INVENTION: Gunshot Wound Sealed within 15 seconds

[ChunkyMonkey]

http://www.popsci.com/article/technology/how-simple-new-invention-seals-gunshot-wound-15-seconds


How A Simple New Invention Seals A Gunshot Wound In 15 Seconds


An Oregon startup has developed a pocket-size device that uses tiny sponges to stop bleeding fast.



By Rose Pastore (http://www.popsci.com/category/popsci-authors/rose-pastore)


Posted 02.03.2014 at 2:30 pm

http://www.popsci.com/sites/popsci.com/modules/bonnier/post_social/theme/post_icon_24.png (http://www.popsci.com/article/technology/how-simple-new-invention-seals-gunshot-wound-15-seconds#)
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http://www.popsci.com/sites/popsci.com/files/styles/image_full/public/xstat.jpg?itok=fIJV3IN0XStat
RevMedx

When a soldier is shot on the battlefield, the emergency treatment can seem as brutal as the injury itself. A medic must pack gauze directly into the wound cavity, sometimes as deep as 5 inches into the body, to stop bleeding from an artery. It’s an agonizing process that doesn't always work--if bleeding hasn't stopped after three minutes of applying direct pressure, the medic must pull out all the gauze and start over again. It’s so painful, “you take the guy’s gun away first,” says former U.S. Army Special Operations medic John Steinbaugh.
Even with this emergency treatment, many soldiers still bleed to death; hemorrhage is a leading cause of death (http://www.ncbi.nlm.nih.gov/pubmed/21795876) on the battlefield. "Gauze bandages just don't work for anything serious," says Steinbaugh, who tended to injured soldiers during more than a dozen deployments to Iraq and Afghanistan. When Steinbaugh retired in April 2012 after a head injury, he joined an Oregon-based startup called RevMedx, a small group of veterans, scientists, and engineers who were working on a better way to stop bleeding.
http://www.popsci.com/sites/popsci.com/files/styles/image_full/public/xstatbeforeafter.jpg?itok=0nFwFpiXXStat, before and after
RevMedx

RevMedx recently asked the FDA to approve a pocket-size invention: a modified syringe that injects specially coated sponges into wounds. Called XStat, the device could boost survival and spare injured soldiers from additional pain by plugging wounds faster and more efficiently than gauze.
The team’s early efforts were inspired by Fix-a-Flat foam for repairing tires. “That’s what we pictured as the perfect solution: something you could spray in, it would expand, and bleeding stops,” says Steinbaugh. “But we found that blood pressure is so high, blood would wash the foam right out.”
So the team tried a new idea: sponges. They bought some ordinary sponges from a hardware store and cut them into 1-centimeter circles, a size and shape they chose on a whim but later would discover were ideal for filling wounds. Then, they injected the bits of sponge into an animal injury. “The bleeding stopped,” says Steinbaugh. “Our eyes lit up. We knew we were onto something.” After seeing early prototypes, the U.S. Army gave the team $5 million to develop a finished product.
But kitchen sponges aren’t exactly safe to inject into the body. The final material would need to be sterile, biocompatible, and fast-expanding. The team settled on a sponge made from wood pulp and coated with chitosan, a blood-clotting, antimicrobial substance that comes from shrimp shells. To ensure that no sponges would be left inside the body accidentally, they added X-shaped markers that make each sponge visible on an x-ray image.
“By the time you put a bandage over the wound, the bleeding has already stopped.”
The sponges work fast: In just 15 seconds, they expand to fill the entire wound cavity, creating enough pressure to stop heavy bleeding. And because the sponges cling to moist surfaces, they aren’t pushed back out of the body by gushing blood. “By the time you even put a bandage over the wound, the bleeding has already stopped,” Steinbaugh says.
Getting the sponges into a wound, however, proved to be tricky. On the battlefield, medics must carry all their gear with them, along with heavy body armor. RevMedx needed a lightweight, compact way to get the sponges deep into an injury. The team designed a 30 millimeter-diameter, polycarbonate syringe that stores with the handle inside to save space. To use the applicator, a medic pulls out the handle, inserts the cylinder into the wound, and then pushes the plunger back down to inject the sponges as close to the artery as possible.
http://www.popsci.com/sites/popsci.com/files/styles/image_full/public/2.jpg?itok=Be2FLRlcXStat sponges
RevMedx

