Published On June 10, 2015
It takes a full hour, on average, for a soldier who has been wounded to arrive at a medical facility for treatment. By then, the soldier is often beyond saving, frequently because of internal bleeding.
David King, a trauma and acute care surgeon at Massachusetts General Hospital and combat surgeon for the US Joint Special Operations Command, has led an interdisciplinary collaboration to develop a technology that can help: ResQFoam. This trauma foam is created when two liquids are injected into the abdomen where they combine and expand to 35 times their original volume. The foam applies pressure to internal organs and staunches internal bleeding.
What was the problem you aimed to fix?
Right now there is no treatment for bleeding where it can’t easily be staunched with a compress or tourniquet. It is a huge unmet need that has been around for decades.
What spurred your idea to use foam?
This idea of having a so-called abdominal fix-a-flat has been around for quite some time. You get a flat tire, squirt this goop in to seal the hole and you can drive on it until you get the tire changed. In the case of abdominal hemorrhage, the notion is to squirt something in, have it plug up whatever is bleeding and prolong life. That concept is not new, but our technological approach was an innovation.
How was your approach different?
There have been tens of millions of dollars, maybe even hundreds of millions, invested in solving this problem without really getting anywhere. We pulled every historical study we could find and looked at what those investigators did and why they failed. We then tried to create an approach that avoided all those pitfalls.”
How long did that take?
When asked about his failures inventing the light bulb, Thomas Edison supposedly said that he had not failed; rather he had successfully discovered 1,000 ways not to make a light bulb. Well, we know 1,200 ways not to make foam. But this failure process allowed us to find the one formula that was an effective treatment for internal bleeding.
We are taking two liquids, mixing them and turning them into a solid in a time frame of just minutes. There is a lot of complex chemistry going on. And the moment you start altering one part of the chemistry to solve a problem, that has a variety of other effects. We thought we had it solved, we tried it, it wouldn’t work and we went back to the drawing board over and over again. And it took years.
Any dangers in this technology?
The major complications we have seen are small bowel lesions, probably a result of pressure from the foam. It is a give and take. If you give a low dose, you don’t have many side effects, but the patient bleeds to death. If you have a very high dose you can stop all bleeding, but there is so much bowel damage that it probably can’t be surgically repaired.
So we had to conduct a study to find the sweet spot with the best balance of safety and efficacy. Where we ended up probably doesn’t stop bleeding altogether, but it takes torrential bleeding and turns it down to a trickle. This allows patients who normally would die in five minutes to survive three hours, with a reasonable number of bowel injuries that a surgeon can easily repair.
How were you able to test the foam in people?
We came up with a unique study that had never been done before—we injected varying amounts of foam into the abdominal cavities of recently deceased human beings. This procedure had to be done within two to three hours of death because the temperature and tissue compliance of the body matters—the foam behaves differently at different temperatures so we had to test it in conditions that closely resembled a living person. As a result, we were able to test the right human doses that would minimize bowel damage without putting live humans at risk.
Did you have any trouble finding subjects willing to participate?
To my surprise, when I approached patients who were on their death bed and asked them if they would be willing to serve as subjects, we received nearly a 50% participation rate. It is one thing to say this is addressing an unmet military problem overseas. But when you say there are applications of this technology right here in Boston, people get it. They understand the importance of what we are doing.
When do you think the foam will be approved for use in live humans?
We have been having conversations with people at the Food and Drug Administration for the past few years, while we’ve been developing ResQFoam, and now we’re about to submit our application. Yet while they definitely recognize the urgent need for this development, there is no precedent for this type of life prolonging technology. Unlike many other medical devices, the safety and effectiveness our trauma foam can only be determined by using it on uncontrollable bleeding cases in the field. Although I believe it should be through in about 6 months, you never truly know for sure when it comes to FDA approval.
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