New mountain lion after bite care device, $65

[David Corbin]

From http://medgadget.com
video at http://tinyurl.com/7egjt32

Tactical Use Skin Closure Device Stops Traumatic Bleeding in Combat Zones
by SCOTT JUNG on Apr 5, 2012 • 2:26 pm

Bleeding is the single largest cause of preventable trauma death, and when our armed forces are out in the combat zone, stopping a bleeding wound can be difficult. Dr. Dennis Filips, a retired trauma surgeon from the Canadian Navy and CEO of Edmonton, AB-based Innovative Trauma Care, saw a lot of bleeding while serving in Afghanistan, and wondered if there could be a way to reduce the mortality rate from traumatic hemorrhage other than using tourniquets and hemostatic wound agents, which take time to apply.

Inspired by a simple hair clip, Filips designed a device called the Tactical Use Skin Closure (TUSC) device. The TUSC is essentially a sterile, plastic clamp approximately five centimeters in length, with curved needles along the “jaws” of the device. In a trauma situation, the responder clamps the device along the wound. The curved needles and the shape of the TUSC draw the wound up into the device and anchor it with even pressure, allowing the blood underneath to create a clot around the wound and help stop the bleeding until the victim receives further medical attention.

The TUSC can be applied in a matter of seconds and can used by basically anyone with minimal training. The device only costs about $65, so it’s affordable for military units, hospitals, and paramedics anywhere.

http://www.innovativetraumacare.com/index.php?option=com_content&view=article&id=46&Itemid=53

[Kier Selinsky]

I'm not seeing the advantage here. If you get a deep puncture/incision that severs an artery, you must do a tourniquet, because simply sealing up the skin wouldn't stop the bleeding, just let it pool inside you. If you get a skin or muscle-deep slash, elevation and pressure is all that's needed for first aid, and can even hold you over for a couple days in the backcountry if needed. I just don't see what this device adds, albeit for a super remote possibility.

[Alex Gilman]

Brilliant! If a mountain lion attacks you, you won't see it and it will probably maul your throat. Even if it were scared away this stupid modified hair clip won't fix your severed artery.

May as well man up and take a staple gun and some super glue with you.

[Doug Smith]

I try to stay open to new ideas, but I agree, I just don't see the effectiveness of this devise. I've been an EMT for 16 years (4 of which were as a SWAT medic). When I went through Advanced Tactical Medicine school we were taught that after extensive testing (primarily by the USN SEALs using live swine), Combat Gauze was the only hemostatic agent found to have any significant improvement in bleeding control over a standard pressure dressing.

http://www.narescue.com/portal.aspx?CN=C988281412A7

Combat Gauze is a hemostatic agent (a new version of Quik Clot that does not cause exothermic reactions) impregnated in gauze. You can stuff the wound, then wrap it as a pressure dressing. A tourniquet is effective, but obviously only on extremity wounds.

In my "blow out kit" that goes with me in the car, at work, hiking, and motorcycling, I carry a Combat Gauze pack, SOFT-T tourniquet, and triangle bandage. Those three things will bandage a wide variety of boo-boos. The wrapper for the Combat Gauze can be used as an occlusive dressing for sucking chest wounds.

My little first aid kit that complements it has things such as Iodine, bandaids, ibuprofin and benadryl. For my dog, about the only thing I add is hydrogen peroxide incase they eat something they shouldn't have.

Anecdotal story…I walked up on a mountain lion at work one night while hiking in a ravine. He was about 25 feet away from me when we saw each other. I felt very under-armed, with only my Glock pistol (the rifle was back in my car). Luckily, he walked one way and I walked the other. ;-)

[Jeff LaVista]

In my mind, just about everyone would be much better served by carrying a triangular bandage or two. Use one as a shemagh, headwrap, pre-filter, bandana or whatever for some multi use purposes. Keep the second one sterile for packing or wrapping directly onto a bad wound, using the second non-sterile over it if needed (that and then any other improvised bandages necessary to stop the bleeding).

Beyond that, they can be used to fashion splints, slings, head bandage, stabilize an ankle, or the material used in strips for who knows what non medical purposes like gear repairs

[Daniel Cox]

Ok, I get the theory behind it, but I can only see the use for slicing wounds, where wound margin approximation is neat and clean. Mountain lion wounds would not be neat clean slices. They are gaping ragged holes. Just like IED wounds and blast injuries. At least everyone that I saw in 3 tours in the middle east as a light infantry medic was. Shame on the inventor for not recognizing proper wound care.

Edit: This thing doesn't do anything that proper direct pressure can't. And I bet the ER doc is gonna love trying to remove that thing after it's been in place for a while.

