Israeli device goes straight to the bone

WaisMed’s Bone Injection Gun (BIG) enables a medic to bypass the veins and penetrate the tibia within seconds to inject saline or medications into the marrow.Whether on the battlefield or in the emergency room, when first responders arrive to treat …

WaisMed’s Bone Injection Gun (BIG) enables a medic to bypass the veins and penetrate the tibia within seconds to inject saline or medications into the marrow.Whether on the battlefield or in the emergency room, when first responders arrive to treat a critically injured patient, they sometimes cannot administer vitally needed intravenous fluid.

Either the veins have collapsed or in the cases when blood pressure is low, such as heart attacks or unconsciousness, veins contract and are hard to find.

American emergency personnel serving in Iraq and Afghanistan know this as well as anyone, which is why they’ve come to rely on a novel Israeli-made device – WaisMed’s Bone Injection Gun (BIG) which enables a medic to bypass the veins and penetrate the tibia within seconds to inject saline or medications into the marrow.

The BIG is the world’s first automatic intraosseous (IO) infusion device, and was invented by Dr. Marc Waisman – an orthopedic surgeon. Not quite a needle, the device is described by WaisMed’s CEO Mickey Flint as “a simple tube with a trigger that is released.”

This “simple tube” is saving lives around the world. It is being used throughout the American military – not only by many units in Iraq and Afghanistan – but also by the CIA, the Department of Homeland Security and the Department of Health and Human Services. Other customers include American hospitals, emergency medical service providers and fire departments.

Medical studies have proven that survival rates for serious field casualties often depend on the key factor of immediate administration of fluids to stabilize shock And when every second counts, delays in placing an IV line can be fatal. According to Flint, when intravenous injection is not working, the BIG device provides rapid, safe and easy intravascular access through the bone marrow.

The IO’s method was discovered in 1922, and was in wide use through the 1940s, but over the years was pushed aside as polymer intravenous catheters and needles become more widespread. However, according to Flint, the problem with intravenous methods is finding a vein. And an even greater problem is infection as a result of injection.

“IO functions the same way as intravenous – but it works straight into the bone, instead of the veins,” Flint told ISRAEL21c. “When you use intravenous injection, blood pressure can go down and the vein can be in danger of collapse. However, when you inject into the cavity inside bone, it raises the pressure inside and fluid and medication are diffused in the blood circulation.”

Flint pointed out that intravenous delivery can also cause infection in about 4% of cases and is ineffective in another 10% of patients forcing medics to switch to a major artery. The process can take at least six minutes – vital time if the patient is in a life-threatening situation.

Brian Petrilla, a paramedic in Tomball, Texas, told the AIPAC Near East Report that the BIG is a huge improvement over inserting an endotracheal intubation tube when an IV cannot be inserted in a vein. He said, BIG “made the difference” last December in resuscitating a heavy-set man who had gone into cardiac arrest, by quickly getting drugs into his system.

According to Flint, the American Heart Association has already recommended the IO technique for use in pediatrics (who have small, hard to find veins) as an alternative to intravenous, advising that after two failed attempts at inserting IV or after 90 seconds, then IO should be implemented.

Flint says paramedics who once carried out IO procedures once a year now do it 15-20 times a year, and he predicts that this figure will rise.

“We hope that now the AHA is about to recommend the same procedure for adults,” he said. A recent posting on the Paramedics professional forum Paramedics.com touted the praises of the BIG for adult use.

“Our service just performed its first Adult I/O with the Waismed BIG with phenomenal results. Code-Blue male in asystole, intubated w/ first round down the tube, pacing, and I/O in medial tibia. Got return of pulses in ED and resps later. Had to use a pressure bag to infuse fluids and meds, other than that, excellent results,” read the post from an American paramedic.

The Casearea-based WaisMed was founded at Technion Entrepreneurial Incubator Co. Ltd. (TEIC) in 1995. Even though the company obtained U.S. Food and Drug Administration (FDA) approval for its device in 1999, it ceased operating in 2000 due to financial difficulties before ever bringing the BIG to market.

“Dr. Waisman originally approached me to help raise funds to keep the company going,” said Flint who comes from a marketing and advertising background.

He eventually resuscitated the business in 2002 with the financial assistance of Israeli businessmen Eitan Wertheimer and Ami Lapidot.

In June 2004, the Persys Group acquired WaisMed together with Flint, one of whose companies – Performance Systems – markets WaisMed?s device to the U.S. Army. Over 500 units are being used by special U.S. army units in Iraq and Afghanistan, over 20,000 have been used worldwide, said Flint.

He credits the BIG’s success to its innovative, patented injection system, calling it the only IO device on the market that is spring loaded.

“We initially designed the device like a gun, but this created problematic psychological connotations. So we redesigned it like a syringe, but that also didn’t do the trick. We still call the device a ‘Bone Injection Gun’, in order to explain the speed and automated action, but it is designed as a simple tube with a trigger that is released,” he told Globes.

According to Flint, WaisMed is also looking into other markets for the BIG besides emergency IO, including veterinary medicine which will solve the pesky problem of getting animals to lie down until a vein can be found.

Another market is IO local anesthesia for limb surgery, when quick anesthesia is needed for emergency procedures if the patient’s condition or location of the injury makes intravenous procedures impossible.

But its primary use will undoubtedly continue to be its emergency IO procedure – used today in 18 countries. In hospitals, in many cases, it is eliminating the need to place a Central Venous Catheter (CVC), while in the field – both civilian and military – the BIG provides a safe, quick and easy solution when patient’s condition makes IV placement difficult or impossible.