This one is too easy by half. The fluids are shot into the injury
and contained while it encapsulates the wound itself, halting
bleeding. It is a three hour bridge that is enough to save most.
It certainly surpasses the old pressure bandage.
This will quickly find its way into motor vehicle accidents and the
related paramedic training. In practice, paramedic training is
advancing and improving apace. It is the first stage in recovery and
we are slowly solving the worst cases. It is becoming more and more
possible to survive the event. It will always be touch and go, but
this means that bleeding out after the paramedics arrive is less of a
risk.
DARPA FOAM COULD
INCREASE SURVIVAL RATE FOR VICTIMS OF INTERNAL HEMORRHAGING
December 10, 2012
Technology developed
under DARPA’s Wound Stasis System program resulted in 72 percent
survival rate at three hours post-injury in testing
The Department of
Defense’s medical system aspires to a standard known as the “Golden
Hour” that dictates that troops wounded on the battlefield are
moved to advanced-level treatment facilities within the first 60
minutes of being wounded. In advance of transport, initial
battlefield medical care administered by first responders is often
critical to injured service members’ survival. In the case of
internal abdominal injuries and resulting internal hemorrhaging,
however, there is currently little that can be done to stanch
bleeding before the patients reach necessary treatment facilities;
internal wounds cannot be compressed the same way external wounds
can, and tourniquets or hemostatic dressings are unsuitable because
of the need to visualize the injury. The resulting blood loss often
leads to death from what would otherwise be potentially survivable
wounds.
DARPA launched its
Wound Stasis System program in 2010 in the hopes of finding a
technological solution that could mitigate damage from internal
hemorrhaging. The program sought to identify a biological mechanism
that could discriminate between wounded and healthy tissue, and bind
to the wounded tissue. As the program evolved, an even better
solution emerged: Wound Stasis performer Arsenal Medical, Inc.
developed a foam-based product that can control hemorrhaging in a
patient’s intact abdominal cavity for at least one hour, based on
swine injury model data. The foam is designed to be administered on
the battlefield by a combat medic, and is easily removable by doctors
during surgical intervention at an appropriate facility, as
demonstrated in testing.
Wound Stasis
performers presented pre-clinical data on the foam treatment at the
2012 Annual Meeting of the American Association for the Surgery of
Trauma in Kauai, Hawaii. These data demonstrated the ability of
the foam to treat severe hemorrhage for up to three hours in a model
of lethal liver injury. During testing, minimally invasive
application of the product reduced blood loss six-fold and increased
the rate of survival at three hours post-injury to 72 percent from
the eight percent observed in controls.
“Potentially, Wound
Stasis provides an important addition to our ability to save life and
limb. Getting after these heretofore difficult-to-stabilize, if not
untreatable wounds, expands our options and effectively extends the
‘Golden Hour,’” said Maj. Gen. Bill Hix, Director of Concept
Development for the Army Capability Integration Center at Training
and Doctrine Command. “A capability like this is important in any
operation, but would prove vital during operations in austere areas
where military resources and infrastructure are at a premium,” he
said.
“Wound Stasis has
been an exciting program because we were able to move unexpectedly
from fundamental research to a pre-clinical proof-of-concept based on
the strength of our findings,” said Brian Holloway, DARPA
program manager. “According to the U.S. Army Institute of Surgical
Research, internal hemorrhage is the leading cause of potentially
survivable deaths on the battlefield, so the Wound Stasis effort
should ultimately translate into an increased rate of survival among
warfighters. If testing bears out, the foam technology could affect
up to 50 percent of potentially survivable battlefield wounds. We
look forward to working with the U.S. Food and Drug Administration on
future regulatory submission of this device, and with our partners,
the Army Institute of Surgical Research and Special Operations
Command, on getting this technology to where it’s desperately
needed on the front lines.”
The foam is actually a
polyurethane polymer that forms inside a patient’s body upon
injection of two liquid phases, a polyol phase and an isocyanate
phase, into the abdominal cavity. As the liquids mix, two
reactions are triggered. First, the mixed liquid expands to
approximately 30 times its original volume while conforming to the
surfaces of injured tissue. Second, the liquid transforms into
solid foam capable of providing resistance to intra-abdominal blood
loss. The foam can expand through pooled and clotted blood and
despite the significant hydrostatic force of an active hemorrhage.
In tests, removal of
the foam took less than one minute following incision by a surgeon.
The foam was removed by hand in a single block, with only
minimal amounts remaining in the abdominal cavity, and with no
significant adherence of tissue to the foam. Features appearing
in relief on the extracted foam showed conformal contact with
abdominal tissues and partial encapsulation of the small and large
bowels, spleen, and liver. Blood absorption was limited to near the
surface of the foam; the inside of the foam block remained almost
uniformly free of blood.
DARPA recently awarded
a $15.5 million Phase II contract to Arsenal Medical to continue
development of the treatment system and support regulatory
submission. DARPA anticipates continuing the Wound Stasis program
through at least FDA approval of a prototype device.
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