[David Drake]

Mountain lions aren't enemy soldiers or criminals. The backcountry isn't a combat zone. Anyone who thinks it is should probably stay home. Plus maybe do a little research into the actual number of animal attacks every year, their causes and avoidances.

[Roger Caffin]

Reckon a roll of 3M Micropore tape would be far more useful. I have used that to close a large deep slash wound close to 80 mm long. Very successful too.
Made it to the hospital with the tape on: they replaced the tape with about 30 stitches.

Cheers

[Bob Gross]

Roger doesn't need this device for mountain lion bites. He probably needs a different one for drop bear bites, and it will cost twice as much.

–B.G.–

[Doug Smith]

"Mountain lions aren't enemy soldiers or criminals. The backcountry isn't a combat zone. Anyone who thinks it is should probably stay home. Plus maybe do a little research into the actual number of animal attacks every year, their causes and avoidances."

You're welcome to your opinion David. Wound care is cound care. Regardless of where it comes from. The mechanism of injury may be different but the treatment remains the same for the most part. This thread isn't about the incidence of animal attacks in the wilderness. It's about the treatment of them when they do occur. How is your post relevant to the discussion?

If I'd mentioned that 13 years of my EMT time has included being a medic on a wilderness SAR team would that seem less "combat" oriented to you? Banking on the fact that you'll never be attacked by an animal is a dangerous mindset. The wilderness can provide injury in a great many ways. Implying that people shouldn't prepare for treating injuries is poor advice.

[David Drake]

Apologies for the overly-aggressive tone of my post.

I should have echoed the thoughts of others up-thread: this device adds nothing to the combination of knowledge and equipment lightweight backpackers have developed for injury treatment and prevention, under rationally foreseeable circumstances.

[Doug Smith]

I appreciate the apology David, and I agree with your last post. I was too blunt in my repsonse and also apologize. I try to remember to wait for a while when responding so that I write in a more casual tone, but as you see that doesn't always happen. ;-)

[steven franchuk]

From the website

"It can also be used in conjunction with tourniquets and hemostatic agents to increase their efficacy. Whereas tourniquets can take 3-5 minutes to apply and hemostatic agents require an additional 3-5 minutes of pressure once they have been properly applied, the TUSC can be applied within seconds of wounding."

The issue is time if you are bleading heavily you need to stop the bleeding before you loose too much. A clotting agent may take minutes to work while this device can fully stop or greatly slow blood lose in seconds.

"I'm not seeing the advantage here. If you get a deep puncture/incision that severs an artery, you must do a tourniquet, because simply sealing up the skin wouldn't stop the bleeding, just let it pool inside you."

Kier, blood pooling between the skin and artery is not serious. Once the blood starts pooling the pressure on both side of the artery is equalized and bleeding stops. The pooled blood will then clot and the artery will start healing. The pooled blood and clot will then over time be absorbed by the body.

Once a tourniquet is applied it must be eventually loosened or removed to prevent the loss of the limb due to lack of blood flow. Furthermore the artery cannot heal without blood flow. Unfortunately Loosening the tourniquet could result in additional blood loss. This device when use with a tourniquet would allow the removal of the tourniquet earlier with little to no risk of additional blood loss.

[Dustin Short]

I still think the issue is this being proposed for mountain lion wounds.

For the most part, humans are larger than lions and they don't hunt us. In some rare circumstances, whether small adults and children, they will attack humans.

The problem is their hunting technique, they stalk behind their prey and when close enough leap onto the back and crush the neck or skull. So injuries tend o consist of either minor lacerataions, or death. Not much in between that would be life threatening. Also most attacks, statistically speaking, seem to occur near civilization on high traffic trails rather than in the backcountry where treatment is more problematic. This may be due to both higher traffic, and weaker or older animals pushed to the fringes of lion territories where less animal game is available (hunger desperation becomes a factor), but granted this is just highly reasoned speculation on my part.

Also why is there all this fear over deep life threatening lacerations? Painful and bloody cuts, sure those can happen, but I rarely see injury reports of "hiker bled to death…" From the very nature of hiking, unless a long fall is involved, it's pretty hard to suffer these types of wounds. If a fall is involved, well then you'll probably have broken bones and internal bleeding to complicate survival anyway where staying calm and improvisation will save your life more than any first aid kit.

There just seems to be a mentality of how to treat an accident and little care of how to prevent an accident.

[Ken Thompson]

"There just seems to be a mentality of how to treat an accident and little care of how to prevent an accident."

+1 Some have forgotten the principal of mindfulness. Don't go through life with constant reckless abandon. Think before you do…

Oh and you're the snake bite kit guy from last year. It's not that scary outside.

[John S.]