Three single-use XStat applicators would replace five bulky rolls of gauze in a medic’s kit. RevMedx also designed a smaller version of the applicator, with a diameter of 12 millimeters, for narrower injuries. Each XStat will likely cost about $100, Steinbaugh says, but the price may go down as RevMedx boosts manufacturing.
If the FDA approves XStat, it will be the first battlefield dressing created specifically for deep, narrow wounds. Gauze, the standard treatment for gunshot and shrapnel injuries, is only approved by the FDA for external use, but “everyone knows that if you get shot, you have to pack gauze into the wound,” says Steinbaugh. When RevMedx submitted its application to the FDA, the U.S. Army attached a cover letter requesting expedited approval. According to Steinbaugh, RevMedx and the military are now in final discussions with the FDA.
Last summer, RevMedx and Oregon Health and Science University won a seed grant (http://www.savinglivesatbirth.net/news/13/07/31/press-release-round-3-award-nominees-announced), sponsored by The Bill & Melinda Gates Foundation, to develop a version of XStat to stop postpartum bleeding. In the future, RevMedx hopes to create biodegradable sponges that don’t have to be removed from the body. To cover large injuries, like those caused by land mines, the team is working on an expanding gauze made of the same material as XStat sponges.






“I spent the whole war on terror in the Middle East, so I know what a medic needs when someone has been shot, ” Steinbaugh says. “I’ve treated lots of guys who would have benefitted from this product. That’s what drives me.”

[Aloha_Shooter]

Good stuff. The War in Iraq has definitely had some silver linings with incredible advances in medical procedures and equipment as well as prosthetic development. In a way, it's a shame it takes war to jumpstart some of these advances but at least there's some good coming out of the battlefield sacrifices.

[Irving]

They already have this. Celox vame out with a big plastic syringe that you jam into the wound and inject the hemostatic agent.

[ChunkyMonkey]

They already have this. Celox vame out with a big plastic syringe that you jam into the wound and inject the hemostatic agent.

I think you are talking about Celox applicator which is designed for small cut where the granules couldn't be effectively pushed in. XSTAT took it a step further by having the blood clotting agent on the sponge/gauze. The big difference is when you use celox and the bleeding doesnt stop, you must pull the gauze and reapply & rebandage. XStat supposedly addresses that issue.. plus it taste like seafood :)

[firefighter238]

Just about ANYTHING is better than QuickClot! *sizzle sizzle*

[rbeau30]

Just about ANYTHING is better than QuickClot! *sizzle sizzle*

More fun when you get it in your eyes.

[Irving]

Just about ANYTHING is better than QuickClot! *sizzle sizzle*
The kind that burns you has been off the market for awhile apparently.

Chunky: The Celox applicator is about as big around as your middle finger, so definitly not for small cuts. Well it IS for smaller wounds, but the applicator is so big that it seems like it would be equal to pacjing the wound with your finger. Chris should chime in soon.

[cofi]

Would this not be ok for people with shellfish allergy???

[cmailliard]

I have not done much research on this product yet. There is new info that talks about the pressure difference from inside a wound to the outside and that it helps control bleeding. This idea with the sponge and chitosan may take advantage of the pressure and hemostatic agent for hemorrhage control. I am not sure what duration of direct pressure is needed with this product (remember most Hemostatic Agents need 3-5 minutes of direct pressure after application), it says 15 seconds. . . . but let's see.

It looks like a promising product, let's see some good third party (USAISR) testing against Combat Guaze, and if it works get in TCCC and in the field.

[cmailliard]

One other thing to consider why this may work really well is how much material is in it. One of the latest studies showed that the more agent (Combat Gauze, Celox Gauze, etc) you have the better it works. With the wound packing task trainer I have I am seeing this first hand. If this product has more hemostatic agent in it, it may work better. More agent and more "stuff" filling the void = faster hemostasis. They may have found that combination with an easy way to apply.

