At Tillges Certified Orthotic Prosthetic Inc. in Maplewood, Minn., the practitioners are highly experienced at wound care management. However, without a way to accurately measure the amount of pressure placed on a wound, it can be difficult to successfully close wounds, especially for patients with decreased sensitivity caused by peripheral artery disease or other types of nerve damage.

“We really didn’t have a tool to determine if we were taking enough pressure off the wound site to speed healing,” Mike Tillges, CPO, a practitioner at Tillges Certified Orthotic Prosthetic Inc. (TCOP), told O&P Business News. “So we took the next step and developed a clinical tool to determine if we are doing our job correctly and the orthosis is fitting correctly, taking pressure off the wound area.”

To do this, Mike Tillges, along with Bob Tillges, CPO, FAAOP, the owner and president of TCOP, and Steve Tillges, CPO, launched Tillges Technologies LLC and created the PressureGuardian.

PressureGuardian

The PressureGuardian, which has been in development for more than 2 years, is a wireless sensor that can detect pressures being placed on an ulcer. The sensor, which is placed under the patient’s wound site, is connected to a WiFi module battery. The entire device attaches to an orthotic or prosthetic device, and the sensor wirelessly transmits data to an Apple iOS device, such as an iPhone or iPad.

Left to right: Mike Tillges, CPO; Bob Tillges, CPO, FAAOP and Steve Tillges, CPO, creators of the PressureGuardian. Images: Tillges Technologies

“With the WiFi capabilities, we’ve created an application strictly for Apple at this time with future plans for Android capability,” Mike Tillges said. “The unit will talk via WiFi to the application, which can be used on any Apple device. The app then records the instantaneous pressures, graphs the pressures and gives a digital readout along with an analog readout.”

The device, which is currently intended for use in a clinical setting, can read pressures for 20-second intervals as the patient is ambulating.

The wireless sensor is attached to an orthosis or prosthesis, and sends data to an Apple iOS device.

“We can record pressures during a gait cycle and see the average maximum and minimum pressures for that 20-second gait cycle,” Mike Tillges said.

The last component of the device is the patient report, which can be created within the app and stores all pertinent patient information.

“We have the ability to enter different patient information, such as the size of the ulcer, what type of brace we’ve put the patient in, and also what type of boot we’ve created for the patient,” Mike Tillges said. “Then that information gets put into a PDF report along with the pressure readings, graph of the pressure readings and a photo of the wound. The patient report can be printed, emailed or saved for future reference.”

According to Tillges, the technology is compliant with all HIPAA guidelines, so all patient information will be protected if a report is emailed between clinicians in order to better patient care.

Benefits

Information collected by the 
PressureGuardian can be used to adjust orthotic and prosthetic devices in order to offload pressures being placed on the wound or inside a prosthetic socket. This can potentially accelerate the healing process for wounds. The patient data also provides evidence-based feedback about patient compliance and wound management.

The PressureGuardian was developed under the guidance of the Institute for Healthcare Improvement Triple Aim initiative, which seeks to improve the national standards of health care.

“It is a national act to better the care of individuals, and there are three components: improve the patient experience of care, improve the health of populations and reduce the per capita cost of health care,” Mike Tillges said. “And we feel that this product meets all three of those 
initiatives.”

The device can be worn with most types of footwear, including custom orthoses and prostheses. The PressureGuardian currently can only monitor a single wound site, but Tillges Technologies is working on creating a four-lead sensor in order to monitor multiple sites.

“There is also an accelerometer built into the unit, which we haven’t implemented yet,” Mike Tillges said. “So once we have future development of the application, we’ll have those new changes built into it.”

Tillges Technologies held a soft launch of the device in February and will fully launch the product in September at the American Orthotic and Prosthetic Association O&P World Congress in Orlando.

“It is a device that really provides great data, ensures that our orthoses are properly crafted, and we get offloading second to none,” Bob Tillges said. “We have better fits, function and outcome. It’s all greatly improved, and we become better practitioners as we address these conditions by utilizing this technology.”

Currently, the use of the device is not covered by insurance, but according to Tillges, the cost of the device is worth the benefits and potential cost savings.

“The biggest thing is cost-savings. It is a little more work upfront, but we know what our results are and that we reduce the pressures,” Bob Tillges said. “Currently, we know that we are reducing doctor visits, healing wounds faster and reducing surgeries and possible amputations.”— by Megan Gilbride