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The V-Needle: A Failsafe Protection against Needle Dislodgement during Dialysis

V 形针：防止透析期间针移位的故障安全保护

基本信息

批准号：
9250771
负责人：
PATRICK J ROUSCHE
金额：
$ 83.88万
依托单位：
HEMOTEK
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-20 至 2018-09-24
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9250771
关键词：
3D Print Adopted Algorithms Animal Testing Animals Back Benign Blood flow Body Size California Canis familiaris Catalogs Cessation of life Clinic Clinical Congresses Custom Data Devices Dialysis patients Dialysis procedure Documentation End stage renal failure Engineering Event Excision Filtration Food and Drug Administration Device Approval Fright Guidelines Hemodialysis Hemorrhage Hemorrhagic Shock Home environment Human Incidence Industry Injury International Interview Kidney Legal patent Medical Medical Device Medicine Mind Needles Nurses Operating System Output Patient Care Patient-Focused Outcomes Patients Performance Phase Printing Procedures Production Provider Recording of previous events Risk Management Safety San Francisco Savings Skin Small Business Innovation Research Grant System Testing Training Translating Universities Venous Work arm biomaterial compatibility blood pump cost design experience fluid flow improved meetings miniaturize novel patient safety peace pressure product development prototype public health relevance research and development standard of care verification and validation

项目摘要

DESCRIPTION (provided by applicant): 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.