Wearable Patch Reader for Peripheral Artery Disease

Abstract The goal of this Phase II SBIR is to convert Profusa s bulky cabled optical reader into a wearable flexible disposable bandage like format that conforms to the foot for continuous monitoring of tissue oxygen levels during revascularization and restenosis in patients with peripheral artery disease PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by CLI and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate monitoring and treatment disease progression can be halted and even reversed but easy to use accurate monitoring products to indicate when a change in therapy is needed do not exist A tissue oxygen monitoring tool that is minimally invasive offers high sensitivity and stability and could give rapid tissue measurements would be ideal for point of care monitoring and remote continuous measurements PROFUSA s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear The development of the flexible patch reader would allow for continuous wireless monitoring giving critical patient data to doctors patients or other caregivers in real time Furthermore this technology has the potential to be transformative not just for PAD but for the broad field of continuous in vivo diagnostics and mobile health monitoring In this Phase II SBIR grant we propose to first convert Profusa s current optical reader into a flexible wearable format i e optical patch reader through component redesign using novel flexible thin film conformal electronics We will then test the redesigned flexible patch reader in vitro Lastly the project will culminate in a clinical study to test safety wearability human factors and in vivo functionality Project Narrative Peripheral arterial disease PAD in which plaque buildup obstructs arteries causing decreased tissue oxygen levels is estimated to affect to million people in the U S creating an annual economic burden of more than $ B Decreased tissue oxygen levels can lead to intermittent claudication or in more advanced cases gangrene and amputation Development of a flexible patch reader as a companion device to Profusa s oxygen sensing technology would allow for continuous wireless monitoring which could help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear