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Old 01-16-2013, 11:56   #1
98G
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Junctional Hemorrhage

Thanks Richard and Team Sergeant for permission to post this product announcement. I run R&D for our company and we just shipped our first Junctional Emergency Treatment Tool (JETT) having achieved our FDA 510(K) Clearance. We have, in partnership with the University of Texas,conducting research into the the best methods to address junctional hemorrhage.

Junctional Hemorrhage is the new leading cause of preventable combat death.

The successful and aggressive use of tourniquets on the battlefield and the absence of optimized tools to address inguinal injury has recently shifted the focus of the #1 cause of preventable combat death from extremity bleeding to junctional hemorrhaging. Recent data indicates that high extremity wounds in the thigh/groin accounts for up to 20% of preventable combat deaths on the modern battlefield. Over the past two years the military has been working in conjunction with the medical device industry to develop mechanical and pneumatic devices that provide new treatment options for this kind of injury. While these efforts have been promising, the recent rise in bilateral amputations from IED blasts in theatre imposes even greater demands on point of wounding care.

This new “Signature Wound” - two legs blown off at the knee or higher, accompanied by damage to the groin and pelvic region - requires treatment beyond the capabilities of the traditional tourniquet. Injury to the femoral artery demands immediate attention if a casualty has any hope of survival.

The movie, “Black Hawk Down” based on the battle in Mogadishu, Somalia in 1993 depicted the account of CPL Jamie Smith, who was shot in the upper thigh and suffered a severed femoral artery and vein from a bullet. The wound was too high for a tourniquet and other attempts to control the bleeding were not successful. The medic attempted a blunt dissection in order to gain access to the blood vessel and clamp the artery. Unfortunately, the artery had retracted into the pelvic region and bleeding continued without any available interventions, resulting in the death of CPL Jamie Smith later that night.

The above example (the event not the film) was one of the catalysts for research into new technologies to save our warriors lives. The original focus was to address the lack of an effective tourniquet. Junctional hemorrhage was a bigger challenge. Over the last two years companies have been working in conjunction with the military to develop mechanical and pneumatic devices that address Junctional hemorrhaging. While these efforts have been successful at providing new options to medical providers, there is great room for improvement.

Pneumatic devices have been demonstrated to be problematic in the military prehospital environment (point of injury) for a variety of reasons but most notable is the challenge of the effect that changing atmospheric pressure has on the air bladder as the patient is moved from mountaintops by helicopters (filled in a low pressure atmosphere and moved to a high pressure atmosphere, the bladder may contract and reduce pressure on the injury–allowing bleeding to reoccur). Any pneumatic device will require constant monitoring to ensure that the proper pressure is maintained and will need to be extremely ruggedized to survive the battlefield. These are some of the reasons why tactical providers prefer a mechanical device on the battlefield.

We designed our "JETT" with the capability of treating bilateral injuries, be easily applied, withstand the rigors of the tactical environment and provide a compact, lightweight solution to junctional hemorrhage. We have taken into account that a casualty will likely require several movements before they reach a fixed medical facility. Therefore, the JETT employs a circumferential buttocks pad (secures the device to the patient), two pressure pads (allows for individual or bilateral activation, based on the patients injuries) and locking devices (ensures that vibrations or bumps to the windlass will not reduce the pressure during movement).

  • Compact, lightweight & ruggedized for use in the tactical environment
  • Pre-assembled, Ready-to-use & Easy-to-apply at or near the point of injury
  • Simultaneous Occlusion of blood flow to both lower limbs that does not impede Respiration
  • 2 Compression Pads, pre-positioned and individually adjustable, allow for individual or bilateral activation, based on the patient’s injuries. Note: When we conducted our studies the shape we designed (Trapezoidal) is more stable and fits into the inguinal crease better
  • Cleared for 510(k) by the FDA


