Epic Medical Inc. — Department of Health and Human Services SBIR Phase II: 101

Description

DESCRIPTION provided by applicant In the United States over deep brain stimulation DBS devices have been implanted to date for treatment of basic tremor Parkinsonandapos s disease and dystonia and clinical trials are underway to evaluate indications for chronic pain severe depression migraines and dementia DBS devices belong to a class of devices called implantable electrical stimulators and close to Million of these devices are implanted annually These devices use electrodes in contact with tissue to deliver electrical pulses to targeted cells to elicit specific therapeutic responses Devices must be replaced as batteries wear down thus improvements in device efficiency will extend device lifetime and reduce the number of replacement surgeries While effective in many cases DBS shows limited effectiveness in others and also has side effects Preclinical studies predict that DBS arrays comprised of many densely packed small electrodes can precisely target brain stem region to improve therapy In general the neuromodulation industry has been evolving towards smaller less invasive electrodes Thus there are strong clinical engineering and power motivations for moving towards smaller electrodes However current electrode materials do not support small sizes without severely restricting the stimulus output Hence an improved electrode material will benefit present and future DBS systems Platinum Group Coatings LLC has developed a cost effective and materials efficient process for applying an ultra low impedance platinum iridium alloy coating onto the contacts of DBS stimulator electrodes If successful this coating will enable next generation stimulation devices by allowing for significantly smaller electrodes to provide the same or enhanced performance Additionally this process will enable microfabricated leads on flex circuit substrates This phase II research will seek to scale our deposition process without jeopardizing coating quality or performance while verifying the long term recording and stimulation performance of the coatings in vivo PUBLIC HEALTH RELEVANCE Deep Brain Stimulators belong to a class of medical devices called implantable electrical stimulators Close to Million of these devices are implanted annually These devices use electrodes in contact with tissue to deliver electrical pulses to targeted cells to elicit specific therapeutic responses Improved electrode materials are proposed that will enable a new generation of implant designs with advanced features which promise less invasive designs and better patient outcomes