Med Device: Safety Catheter with Needle and Blood Exposure Prevention Systems

Catheters are widely used for administering fluids and medication or drawing blood for analysis. The disclosed invention is a sealed catheter with a retractable needle and an enclosed area that contains the retracted needle and collects any leaked blood. Compared to the existing catheters, the procedure using this catheter does not require removing the contaminated needle out of the catheter, thereby preventing accidental needle injury. There is also no exposure to blood in the operating room. This invention is safer than existing devices on the market.

COMMERCIAL OPPORTUNITY

  • Intra-venous (IV) catheter placement is a procedure done over a billion times a year worldwide, and it is estimated that approximately a third of the time there are blood leaks that could result in exposure to blood-borne communicable pathogens.
  • Catheters with needle safety features are important in helping prevent accidental needle stick injuries, as there is the potential transmission of over 20 bloodborne pathogens. The National Institute for Occupational Safety and Health (NIOSH) estimates that the risk of HIV infection is about 1 in 300 (0.3%), and the risk of HCV infection is about 1.8%. A healthcare journal (AOHP Journal) published an article in 2013 indicating that over 320,000 needlestick injuries occur every year in the US.
  • Because of the occupational and public health hazards posed by conventional disposable syringes, Federal legislation was signed into law on November 2000, by President Clinton that became effective for most states in April 2001 that requires the use of safety needles for most procedures.
  • The market may become more robust, once litigation ends that has been ongoing between Becton Dickinson (BD) and Retractable Technologies (RTI). RTI claims to have been blocked from access to the market by the business practices of BD. RTI initiated a lawsuit in 2007 against BD, and was awarded $340 million in antitrust damages in 2013. On December 2, 2016, the Fifth Circuit Court of Appeals overturned the previous award, but affirmed a finding of false advertising liability against BD and remanded the case for a redetermination of damages. The new trial date is May 11, 2017.

TECHNOLOGY

Functionality is straightforward and fits well with existing methods: upon identifying a vein, it is accessed in the traditional manner, with the needle and catheter entering the vein, and then the needle is withdrawn using the slider, and the assembly is hooked up to IV fluid tubing. This technique avoids contaminated needle or blood exposure seen with the traditional IV catheters.

PUBLICATION/PATENT

  • Provisional patent filed for Dr. Tariq Chaudhry on November 4, 2016.

Contact

Haskell Adler PhD MBA CLP
Senior Licensing Manager
Registered Patent Agent
Haskell.Adler@Moffitt.org
(813) 745-6596

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