http://www.medgadget.com/2013/01/jet...do-wvideo.html


Stay Safe.
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Old 01-16-2013, 15:20   #2
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Welcome back to an old device called "Otto Clotto", a C-clamp style device we used on the heart surgical service when removing an intraaortic balloon pump or ventricular assist device cannula in the femoral artery.
Seems like a high profile but not having it in my hand I can't exactly tell. The concept of truncal or axial bleeding ( junctional is a new term someone dreamed up recently) control is not new and the idea of using combat gauze/packing and direct manual pressure isn't new just difficult when you need your hands for other things like defending yourself. Having a self retaining device to hold pressure has a place but I'm going to guess that the placement of his isn't common sense and requires significant training, ie the average soldier will not be adequately trained to appropriately apply this device.
Why have we not brought back the pelvic component of the MAST suit which anyone can apply and inflate, just put one or two gel pads in the anatomically correct position over the femoral area and inflate the MAST and You get compression of superficial and common femoral arteries.
Seems like the Jett should work but field trials will tell the whole story, sorry but I'm skeptical. Will wait to see what medical literature and field use show until I would endorse this device........being a trauma surgeon and SWAT tactical medical provider I would use something like this except I won't at the point of injury but might in a warm zone where I would have left my bigger pack with secondary resources and equipment.
Good luck and keep us informed

Ss

Forgot to add: need to spell hemorrhage correctly
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Last edited by swatsurgeon; 01-16-2013 at 15:29.
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Old 01-16-2013, 17:40   #3
98G
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Hemorrhage

OK TS need your help!

Typer's Dyslexia struck -- I can't seem to edit the thread or post title. Any chance you can? One m, 2 r's. Hemorrhage hemorrhage hemorrhage!


Swatsurgeon, you might take a look at the video application. It has been easy to train so far and is certainly trainable for a 68W and we are testing for a combat lifesaver. 18D's mastered it pretty fast at Bragg before we trained them. (Then they read the instructions.)

Pneumatic solutions (like MAST trousers) don't really work well in military CASEVAC as I mentioned in my earlier post.

A standard C clamp solution can work if a casualty is not moving or being moved.

The sad part of the usage is that it is the result of another serious injury. I hope that it takes awhile to collect the data to do the studies of its use in action. Studies of it in simulation are available within DoD and some in training will be published shortly.

But for those deploying or deployed already, we are shipping as fast as we can.
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Old 01-16-2013, 20:16   #4
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Put my hands on the prototype this past year. I was impressed with its stability, ease of use, relative size/portability, and the small amount of pressure required to silence the doppler.

Glad to see it has finally made its way through the final steps needed to get it in the field where it will make a difference.

I will take another look at it when I get back home...
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Old 01-17-2013, 00:30   #5
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First off, thank you for your urgency in addressing what you see is a serious problem with regards to our combat wounded.

Just a few weeks ago one of our commanders came by and mentioned this device - both myself and one of our experienced (read: old) trauma nurses looked at each other and laughed.... and immediately thought about the MAST trousers that SWATSURGEON mentioned. The more things change, the more they stay the same....

Has your concern about pneumatic devices during helicopter transport ever been borne out in real life? Back when MAST trousers were popular did anyone notice people exsanguinating during helicopter rides?

Let's play with the concept behind Boyle's Law for a minute (OK all you DMTs, follow along <g>) - lets say a pneumatic device is applied to stop bleeding at 3000ft elevation (91 kPA air pressure). Helicopter then ascends to 8000ft to deliver casualty, at which elevation the air pressure is approx 75 kPA. You are talking about an 18% change in notional volume during that shift - or using old geometry formulas (Vol of sphere = 4/3 pi r^3) the diameter difference between those 2 containers is less than 8%! - which would result in a negligible change in the amount of pressure that was being applied to the artery (which is what we really care about).

Furthermore, whatever material you make your pneumatic device out of is NOT an ideal material - it has elastic properties that means some of the force caused by the pressure difference will NOT be reflected as a change in volume - the same reason an elastic balloon contains air under higher pressure than the air that surrounds it.

Anyway, I'm not a materials scientist, I'm just a manual laborer who really liked all the DMT stuff... My REAL criticism about pieces of equipment like this dates back to lessons hammered into me during the 18D course...

You are asking guys to tote along a bulky piece of equipment that has only one use. What are they going to have to leave behind due to this piece of equipment? Will they carry fewer Combat Gauzes or bags of hetastarch? Fewer bullets? If so, how often does this "Junctional Hemorrhage" occur? Yes, I saw the movie along with everyone else, and had nightmares about that injury just like every other 18D... but I question whether adding another piece of bulky equipment to the medical set is the answer. It doesn't matter whether we're talking about an Aid Bag being carried, or a foot locker on a MRAP, there are still strict limitations on the amount of stuff guys can drag along with them, and we cannot always justify giving them more things to carry - and it's harder to justify it when the piece of equipment we are asking them to carry will only do ONE TASK... and that one task happens very very rarely.

