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A Universal Device for Performing Needle Decompression

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: To develop a device for automating needle decompression to more effectively manage tension pneumothorax on the battlefield. 

DESCRIPTION: Needle decompression is an emergency procedure to relieve tension pneumothorax, a condition wherein air fills the pleural space. Tension pneumothorax may be caused by blunt or penetrating trauma, which were reported in nearly 10% of wounded US personnel in Iraq and Afghanistan [1]. Left untreated, tension pneumothorax increases intrapleural pressure to the point of lung collapse and obstruction of venous return to the heart. The ensuing respiratory failure and cardiovascular collapse lead to death. In the large majority of cases, however, decompression (ultimately performed via chest tube) is the only intervention needed to successfully manage the condition [2]. A number of decompression needles and catheters are available to purchase, including extended length, 8 cm devices. Unfortunately, users continue to perform needle decompression incorrectly, with inaccurate siting noted to be a common error [3, 4]. The incidence of thoracic trauma, lethality of tension pneumothorax, and high failure rate of prehospital chest decompression [5, 6] explain why tension pneumothorax is a significant cause of preventable combat death [7]. Development of an automated battlefield solution for tension pneumothorax that can be used by minimally trained combat medics and promotes both procedural success and avoidance of complications (e.g., inadvertent injury to the lung heart, or great vessels) is of critical importance. 

PHASE I: Phase I will consist of designing schematics and diagrams along with limited testing of a prototype for a minimally-invasive device to automate needle decompression, to include identifying the presence of a pneumothorax, locating the appropriate site for treatment, and performing the procedure. The device will be designed such that necessary steps, from diagnosis to dressing application and preparation for transport, are considered and easy to perform – either facilitated by the novel device or unencumbered by it. Specific emphasis will be placed on usability, materials, and design for the particular challenges of the battlefield environment (to include no or low light, loud conditions, cramped space, extreme environments, etc.) and use by all providers, including combat medics with EMT level training. An argument for the approach chosen, to include recognized open questions in the literature, will be included. The phase will also outline a plan for IACUC or HRPO approval (for phase II animal and/or cadaver testing) and a regulatory path for gaining FDA approval or clearance. 

PHASE II: This phase will consist of further developing the automated needle decompression device demonstrating its utility, and validating the prototype(s) through relevant testing. During the first year, the prototype(s) will be tested in simulated and/or large animal model environments in order to determine their practical viability. The second year will involve refinement and more rigorous testing of the chosen design in human trauma models, such as large animal, human cadaver, or simulation. Testing and refinement will involve the device’s adherence to battlefield constraints; the device must be portable, lightweight (<2 lbs), self-contained, have low power requirements, and be useable by providers with only EMT level training. The phase II commercialization plans should include a regulatory plan for FDA clearance. In addition, the contractor should begin establishing relationships with appropriate commercialization partners (manufacturing, marketing, etc.) to facilitate technology transition. 

PHASE III: The technology developed under this SBIR effort will have applicability to both civilian and military emergency medicine. Phase III will consist of finalizing the device design and delivering manufactured devices (in their final form) for military-relevant testing (e.g. environmental, operational, etc.) and FDA-related testing (e.g. biocompatibility, sterilization, packaging validation, etc.). The device will be functional for use by medics, physician assistants, nurses, and physicians in far forward environments (roles 1 and 2 of care). Phase III will also include developing and finalizing training methods and protocols for the new device. In addition, the regulatory package should be in its final form ready for submission to the FDA, including all relevant test data. 

REFERENCES: 

1: Ivey, K.M., et al., Thoracic injuries in US combat casualties: a 10-year review of Operation Enduring Freedom and Iraqi Freedom. J Trauma Acute Care Surg, 2012. 73(6 Suppl 5): p. S514-9.

2:  Luchette, F.A., et al., Practice Management Guidelines for Prophylactic Antibiotic Use in Tube Thoracostomy for Traumatic Hemopneumothorax: the EAST Practice Management Guidelines Work Group. Eastern Association for Trauma. J Trauma, 2000. 48(4): p. 753-7.

3:  Netto, F.A., et al., Are needle decompressions for tension pneumothoraces being performed appropriately for appropriate indications? Am J Emerg Med, 2008. 26(5): p. 597-602.

4:  Ferrie, E.P., N. Collum, and S. McGovern, The right place in the right space? Awareness of site for needle thoracocentesis. Emerg Med J, 2005. 22(11): p. 788-9.

5:  Aylwin, C.J., et al., Pre-hospital and in-hospital thoracostomy: indications and complications. Ann R Coll Surg Engl, 2008. 90(1): p. 54-7.

6:  Waydhas, C. and S. Sauerland, Pre-hospital pleural decompression and chest tube placement after blunt trauma: A systematic review. Resuscitation, 2007. 72(1): p. 11-25.

7:  Eastridge, B.J., et al., Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg, 2012. 73(6 Suppl 5): p. S431-7.

KEYWORDS: Chest Decompression; Needle Decompression; Needle Thoracostomy; Tension Pneumothorax; Pneumothorax; Thoracic Trauma; FDA; Battlefield Death 

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