Troll bait.

[Ted E]

like some of the other guys stated above, i bring quick clot with me on my trips along with a very small first aid kit. the quick clot + compression wrap made from clothing should take care of any large wound unless its so big im going to bleed to death internally, in which case im probably screwed. i don't think this device would help any better than quick clot.

[Kier Selinsky]

>>"Kier, blood pooling between the skin and artery is not serious. Once the blood starts pooling the pressure on both side of the artery is equalized and bleeding stops. The pooled blood will then clot and the artery will start healing. The pooled blood and clot will then over time be absorbed by the body."

An artery bleeding out, whether contained by your skin or not, is a serious serious issue. Pooled blood, in the quantities you get from an artery, doesn't clot very quickly, think days. The tourniquet should be loosened by the docs in the ER and no one else. Blood pooled in your skin, outside of your circulatory system, is still considered blood loss. It does you no good there.

You can and will die from an arterial eruption even if contained by your skin – it's internal bleeding. Much better to lose an arm to a tourniquet after a few days than to die from internal bleeding. I have very personal experience with the dangers of internal bleeding.

[Ian Joseph Atkinson]

Just to state my bias up front – I an one of the co-founders of Innovative Trauma Care (780-638-2485). The device is not yet cleared for sale in the US or Canada.
-As per use of the ITClamp in austere environments such as the back country, it is intended to manage wounds in compressible zones, such as the arms, legs, junctions (groin, armpits, base of the neck), and scalp/face. Although it wouldn't manage internal bleeding in the chest or abdomen, it could seal a sucking chest wound or an evisceration until transport.
-The device seals the skin to form a temporary pool of blood (hematoma), and back pressure would form in the cavity (tamponade) to reduce additional blood loss. For a large cavity wound, packing with a hemostatic dressing and then applying the ITClamp would make both devices more effective.
– We believe the device could be used for puncture wounds from accidents of all types, such as trees, knives, saws, etc. As per a mountain lion bite, there are better solutions such as tourniquets available for amputations or large sections with skin removal. For large or irregular wound margins, more than one device can be used in series to pull skin edges together (1oz per device).
-Due to it's simplicity, it could allow for self-aid or buddy-aid (or for working animals), as a rapid temporary fix for a few hours to get to definitive care.

[David Corbin]

Although this device is not approved by the U.S. Food and Drug Administration (FDA), it might be possible to import it under an amendment to the Food, Drug, and Cosmetic Act (FD&CA).

This amendment provides a means by which individuals can import a prescription drug or device which is not approved by the FDA. The fact that the FDA may, in its discretion, may allow such importation does not legalize the drug or device.

As a practical matter, an individual in the U.S. would need a willing medical practitioner to write a prescription and there would have to be some form of documentation, such as the results of a Phase I clinical trial, explaining why the device "does not appear to present an unreasonable risk to the individual."

Although the FDA's Regulatory Procedures Manual (RPM) (see below) states that the exercise of its discretion is applicable to "a serious condition for which effective treatment may not be available domestically," the RPM is a "policy" rather than a "regulation," and the FDA enjoys virtually unfettered discretion on what unapproved drugs and devices it may allow individuals to import.

In real life, thousands and thousands of unapproved drugs and devices are imported daily, mainly be persons arriving abroad with such items in their baggage.

Reference:

21 U.S.C. § 384 (j) Waiver authority for importation by individuals

(1) Declarations
Congress declares that in the enforcement against individuals
of the prohibition of importation of prescription drugs and
devices, the Secretary should –

(A) focus enforcement on cases in which the importation by an
individual poses a significant threat to public health; and

(B) exercise discretion to permit individuals to make such
importations in circumstances in which –

(i) the importation is clearly for personal use; and

(ii) the prescription drug or device imported does not
appear to present an unreasonable risk to the individual.

(2) Waiver authority

(A) In general
The Secretary may grant to individuals, by regulation or on a
case-by-case basis, a waiver of the prohibition of importation
of a prescription drug or device or class of prescription drugs
or devices, under such conditions as the Secretary determines
to be appropriate.

(B) Guidance on case-by-case waivers
The Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in which the
Secretary will consistently grant waivers on a case-by-case
basis under subparagraph (A), so that individuals may know with
the greatest practicable degree of certainty whether a
particular importation for personal use will be permitted.

========================================================

In implementing 21 U.S.C. § 384 (j), the FDA's Regulatory Procedures Manual (RPM) (2011), Chapter 9, Import Operations and Actions, § 9-2, Coverage of Personal Importations, page 9-14 through page 9-15, states:

In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:

* * * *
2) a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;

b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;

c) the product is considered not to represent an unreasonable risk; and

d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

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