Alfred Strickholm - US grants

DESCRIPTION (Adapted from the applicant's abstract): The hypothesis here is that the difficulties in recording from small cells can be mitigated by using the research advances obtained with the metallic polymers of pyrrole and thiophene in micro-electrodes. The overall research objective is to technically develop micro-electrodes capable of recording from small cells with biosensors for potential and functional molecules. Intracellular recording from small cells below 10-15 um diameter becomes problematic because rapid diffusional exchange occurs between the soluble cytoplasmic components and the saline within the inserted micro-electrode. Similarly, a membrane injury and cytoplasm leakage site is produced upon micro-electrode entry due to the electrode glass being wettable and not sealing to the membrane lipid. The hypothesis here is that these two technical problems can be solved by: 1) replacing the saline within the micro-electrode with a conducting polymer which thus eliminates the electrode saline to cytoplasm diffusional exchange, and 2) having the micro-electrode shank lipophilic so that a tight electrode to lipid membrane seal is made upon electrode insertion. These technical changes should preserve the integrity of cytoplasm with micro-electrode penetration and recordings could last hours instead of briefly. These technical studies will use different polymers at the micro-electrode tip for the desired biosensor. The initial polymer utilized will have a defined stable interfacial voltage to record membrane potential. Other polymer interfaces will be formed to measure salient ions, and biochemicals involved in cellular metabolism, in particular those of catecholamines and second messenger functioning. The existing limitations on micro-electrode technology has directed much research effort to the large cell diameter population, but the need for techniques to examine small cells is ever present. The whole cell patch clamp has been useful here; however, cytoplasmic washout is a problem, and the literature utilizing micro-electrodes for small cell recording is scarce. The need for this technology is thus pressing and should contribute to new advances in cellular physiology.

DESCRIPTION (provided by applicant): Phase I studies will investigate the safety and effectiveness of a novel, easy to use, non-invasive device, which mitigates erectile dysfunction (ED). This device, the Erectile Prosthetic Support (EPS) (U.S. Patent 6251067), utilizes a specially engineered elastic band, and a back supporting plate. The elastic band, which when wrapped around the penis, provides uniform light compression and support, to hold a flaccid penis, and creates a comfortable elastic cylindrical tube of sufficient rigidity to permit intromission. Pilot and engineering studies indicate potential effectiveness of the EPS device for the general ED population, which presents an intimate, psychologically debilitating, and lasting challenge to male sufferers and their partners. Estimates of ED in the U.S., indicate 600,000 new male cases appear every year, and the total ED population approaches 30 million men with 20 million affected female partners (1,2). Existing approaches to mitigate ED include but are not limited to penile implants, pharmacological injections or inserts, and prescriptive medicines. These have had limited success, are invasive, expensive, and/or cumbersome to use. Phase I will utilize a series of in-clinical and laboratory studies to determine the safety and effectiveness of the EPS to provide penile support to permit natural intromission for a range of ED sufferers including men no longer able to produce or maintain an erection. Studies will be on a demographically representative sample of men with varied degrees of ED, from mild to severe. Similarly, clinical trials (in-home), with monogamous, married, living together, demographically representative couples, proportionately involving men with varied ED, will be performed to determine the EPS device effectiveness and safety. The studies will provide design information for the manufacture of an optimized EPS device and for Phase II studies suitable on wider population groups. The device's benefits, and a low projected cost, will provide an effective alternative solution for those who suffer from this dysfunction, and improve the quality of life and relations, for a growing group of aging men and their partners.