Resonance Driven Vascular Entry Needle to Reduce Insertion Forces

DESCRIPTION (provided by applicant): In this Phase I NIH SBIR, Piezo Resonance Innovations will demonstrate feasibility of the Resonance Driven Vascular Entry Needle (RVEN), a device that facilitates successful venipuncture, particularly of veins that are difficult and problematic to access due to condition of the vein, condition of the skin, patient health, and body structure. Failed attempts at venipuncture increase the probability of complications, particularly with catheterization procedures. PRII will optimize and test a prototype to reduce the insertion force necessary for central venous catheterization (CVC), venipuncture, and other difficult vein access procedures. For certain patients (e.g. pediatric, elderly and obese), venipuncture can be quite difficult and painful. Collapsed veins, rolling veins, scar tissue, obesity and hardened veins are some of the factors that make venipuncture problematic. Venipuncture is also one of the most painful procedures for a child. Various approaches are used for both children and adults to alleviate the pain caused by needle insertion, which is crucial for patients who undergo repeated needle insertions (e.g. dialysis patients). Treatments to mitigate pain (e.g. topical analgesics and pre- injection with a smaller needle) are costly, time consuming, and often ineffective. A medical device that could overcome difficulties and reduce pain would have many applications. While the RVEN has potential to impact a wide range of procedures, CVC venipuncture has been selected as a starting point. Clinician evaluation in real tissue models will be a key focus of Phase I. More than five million central venous catheters (CVCs) are inserted yearly in the United States. The use of CVCs is associated with adverse events that are both hazardous to patients and extremely expensive to treat. More than 15 percent (~750,000 per year) of patients who receive CVCs have complications, which can be placed into three general categories: insertion, indwelling and extraction. Complications associated with insertion include patient discomfort, tissue damage, infection, misplacement, and arterial puncture. The annual cost of treating just one type of CVC complication (i.e. infection) ranges from 296 million to 2.3 billion. Factors that increase the likelihood of complications include clinician inexperience, number of needle insertions, body mass index, and large catheter size (which is more likely with CVCs). Unsuccessful insertion attempts are the strongest predictor of insertion complications. The incidence of complications rises with two venipunctures to a six-fold increase with three or more. A device that increases insertion success rate and reduces complications has medical need and commercial viability, especially as patient populations with difficult vein access (e.g. elderly and obese patients) increase. PUBLIC HEALTH RELEVANCE: Relevance - For certain patients (e.g. pediatric, elderly and obese), venipuncture can be quite difficult and painful. Collapsed veins, rolling veins, scar tissue, obesity and hardened veins are some of the factors that make venipuncture problematic. In this Phase I NIH SBIR, Piezo Resonance Innovations will design and demonstrate feasibility of the Resonance Driven Vascular Entry Needle (RVEN), a device that facilitates successful venipuncture, particularly of veins that are difficult and problematic to access due to condition of the vein, condition of the skin, patient health, and body structure.