Uplift

What it does

Due to inadequate reflexes, dysautonomia patients experience abdominal blood pooling, causing them to feel dizzy or faint. Uplift provides extracorporeal pressure to promote blood flow back to the heart, improve perfusion to vital organs and prevent syncope.

Your inspiration

In 2021, a cardiologist contacted Duke Biomedical Engineering to find a solution for a severely symptomatic dysautonomia patient for whom all available treatment options had failed and who was about to be put in palliative care. Despite its disabling symptoms that affect millions of people worldwide, some forms of dysautonomia such as POTS are vastly underdiagnosed diseases that have only garnered attention in recent years. The condition is still poorly understood, and treatments are often inadequate. Our team spans across multiple disciplines to investigate and develop novel compression solutions for dysautonomia patients.

How it works

Following stakeholder feedback and several iterations of prototypes, we have developed a low-profile, adjustable abdominal compression belt that relies on a cinching mechanism (dis)engageable via a rotational knob. When donning the device, the cinching mechanism is disengaged, and the belt is fastened around the waist via Velcro straps. Then, the rotational knob is used to tighten the lacing of the cinching apparatus and apply circumferential pressure as needed by the patient to relieve symptoms. An internal air bladder and pressure gauge are used to inform the user on how much pressure is applied to the abdomen and ensure pressures stay within the therapeutic range. A pocket at the front of the belt allows for the insertion of a small foam pad. When engaging the cinching mechanism, this pad will produce a local pressure point and engage additional physical countermeasures to relieve symptoms. This might be needed by patients with increased symptom severity.

Design process

A first iteration prototype of adjustable abdominal compression was developed in Fall 2021. This first iteration consisted of a belt with an integrated air bladder that can be inflated to provide circumferential compression. Several dysautonomia patients noticed symptom improvements with this device, however, a wide-reaching survey study and stakeholder interviews showed that there were unmet patient needs in areas of comfort and concealability. This led us to investigate more targeted compression as this might be more concealable. A second prototype used a piston which could be regulated via an air compression tank or by adjusting the extrusion length to apply different amounts of localized pressure. A first IRB-approved study in healthy volunteers showed that while local pressure does affect relevant vital signs, global compression is more effective overall. Taking these findings into consideration, a third, more concealable prototype was developed that provides broad compression via cinching. It also contains the option for local compression to investigate whether a combination of different pressures might increase symptom relief. All three prototypes will be tested in dysautonomia patients this Fall and the designs will be further optimized according to the results.

How it is different

To mitigate dysautonomia symptoms, abdominal compression of 30-40 mmHg is needed. However, commercially available shapewear often used by patients only provides around 10 mmHg and does not offer adequate support to counteract significant abdominal venous pooling. Uplift applies sustained targeted therapeutic pressure and enables user-controlled pressure modulation so that different symptom severities can be considered. Additionally, traditional abdominal binders provide constant compression when worn, only ceasing when doffing the device. This can be uncomfortable and especially bothersome to the many patients with comorbid gastro-intestinal issues. Thus, Uplift is designed to be dis-engageable even when worn. Finally, patients have reported difficulties with the donning and doffing of existing medical compression. Uplift addresses this issue by using simple Velcro straps and applying pressure only after the device has been donned.

Future plans

Following promising results of a study in healthy volunteers, we will test the devices in dysautonomia patients in the coming months to investigate efficacy of different compression mechanisms for a range of body habitus and symptom severity. The prototype design will be further refined based on the clinical trial and stakeholder feedback. We will also consult with textile experts to maximize style and breathability while ensuring the entire device can be machine-washed. Ultimately, we intend to register Uplift as a Class 1 medical device with the FDA. Commercializing this technology will require standardized good manufacturing practices.

Awards

Uplift was rated as one of the university's top projects by the Duke Design Health leadership in Spring 2023. We have also received Student Startup Funding from our university.