A new intravenous catheter insertion system designed by Dartmouth Medical School anesthesiology professor Christopher Wiley could lead to improved patient comfort and increased cost efficiency, according to Martin Doyle, medical CEO of Balch Hill Medical Group, which is working with Wiley on developing the product. Wiley's innovation, the PrecisionThread system, is still in pre-marketing stages and is currently pending FDA approval, Wiley said in an interview with The Dartmouth.
The PrecisionThread system may increase the success rate of IV insertion by up to 75 percent, Doyle said, though Wiley said that figure has not yet been confirmed by tests.
One problem common with current systems is a false "blood flashback" signal, Wiley said, in which the release of blood into the needle indicates to a technician that the needle has entered the vein, but does not guarantee that the catheter has.
The PrecisionThread's design, however, features a catheter that is much closer to the opening of the needle, so that a blood flashback is a better indicator that both the needle and the catheter have entered the vein, Wiley said.
Current catheter systems are also hampered by the potential for the needle to pierce the back wall of the vein if pushed too far. Other physicians have attempted to improve the success rate of IV insertion by focusing on this problem, Wiley said, but many of these other designs actually increased the likelihood of the catheter not entering the vein.
"You're really just trading one problem for another," Wiley said. "A truly effective design, I think, needs to address both problems. Not just one or the other."
The PrecisionThread device has a rounded keel at the end of the needle that allows the needle to skid across the back wall of the vein, rather than piercing it, he said.
With the help of Balch Hill, Wiley has developed a prototype of the PrecisionThread device that can be used on plastic vein models, though he must obtain FDA approval which could take several months before proceeding to human tests, he said.
Last week, Wiley presented his invention at the American Society of Anesthesiologists 2009 annual meeting, where he said he received positive feedback from doctors, technicians and nurses who tried the device on plastic vein models.
Wiley has now begun working with Balch Hill, which helps local doctors develop product prototypes and bring finalized designs to the market.
Although there are currently no set plans to market the product, Doyle said the PrecisionThread would likely take one of two paths typical of inventions that result from collaborations between DHMC doctors and Balch Hill: Either Balch Hill can develop the design, and then manufacture and sell the finished product itself, or the company can sell the design to a larger manufacturer that will produce the product under its own label.
In both scenarios, Balch Hill would purchase the intellectual property from the College, and then pay Dartmouth royalties based on a percentage of sales.
Doyle described deciding between these two options as "the entrepreneur's dilemma."
Wiley said that his preferred path would be to have Balch Hill sell the design to a larger manufacturer to license the product, as Balch Hill does not currently produce IV catheters.
While manufacturing the product internally usually brings Balch Hill and by extension, Dartmouth more money, Balch Hill would need a significant capital investment in order to develop the capabilities to manufacture IV catheters, Doyle said, which could lead the group to favor an outside manufacturer for the product.
