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MEDICAL DEVICE AUTHORIZATION NOTICE: Federal (USA) law restricts this device to sale by or on the order of a practitioner licensed to use or order the use of this device. Purchase of this medical device requires that the user have supervision from a licensed medical practitioner. Devices requiring such supervision may be labeled “Caution” or “RX only”. Ensuring this supervision is the purchaser’s responsibility and the purchaser must acknowledge and accept the terms of this notice prior to sale. Authorization from a medical profession may be requested prior to the fulfillment of this item.
For over two years, H&H Medical worked on an improved method for performing a needle decompression. This work with TyTek Medical resulted in the creation of the PneumoDart. Based on a patented design, the PneumoDart consists of a hollow, closed-end stylet, spring-loaded safety tip housing a 14 gauge interior diameter catheter that is 8.6cm in length.
The needle housing comes color indicator showing when the safety tip retracts, the PneumoDart is designed to stay in place. The cap is also a luer connector to allow for the rapid removal of air using a manual suction device (e.g. syringe) or the clearing of fluids from the needle (not recommended for use with a hemothorax).
The TyTek PneumoDart was designed to overcome the shortfalls of the flexible catheter. The catheter was never designed for this purpose and as an IV catheter, it is designed to become soft and pliable in the body. This fact makes it only a very temporary solution for tension pneumothorax, one which will fail shortly after insertion as we have seen many times on the battlefield requiring multiple needles with an increase in misplacement and damage to the tissues.
Placement verification of the flexible catheter in the chest could not truly be delineated as there is no indicator other than the potential audible rush of air. On the ground, in the air, or in combat this is very difficult to appreciate. Even when one is successful, there is no indicator to show placement and to ensure proper depth to maintain for continuous venting of the pneumothorax.
We designed our product along with a similar design of a Veress needle used in the operating room for laparoscopic procedures. If you google a Veress needle, you will see the inner cannula retracts to expose the needle. The needle inserts through the tissue and deploys the blunt tip cannula once the needle is through. Our needle has a blue plastic indicator that moves up and down with the cannula.
Once our needle penetrates, the cannula will deploy and the blue indicator will click in the down position to show the operator that they are in the pleural cavity. Now the needle can be secured in place at the proper depth for transport. The needle will not collapse as is the case in the flexible catheter and there is no need to remove the needle until the patient is received in a higher level of care and definitive treatment is delivered.
TyTek PneumoDart Product Information