The father of catheter innovations speaks up

Ron Luther looks into his crystal ball

When Ronald B. Luther talks, the home infusion industry listens — and with good reason. The founder and former chairman of Luther Medical Products, recently purchased by Becton-Dickson in Sparks, MD, has been one of the leading forces in the development of the catheter industry for the past several decades.

Now, he’s back after stepping down from Luther Medical Products in 1997. Luther recently formed Luther Research Partners and is looking to introduce his three latest inventions to the catheter market. In this exclusive interview with Home Infusion Therapy Management, Luther provides insight into his latest innovations for the catheter market.

"I left Luther Medical in November of 1997. Since then, I have three patents on file which represent the distillation of the 39 patents I left at Luther," says the inventor.

Each of his new inventions are aimed at a specific segment of the infusion market. The first of his inventions he hopes to get to the market is a PICC (peripherally inserted central catheter) inserter.

"I have invented an inserter for PICC lines that uses a peel-away needle (not the Luther peel-away needle). As you finish with the needle, the two needle halves are trapped in a container, so there is no danger of secondary needlesticks," he says.

The second invention is aimed at a much larger market. While the market for PICCs is only about $40 million in the United States, according to Luther, the market for short catheters is $700 million worldwide, and $350 million to $400 million in the United States. Luther’s most famous invention, the ProtectIV, was aimed at this market.

"For this market, I have concentrated not only on needle protection, but to give the patient more benefits," he says. "I have invented an entirely new type of over-the-needle catheter that benefits the patient and the caregiver, that requires no additional training on the part of the nurses. A company can hand this to a nurse and [say], Insert this like you would insert any over-the-needle catheter.’"

Multiple uses

Other than the dual benefits, Luther says the catheter will have a huge advantage in Third World countries.

"This catheter can be sold in lesser-developed countries because it can be reused many times," notes Luther. "The patient will take the inserter part of the catheter and wear it around his neck like a thermometer container. When his therapy is finished, you pull the catheter, reassemble the inserter, clean it and reuse it. This can probably be used 100 times due to the uniqueness of its construction."

Luther notes that he is aiming at the U.S. market, though, for which he says the benefits over current short catheters are numerous.

"All over-the-needle catheters today, once you use them, you tear up the tip and it’s deformed," he explains. "I am putting a hard tip and a new type of inserter, so there is no danger of a secondary needlestick. It’s more comfortable for the patient."

The catheter will also be made of very soft material, a lesson he learned at Luther Medical.

"With this catheter, you’re going to put in a softer catheter than any of the other catheters. A soft catheter stays in longer," Luther says. "The new urethanes coming out are softer, stronger. You can make them more radiopaque,’ and they are biocompatible. I have not been a fan of silicone, because of the weakness of the material. You can get so much more flow out of urethane with thinner walls."

The third and final patent involves a catheter finder that should be far and away the most economical on the market, adding just pennies to the cost of the catheter.

"The benefit is that any time the patient is checked — this is mostly for PICC lines in the home — you don’t have to X-ray them," says Luther. "You can take this catheter finder — it’s like a pencil with a row of lights on it — and run it up the patient’s arm to verify exactly where the catheter is and where the tip is. You don’t have to take the patient in for an X-ray."

Luther says he will probably give away the detector with any of Luther Research’s catheters, or put something in the catheters themselves that will add very little cost to the catheter.

Now what?

Luther notes that, at this point, he has little control over when the above products hit the market.

"From the date I get funding or a partner, you can expect to see these products on the market in a year, because most of the development is done."

However, when the funding becomes available is anyone’s guess. "I’ve got to raise $3 million to start the company, and there are two avenues I am looking at," Luther says. "One is to hire a professional moneyraiser who will approach a group of individuals. Or the way I would prefer is to get a partner early, such as a medical company that would be interested in the types of products I have filed patents on. The focus of the new company will be to ally ourselves with one of the larger medical companies and not try to go it alone like Luther Medical did."

Although preliminary discussions have been held with few companies — already three have expressed an interest — Luther says he still must raise funds to build prototype catheters and conduct clinical tests to prove his claims.

Stay focused

Luther notes there are three industry trends that will guide the design of any catheter he introduces to the market.

"There’s one giant bear looming over all of us, and that is the requirement for safety devices," he explains. With California legislation already passed and numerous other states ready to follow suit, it may be just a matter of time before all providers are required to use safety devices such as needleless tubing and safety catheters. This presents a challenge to manufacturers as well, according to Luther.

"That is going to impose a big burden on the companies who have these safety products for inservice," he says. "We need to consider how we can get around inservices. What you have to do is provide the safety without the inservice."

The second area is the always-present concern of exposure to blood.

"You want to eliminate as much blood as possible on a catheter insertion," he says. "Right now on every over-the-needle catheter, any time you pull the needle out of the inside of that catheter, you have blood squirting out the back of it. That’s another thing we’ve set out to eliminate."

Lastly, Luther wants to dramatically reduce the frequency of needlesticks. As already mentioned, one way to do this is to design catheters that can remain in place for the duration of a patient’s therapy.

"If you keep the safety of the caregiver in mind, eliminate the blood, and get a more comfortable catheter that can last longer, then you have some very worthwhile objectives that will allow you to compete in that giant market," says Luther.

Gimmick can’t sell itself

The wrong way to go about it is to introduce a novelty and think that a new modification itself will sell the catheter.

"Some people come out with one gimmick on a catheter, like a valve in the hub," says Luther. "But that is not enough to make people change. You have to have the whole catheter, starting with the tip. You have to have a tip that is at least comparable to those on the marketplace. If your catheter doesn’t go in as easy as theirs, you’re out of business right there because the nurses aren’t going to accept it."