Med Device: The STAT-Clip Prevents Blood Leakage upon Intra-Venous Catheter Insertion

Intra-Venous Catheter (IVC) placement is one of the most common invasive medical procedures performed. However quite often blood leaks occur while the IVC is being initially installed, allowing for exposure to blood-borne pathogens, such as those that cause Hepatitis and HIV, for both patients and healthcare professionals. The STAT-Clip is a device that allows for one-handed automatic catheter closure. An IV is started in the usual manner and as soon as the needle is pulled out, the clamp pinches the catheter, blocking the flow of blood. This system prevents any possible leakage and thus lowers the number of Hospital Acquired Infections. It is inexpensive to produce and provides a safer and easier method of inserting IVCs.

COMMERCIAL OPPORTUNITY

  • Blood exposure risks begin when a catheter is inserted into a vein or artery, and continues until the IV supply tubing is connected to the catheter. The person starting the IV prevents blood leakage with finger pressure on the vessel, above the entry point, then they use the other hand to retract the needle and put it aside, find and connect the IV tube fittings, verify flow, and then finally tape everything down. All with one hand.
  • It is estimated that 800 million to 1.5 billion IV procedures are done a year worldwide. In 2011, there were about 197 million IV procedures done in the US. About 35% of all IV procedures result in accidental blood spills or leaks. In 2002, there were 1.7 million hospital acquired infections, which were involved in 99,000 deaths. Treatments costs ranged from $4,000 to over $40,000.
  • This is an attractive market as evidenced by the introduction of two devices, Becton Dickinson’s BD Insyte™ Autoguard™ BC shielded IV catheter with blood control technology, and Smiths Medical’s ViaValve® Safety IV Catheter, which are more complex, expensive, and affect current techniques. The STAT-Clip prototype was preferred by nurses and technicians in hands-on sessions due to its simplicity.
  • Manufacturing firms have provided quotes for sterile single-use device costs of less than $0.50 at reasonable volumes. Regulatory analysis suggests the device falls under the FDA Class I device category where clinical trials and pre-market testing are not required.

TECHNOLOGY

The alignment of clamping bodies 40, when in the closed position, is achieved by the synergistic movement of the finger pads 50 and alignment members 60. Alignment bodies 46 are respectively engaged by bodies 46 of the opposite engagement body 40. Protrusions 46 overlap and nest such that clamping surfaces 44 are maintained in axial alignment. When the user relaxes or ceases the applied force, the outwardly biasing force will cause the engagement bodies 40 to come into contact with the two clamping surfaces 44 in contact with the catheter held there between.

PUBLICATION/PATENT

  • US Patent filed November 3, 2016 for Dr. Tariq Chaudhry, Scott Hampton, and Stephen Braun

Contact

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

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