[ChadAmberg]

Would this not be ok for people with shellfish allergy???

I don't think that Chitosan has protein in it that folks are allergic to. Chitosan counts more as dietary fiber...

[ChunkyMonkey]

Would this not be ok for people with shellfish allergy???

Pick your allergy! Shellfish or lead? :D


Sent from my iPhone using Tapatalk

[Akyla]

Interesting. Thanks for posting. I'm definitely curious to see some real world usage. I hope it works.

[Mick-Boy]

It looks like an interesting product. I'd like to see some independent third party testing too. I'd also be curious to know what trauma surgeons would think about dozens of little sponges packed into a wound.

Getting a bunch of material into the wound cavity, and if you're using hemostatic agents getting them as close to the actual bleed at possible, is definitely going to help with clotting. No doubt about it.

(FYI - Chitosan shouldn't have any effect on people with shelf fish allergy and if the quick clot you have is still the powdered stuff that burns you need to toss it and spend the $50 on the new stuff.)

[osok-308]

It will be really cool to see this in action... not on someone with a gunshot wound, just see it expand in water (yes I am a child).

[Mick-Boy]

It will be really cool to see this in action... not on someone with a gunshot wound, just see it expand in water (yes I am a child).

I've got you covered.


http://www.youtube.com/watch?v=nh6_bNNUpIo

[rbeau30]

I've got you covered.


http://www.youtube.com/watch?v=nh6_bNNUpIo


I want some! DINOSAURFARM! http://www.dinosaurfarm.com/dinbatcap.html

[HoneyBadger]

Very cool!

[MarkCO]

Looks promising.

[Aloha_Shooter]

Chunky: The Celox applicator is about as big around as your middle finger, so definitly not for small cuts. Well it IS for smaller wounds, but the applicator is so big that it seems like it would be equal to pacjing the wound with your finger. Chris should chime in soon.

Irving, the article said the applicator was 30 mm (approximately 1.2 inches) in diameter but there was a smaller applicator only 12 mm (approximately half an inch) in diameter for narrower wounds.

[cofi]

I spent a LONG time talking to the RevMed guys and posted about them during SHOT. It was founded by an active duty Special Forces Medic (18D) and they are genuinely passionate about their work.

Their hemostatic products are just one of 4+ items their bringing out.

Their tourniquets are also badass and deploy faster than the CAT or SOF tqs. If you fb you can follow them at:

https://www.facebook.com/activmed

Galaxy Note II + Tapatalk 2
Sucks that they dont have a normal webpage

[davsel]

A Recee once told me they used tampons for bullet wounds. Perfect size, built in applicator, sterile, cheap, easy to carry, designed to expand and absorb blood. Makes sense to me.

[Mick-Boy]

That's straight out of 70s. There are better options out there for hemorrhage control.

[osok-308]

I've got you covered.


http://www.youtube.com/watch?v=nh6_bNNUpIo

You read me like a book!

[Mick-Boy]

http://www.rxlist.com/script/main/art.asp?articlekey=177751

Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

According to the U.S. Army Medical Department, Medical Research and Materiel Command, since mid-World War II, nearly 50 percent of combat deaths have been due to exsanguinating hemorrhage (bleeding out). Of those, half could likely have been saved if timely, appropriate care had been available.

The device consists of three, syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, after approximately 20 seconds upon contact with water from blood or bodily fluid. This creates a temporary physical barrier to blood flow. The number of sponges needed for effective hemorrhage control will vary depending on the size and depth of the wound. Up to three applicators may be used on a patient. The tablet-shaped sponges are each 9.8 millimeters in diameter and 4 to 5 millimeters in height. They can absorb 3 milliliters of blood or body fluid. An applicator filled with 92 sponges, therefore, can absorb about 300 milliliters of fluid.

The sponges cannot be absorbed by the body and all sponges must be removed from the body before a wound is closed. For ease of visualization and to confirm removal of every sponge, each sponge contains a marker visible via X-ray.