I hate to quash the obvious enthusiasm you have for your piece of equipment, but a "one-trick pony" piece of gear is gonna be a hard sell.

Sorry I can't watch your video (crappy bandwidth where I'm at), but I've seen just as many videos of Quick Clot or Combat Gauze stop bleeding from a transected femoral artery in a swine model, and done it myself quite a few times (again, swine & caprines only, thankfully) to know it may not work 100% of the time, but it works OFTEN, and that is a "piece of gear" that can be used for multiple uses, not just a single one.

(Thanks to Tom Sheridan and the rest of the 300F1 instructors for those great lessons....)
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Old 01-17-2013, 07:31   #6
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I am travelling today so I can't access all the data but yes, there are studies and i will get the references for you all. And the feedback is great. I appreciate it.

As for what goes in the bag -- and what goes out remains as always mission dependent. If there is a vehicle, it would be in the WALK. For cube space to consider:
  • Packaged: H 3.25 in. x W 5.25 in. x D 6.75 in.
  • Weight: 1 lb 9.6 oz

More as soon as I get my WIFI up in the car. (I am not driving.)
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Old 01-17-2013, 07:52   #7
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Quote:
Originally Posted by 98G View Post
I am travelling today so I can't access all the data but yes, there are studies and i will get the references for you all. And the feedback is great. I appreciate it.

As for what goes in the bag -- and what goes out remains as always mission dependent. If there is a vehicle, it would be in the WALK. For cube space to consider:
  • Packaged: H 3.25 in. x W 5.25 in. x D 6.75 in.
  • Weight: 1 lb 9.6 oz

More as soon as I get my WIFI up in the car. (I am not driving.)
Smaller than it appears for sure. I look forward to any info you can share. I am not here to bad mouth/bash or be negative, only to critique and discuss so that multiple opinions from those that understand the anatomy, physics and appication /uses have a chance to offer feedback and criticisms.
Thanks for sharing

ss
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'Revel in action, translate perceptions into instant judgements, and these into actions that are irrevocable, monumentous and dreadful - all this with lightning speed, in conditions of great stress and in an environment of high tension:what is expected of "us" is the impossible, yet we deliver just that.
(adapted from: Sherwin B. Nuland, MD, surgeon and author: The Wisdom of the Body, 1997 )

Education is the anti-ignorance we all need to better treat our patients. ss, 2008.

The blade is so sharp that the incision is perfect. They don't realize they've been cut until they're out of the fight: A Surgeon Warrior. I use a knife to defend life and to save it. ss (aka traumadoc)

Last edited by swatsurgeon; 01-17-2013 at 09:09.
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Old 01-17-2013, 22:35   #8
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And again, let me emphasize, that I appreciate the work and enthusiasm that guys like you put into your products. My skepticism comes from my personal experiences of having to be ruthless with minimizing weight & volume carried.

...as well as a personal philosophy of KISS:

Even if weight and cube are NOT limitations, there is another issue: If you have 100 pieces of gear that each can perform a single task, then you have to find one item amongst a hundred on a shelf (in an emergency, mind you)....

But if each item can do 10 things, it's easier to find the one you need because your shelf isn't so cluttered. The majority of the time, a piece of gear that will do many jobs well is better than a piece of gear that will excell, but only at a single job....

Just my 2 cents.....
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Old 02-27-2014, 00:40   #9
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other options

Recently I completed SOCMSSC and we spent some time discussing the various options for dealing junctional bleeds. Within our group we played with the CroC, JETT,the SAM junctional Tournequet, and one in our group showed us something he improvised.

Among the commercial devices we had the opportunity to play with and discuss the consensus in our group was that the SAM JT was the quickest to deploy and the most versatile, as the belt that it comes with can be used as a pelvic splint and the two inflatable pressure cones can be used anywhere with other bandages to make very effective pressure dressings almost anywhere you need. Once my Med order is filled I will have a SAM JT in all of my truck bags.

the improvised option I saw is simple very cheap and all the items you already have in your aid bag.
-2 TQs (we used SOF-tt)
-1/2 sam splints

-connect the two TQs together to form 1 big TQ ( more if you have a fat PT)
- roll the SAM splint up tightly and wrap it abound the TQ where you need to control the hemorrhage (device is made)
- now use the tourniquets just like if you had an extremity bleed with the SAM becoming a pressure dressing.
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