to the gold-standard electrocardiogram and found it to be as accurate and precise as a clinical-grade system.

Efimov explained: “The heart module actually tells the pacemaker to stimulate the heart. If normal activity resumes, then it stops pacing. This is important because if you stimulate the heart when it is not necessary, then you It may induce arrhythmia.”

“The pacing system is fully autonomous,” said Yeon Sik Choi, a postdoctoral researcher in Rogers’ lab and one of the paper’s first authors. “It can automatically detect the problem and apply the treatment. It’s easy and self-contained with minimal external requirements.”

Gentle enough care for newborns

Rogers, Efimov, Arora and their team believe their system is best for the most vulnerable patients.

Each year, about 40,000 babies are born with a hole in the wall that separates the upper chambers of the heart.

About 10,000 of these cases are life-threatening and require immediate surgery. After surgery, 100 percent of babies receive a temporary pacemaker.

“The good news is that this is a temporary situation,” Efimov said. “After about five to seven days, the heart regains its ability to stimulate itself and the pacemaker is no longer needed.The procedure for removing the pacemaker has improved a lot over the years, so the complication rate is low. But we These babies could be freed from wires connected to an external generator, so they wouldn’t need a second surgery.”

Reference

https://www.science.org/doi/10.1126/science.abm1703

Scientists develop smart pacemaker that dissolves harmlessly in the body when no longer needed

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