“Perfect” Non Stick Aqueous Hydrogel Discovered for Urological Catheters and Stents
According to some sources, catheter and stent manufacturers are crying out for the perfect material to stop devices sticking to (human tissue). Existing technologies and materials are cumbersome, some urological sources say, and coatings are expensive and involve extra manufacturing steps. CEO and founder of Q Urological, Scott Epstein, claims to have developed the “perfect” material — a non-stick aqueous hydrogel biomaterial — and has a patented processing method to boot.
USA-based Q Urological Corporation, has developed a patented manufacturing process which produces a family of very high aqueous content, 100% all hydrogel catheters and stents. The products are made from the company’s trademarked “nothing sticks to it” structural hydrogel bio-material pAguamedicina.
Q Urological has received FDA approval for its pAguamedicina Pediatric Ureteral Stent, and is working to obtain FDA clearance for additional upper and lower urinary drainage products in adults.
Devices comprised of pAguamedicina biomaterial consist of mostly water when fully hydrated with normal saline closely emulating body fluids and mimicking human tissue.
More importantly, devices made from the highly saturated material with less than 10% solids, exhibit significant mechanical characteristics. For example a 5F catheter with a 0.030 inch (0.762 mm) lumen can be stretched 300% with out failure. Additionally, significantly reduced friction can be expected contributing to lubricous outside and inside surfaces which aide in delivery, and, in general — combined with the very soft nature of the device — provide a very plausible atraumatic implant.
Q Urological pAguamedicina devices are not coatings. The catheter or stent is comprised totally of saturated hydrogel and in that manner there is no coating to erode, or become void of solution. And while hydrophilic coatings are widely used, according to Scott Epstein, the CEO and founder of the company, they are typically expensive and can be unreliable.
Q Urological has what the company calls “antifouling” technology, whereby “nothing sticks to it”. According to Scott, this provides “extremely bio-compatible medical devices that continue to maintain an aqueous configuration.
Scott believes that, while almost all peer reviewed sources in the urology industry literature suggests that “the ideal material has yet to be implemented”, pAguamedicina devices will change that premise, addressing bio-film formation, contributing to (1) reduction of ureteral stent encrustation and (2) urethral catheter and stent (infection).
Pursuing these claims Q Urological Corporation will focus on product performance not addressed within the scope of typical 510k approvals. Specifically, diminished bio-films on implanted ureteral and urethral stent and catheters. And while FDA guidelines for product approvals associated with ASTM F1828 and F623 procedures do not address bio-film, pain and discomfort complications widely exhibited by predicate devices, many of which received FDA approvals by conducting in-vitro testing in water rather than human urine, Q Urological feels their all 100% hydrogel pAguamedicina catheter and stent technology which was tested in human urine will exhibit significantly better performance than predicate product.
Thereafter, there are plans to focus this technology on vascular applications focusing the same “antifouling” properties that keep bio-films from adhering, it is anticipated a diminished likelihood of red blood cells attaching to a device in-vitro can be expected. Similarly devices exhibiting reduced boundary layer friction and better fluid dynamic properties would be very beneficial.