On average, more than 1,800,000 sessions of hemodialysis are performed each week in the U.S. by more than 600,000 end stage renal disease (ESRD) patients. A grave danger to any of these patients is Venous Needle Dislodgement (VND), a catastrophic and potentially deadly unintended removal of the needle pumping blood back into the body. Incident rate estimates vary widely, but in any given week, possibly more than 200 hemodialysis patients will suffer an incidence of VND. VND is a constant and ever-present danger that looms over each and every one of the ~100,000,000 hemodialysis sessions performed each year in the US alone. The entire industry is in dire need of an inexpensive, practical and widely applicable solution that can easily insure patient safety during hemodialysis. To fill this need, Hemotek has invented the V-Needle, a disposable failsafe dialysis safety product that will protect hemodialysis patients from deadly bleed-out during incidences of VND. The V-Needle will be a low-cost, easy-to-manufacture, and simple-to-operate system that will protect patients from the devastating effects of VND. In a Phase I SBIR study we conclusively showed the engineering characterizations that outlined the feasibility of manufacturing such a device. In this Phase II project, we now optimize that design and prepare the device for submission to the FDA for approval to market in the US: Specific-aim #1: Meet with the FDA to finalize a regulatory strategy and Begin documentation: 1.1) Prepare a pre-meeting report and Strategize with the FDA to solicit a regulatory plan 1.2) Begin FDA-mandated User Needs, Design Inputs/Output files for the Design History File 1.3) Conduct and document a Risk Management Strategy Specific-aim #2: Develop an optimized, alpha design for the V-Needle: 2.1) Decrease design complexity by reducing the number of moldable components required 2.2) Implement the V-Needle with an `arming' mechanism that will simplify initial insertion 2.3) Miniaturize the design so that the new product is within 25% of current needle-body sizes Specific-aim #3: Characterize and Assess the alpha V-Needle, iterate to beta: 3.1) Determine final V-Needle component materials and Establish biocompatibility 3.2) Quantify closing force, backpressure and flow using a custom benchtop flow apparatus 3.3) Establish human factors and other engineering criteria so the optimized V-Needle meets intended user needs (via clinical staff/patient interviews) 3.4) Demonstrate that the alpha V-Needle protects against dislodgement in animals (dog) Specific-aim #4 Determine beta V-Needle safety and efficacy, translate to pre-production: 4.1) Assess clinical implementation via simulated use testing on training dummies 4.2) Demonstrate that the beta V-Needle protects against dislodgement in animals (dog) Specific-aim #5 Prepare and Submit a finalized 510(K) application to the FDA: 5.1) Collaborate with FDA consultants, The Experien Group, to prepare/submit a 510(K) The internationally patent-pending V-Needle has the potential to save lives, improve patient care and provide priceless peace of mind for hemodialysis patients and care providers. In Phase II, Hemotek will optimize our working prototype into a robust, commercially viable product. Phase II R&D efforts will center on product verification and validation, including biocompatibility testing, functionality testing, animal testing and simulated use testing. In addition all relevant FDA-required documentation will be performed to enable an efficient FDA review. At the end of Phase II Hemotek will have a full working and validated version of the V-Needle ready for 510(k) submission to the FDA. Rendition of a pre-production prototype.
In the US, there are more than 1.8 million sessions of hemodialysis every week. A grave danger faced by every dialysis patient is venous needle dislodgement (VND), the inadvertent disconnection of the line pumping blood back into the body after filtration. In this Phase II SBIR application, Hemotek proposes to optimize a working design of a novel hemodialysis needle, the V-Needle. The V-Needle will automatically detect VND and work to immediately shut off the blood flow, saving lives and increasing dialysis safety. The work will be done according to FDA guidelines and an application for FDA approval of the device will be submitted upon conclusion of the Phase II activities.