"XSTAT is a novel device that can be rapidly deployed, providing fast-acting hemorrhage control to stabilize a wounded patient for transport," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "This will be an important new treatment option for our nation's military to treat injured soldiers who may not be in close proximity to a medical facility."

The FDA reviewed XSTAT through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.

The FDA's review of the XSTAT submission included animal studies demonstrating its effectiveness at stopping bleeding and the absorption capacity of the device. In addition, non-clinical biocompatibility data and human factors testing were provided to demonstrate the safety and usability of the device.

The XSTAT is manufactured by RevMedX, Inc., in Wilsonville, Ore.

SOURCE:

FDA

[cofi]

Sweet any idea on when we can buy em?

[Flatline]

This product doesn't make sense to me. I can only imagine how pissed a trauma surgeon is going to be when he has to pick out anywhere from 1 to 92 little pieces of gauze. I also don't know why you would unpack a wound in the field that is actively bleeding, pack the wound and apply pressure. If the pressure would harm anything, then that cavity is probably fill with blood anyway. I like an applicator for 1 gauze sponge that has clotting agents, but 92 pieces to fish out is going to suck.

[hurley842002]

I can only imagine how pissed a trauma surgeon is going to be when he has to pick out anywhere from 1 to 92 little pieces of gauze.

I can only imagine that I don't really care how pissed a trauma surgeon gets, if those 92 little pieces of gauze save my ass.....

[Flatline]

I can only imagine that I don't really care how pissed a trauma surgeon gets, if those 92 little pieces of gauze save my ass.....

Minor detail, this is considered an invasive procedure. Guess who approves the interventions performed by paramedics in the US. Guess who approves what the army medics carry and use. Spoiler, its a physician.


The concensus from the revmed guys is that it's easier to get the sponges out than to debride a bunch of quick clot powder or gauze out of a wpund.

Galaxy Note II + Tapatalk 2

You mean the guys selling the product say its better than the competitors product?!?

[Mick-Boy]

Who the hell still uses quick clot powder (granules)? I haven't seen any of that stuff since Iraq in '07 or so.

Like I said back in Feb. I'd be very interested in seeing 3rd party testing. I'm going to try and get our TCCC guys to get their hands on some of this for our next pig lab too. The proof is usually in the pudding, not the press releases and advertising.

[hurley842002]

Minor detail, this is considered an invasive procedure. Guess who approves the interventions performed by paramedics in the US. Guess who approves what the army medics carry and use. Spoiler, its a physician.



You mean the guys selling the product say its better than the competitors product?!?

Kind of contradicting the physicians "frustrations" aren't you?

[cmailliard]

Who the hell still uses quick clot powder (granules)? I haven't seen any of that stuff since Iraq in '07 or so.

Like I said back in Feb. I'd be very interested in seeing 3rd party testing. I'm going to try and get our TCCC guys to get their hands on some of this for our next pig lab too. The proof is usually in the pudding, not the press releases and advertising.

I'm still in this boat as well. To me nothing is good until it has solid third party testing. Marketing, advertising and the FDA approval are one thing but until USAISR gets their hands on it and tests it against Combat Gauze I will remain cautiously optimistic. Other than company testing I have not seen any quantitative or qualitative research on this product. I am not against this product at all I am just not convinced yet.

Trauma Surgeons can pound sand, the patient is alive on your table, not dead in a ditch. I told a trauma doc at a local Level 1 the same thing about 8 years ago.

[cofi]

Who the hell still uses quick clot powder (granules)? I haven't seen any of that stuff since Iraq in '07 or so.

Like I said back in Feb. I'd be very interested in seeing 3rd party testing. I'm going to try and get our TCCC guys to get their hands on some of this for our next pig lab too. The proof is usually in the pudding, not the press releases and advertising.


Your so lucky I would love to do live tissue training

[Flatline]

How about bringing something to this discussion other than sarcasm?

