Veterans Affairs

FlexSTIM implantable muscle stimulator for preventing pressure ulcers

Addresses hard to treat wounds commonly developed from prolonged bed rest

Medical & Biotechnology

This novel medical device could be the next product your company launches. The Department of Veterans Affairs is making its patent-pending FlexSTIM available for commercialization.

Rendering of the flexSTIM implantable muscle stimulator. Credit: Case Western Reserve University School of Medicine

A spinal cord injury (SCI) can leave an individual with limited or no mobility resulting in a need for extensive therapy and interventions for musculoskeletal health.

For example, as a consequence of impaired mobility after an SCI, an individual may acquire pressure ulcers (PU) and deep tissue injury (DTI) from sitting or lying in place. Electrical stimulation applied to the surface of the person’s skin can help but often requires an excessive charge and may fail to penetrate the surface tissue enough to stimulate deep tissue to reduce PUs and DTIs. Further, repeated application of electrodes to the same surface of the skin can cause damage.

To address the above problems, VA researchers have developed a flexible implantable tissue stimulator known as flexSTIM. The tiny device can be placed through a one-inch incision and provide defined electrical stimulation to exercise regions of impaired or paralyzed muscle tissue. In one example, the device can be placed in gluteal muscle tissue to improve the health of the seating surface by reducing regional interface pressures (i.e. static sitting pressures in the sacro-ischial region) and increasing blood flow. By mimicking regular weight-shifting and consequently increasing muscle bulk, the stimulation will improve muscle health, treat existing PUs and help prevent future PUs and DTIs.

Designed from a liquid crystal polymer, the device can be safe for MRI procedures. The flexible nature allows it to conform to various shapes and positions without causing rigid points. The device is battery driven and programmable. Leveraging the body’s own nervous system, the electrodes can be placed next to nerves and thus a lower amount of power can be used to stimulate the nerve extending the life battery life of the unit.

Current commercially available stimulators require major surgery and must be located in body regions with ample soft-tissue cushioning, such as the abdomen. Implanting flexSTIM will be an outpatient procedure and only require local anesthesia.

A limited human trial was conducted on a related device.

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