I bring unbiased experience. People can say that they don't care what the surgeon thinks if they get there alive, but if 80% of your patients die on the table instead of 25% due to the increased time taken in surgery (pulling out 92 pellets is going to take a long time, and if you have to explore or take xrays because you don't really know how many pellets there are it will take even longer), but you only increase the number of causalities that make it to the OR by 10% is it worth it (obviously these stats are made up, but without studies nobody will know what they really are)? Pressure dressings or other traditional methods not only stop blood from exiting the body, but will prevent third spacing of the blood into organ cavities, can this product work as well or does it only stop blood from exiting the wound tract? I have seen many triple As die from hemorrhagic shock with all of the blood being third spaced in the peritoneal cavity.

People want to jump on a bandwagon because something is new and exciting. This could potentially be a good product, but it could also be crap. I would love for this to be great, but for the reasons above I have my doubts. All medical professionals should recognize this, and not advocate for something until there is efficacy (as proven by multiple third party studies). I see the same thing in the fire service, some company will try to peddle their new product without any proof that it works any better than what we already have. They usually have some flashy video of them putting out a mobile home fire is 30 seconds on their website, but struggle to show it works any better when we ask them to do it at our station. The company is there to make money.

I would love a tool that can increase survivability be it this product or any other, but there needs to be proof.

Why are you so defensive when someone has doubts about an unproven product?

[ChunkyMonkey]

I bring unbiased experience. People can say that they don't care what the surgeon thinks if they get there alive, but if 80% of your patients die on the table instead of 25% due to the increased time taken in surgery (pulling out 92 pellets is going to take a long time, and if you have to explore or take xrays because you don't really know how many pellets there are it will take even longer), but you only increase the number of causalities that make it to the OR by 10% is it worth it (obviously these stats are made up, but without studies nobody will know what they really are)? Pressure dressings or other traditional methods not only stop blood from exiting the body, but will prevent third spacing of the blood into organ cavities, can this product work as well or does it only stop blood from exiting the wound tract? I have seen many triple As die from hemorrhagic shock with all of the blood being third spaced in the peritoneal cavity.

People want to jump on a bandwagon because something is new and exciting. This could potentially be a good product, but it could also be crap. I would love for this to be great, but for the reasons above I have my doubts. All medical professionals should recognize this, and not advocate for something until there is efficacy (as proven by multiple third party studies). I see the same thing in the fire service, some company will try to peddle their new product without any proof that it works any better than what we already have. They usually have some flashy video of them putting out a mobile home fire is 30 seconds on their website, but struggle to show it works any better when we ask them to do it at our station. The company is there to make money.

I would love a tool that can increase survivability be it this product or any other, but there needs to be proof.

Why are you so defensive when someone has doubts about an unproven product?

Its one thing to show skeptism. Another just to be a smartass.

Like mentioned above, the product is being or will be tested. Most of the above posters are folks who have been in the industry, medic, trainer and even on the battlefield. Their words mean so much more than yours since I dont know you personally.

Unless you are a surgeon, I dont think you can speak beyond just your own personal opinion.

[Flatline]

Its one thing to show skeptism. Another just to be a smartass.

Like mentioned above, the product is being or will be tested. Most of the above posters are folks who have been in the industry, medic, trainer and even on the battlefield. Their words mean so much more than yours since I dont know you personally.

Unless you are a surgeon, I dont think you can speak beyond just your own personal opinion.

How about a Paramedic/RN who also has a BS in biology, though not a surgeon I feel that my experience might be worth something. My "smartass" comment was only in response to what people said after my first post, who didn't find any value in an opinion that did not support the product.

[Flatline]

Unproven you say, so you know exactly how this products been fielded and tested? Apparently you don't even know how the CoTCCC is structured, much less the FDA process that the product has been subjected to. I don't own stock, don't care beyond wanting to see the good guys get the best product possible be they mil, civ or LE.

Having met the inventor, seen the lab testing video and hearing some of the field trials from downrange, I'd say you weren't offering an unbiased opinion, so much as an uninformed opinion.

I want everybody to have a good product, especially me. Until its proven I can't advocate for something being the "best product." If they don't publish it, then I don't have access. If you would like to share this information I would love to look at it. Most companies publish their studies, I could not find anything other than new stories announcing this company presenting the product. All I see is a bunch of hype with nothing backing it with makes me instantly suspicious.

[Mick-Boy]

The blood leaking into the space in between the organs that Flatline mentioned is a huge issue with controlling bleeds in the pelvic or shoulder girdles. I've seen guys stuff hundreds of 4x4s into a pig and not stop the bleeding (almost two of these (http://www.amazon.com/Dynarex-Non-Sterile-Gauze-Sponge-Count/dp/B0006GDACS/ref=pd_sim_hpc_6?ie=UTF8&refRID=0592BPF7B9FAA79F4GEF) because they weren't on the bleed. Maybe little sponges will work better than z-folded combat gauze (which is the standard right now). But it takes serious third party testing to validate that. Manufacturers claims don't mean much in most cases. They're in the business of making money. Of course they claim their product is the tops.

[stodg73]

Any new information on this product?

[HoneyBadger]

Thread bump! This product received FDA approval for civilian mass-marketing in December 2015. Sweet!

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm475810.htm

[GilpinGuy]

Instant EDC item. Nice.

[cmailliard]

Approved for civilians, but is still a Class II Rx Only device, meaning you must have a prescription for it. It is only designed for EMS and hospital use only right now.

[HoneyBadger]

Approved for civilians, but is still a Class II Rx Only device, meaning you must have a prescription for it. It is only designed for EMS and hospital use only right now.
Oh, bummer. I missed that part.


So... who here can write me a prescription for one? ;)

[Irving]

Write me a prescription too please. I have chronic bullet pain.

[HoneyBadger]

Write me a prescription too please. I have chronic bullet pain.
This doesn't help pain. You'd have better luck getting a prescription to stop that annoying monthly bleeding you have. ;)

[GilpinGuy]

Approved for civilians, but is still a Class II Rx Only device, meaning you must have a prescription for it. It is only designed for EMS and hospital use only right now.

Fuckin government. God forbid we save ourselves.

[HoneyBadger]

Fuckin government. God forbid we save ourselves.
But, but, but.... you don't know what's best for yourself!! You can't be trusted to make decisions about your own body!! [panic]

[cmailliard]

Fuckin government. God forbid we save ourselves.

Yeah, part of it, or actually most of it, is because this is designed to go into the body. All the way from original QuickClot to Combat Gauze everything says "external use only". There is a distinction in the eyes of the FDA for something that goes in the body i.e. angiocaths for starting an IV or a monster one for a needle decompression. For invasive procedures they like a physician to have some oversight on that which is why Rx Only.

All that being said the only any hemostatic works is by applying at the point of injury, the artery, IN the body. If Combat Gauze had been released in a different manner stating "apply to injured artery" it too may very well have had a Class II Rx Only designation.

[HoneyBadger]

We need to recognize that products like this (and quickclot, combat gauze, etc) are not a permanent solution to a severed artery - They are just meant to keep you alive long enough to get to a real surgeon.

[GilpinGuy]

Yeah, part of it, or actually most of it, is because this is designed to go into the body. All the way from original QuickClot to Combat Gauze everything says "external use only". There is a distinction in the eyes of the FDA for something that goes in the body i.e. angiocaths for starting an IV or a monster one for a needle decompression. For invasive procedures they like a physician to have some oversight on that which is why Rx Only.

All that being said the only any hemostatic works is by applying at the point of injury, the artery, IN the body. If Combat Gauze had been released in a different manner stating "apply to injured artery" it too may very well have had a Class II Rx Only designation.

Ok, fuck the FDA then. If I'm bleeding to death I really don't give shit what the FDA would like....I'd like to continue living my life without some beaurocrat deciding if I have the authority to treat myself or not. Or my wife or kids or some innocent victim I came across.

I'm not bitching at you, just the insanity that is the government.

Do they regulate dildos? They go in the body as well.[Sarcasm2]

[HoneyBadger]

Do they regulate dildos? They go in the body as well.[Sarcasm2]
I would love to see a legal challenge along these grounds [LOL]

[Bmac]

Do they regulate dildos? They go in the body as well.[Sarcasm2][/QUOTE]


LOL!!!![Beer] Apparently not, as I run into them daily in my travels,,,, wait, that might just be me in disquise!