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Combat Diagnostic Chest Dressing
Navy SBIR 2009.2 - Topic N092-148 ONR - Mrs. Tracy Frost - [email protected] Opens: May 18, 2009 - Closes: June 17, 2009 N092-148 TITLE: Combat Diagnostic Chest Dressing TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: Force Health Protection FNC The technology within this topic is restricted under the International Traffic in Arms Regulation (ITAR), which controls the export and import of defense-related material and services. Offerors must disclose any proposed use of foreign nationals, their country of origin, and what tasks each would accomplish in the statement of work in accordance with section 3.5.b.(7) of the solicitation. OBJECTIVE: The objective is to design and build an inexpensive chest dressing that alerts the caregiver to a developing pneumothorax. DESCRIPTION: There are currently several chest dressings currently on the market. However, none of the current chest dressings have any diagnostic capability. The need is for a dressing that can alert the care provider to the development of a pneumothorax so the apporpriate life-saving intervention can be made. Patient complaint (if conscious) and uneven chest sounds are diagnostic provided the medic/corpsman has time to constantly monitor the patient. However, this may be difficult (a) under fire, (b) when there are multiple casualties who require monitoring, or (c), in a high noise environment such as during CASEVAC. The concept is feasible since the increased pressure will develop on the side of the chest that has been penetrated and to which the chest seal has been applied. Performance parameters include: Sized to fit most combat chest wounds; Adhesion properties to survive the operational environment; Indicator for developing pneumothorax. PHASE I: Tasks are: (1) Design and develop a chest dressing that has diagnostic capability; (2) Develop an initial plan to achieve FDA regulatory approval. PHASE II: Tasks are: (1) Enhance the design of the Phase I dressing by addition of an electronic sensor to detect increasing thoracic pressures which can be transmitted to a monitor; (2) Demonstrate the prototype system in an animal model; (3) Conduct testing to prove feasibility over extended operating conditions (extreme heat, cold, maritime environment). PHASE III: Tasks are: (1) Obtain FDA approval. It is doubtful that a suitable civilian population will be available to demonstrate safety and efficacy so it is likely that the FDA will allow evidence obtained under the "Two-Animal Model" rule to suffice. PRIVATE SECTOR COMMERCIAL POTENTIAL/DUAL-USE APPLICATIONS: The technology could be used for the treatment of thoracic wounds. Civilian applications would most likely be limited to mass casualty situations which would have limited care providers and delayed transport to a hospital. REFERENCES: 2. An evaluation of tactical combat casualty care interventions in a combat environment. Tien HC, Jung V, Rizoli SB, Acharya SV, MacDonald JC. J Am Coll Surg. 2008 Aug;207(2):174-8. Epub 2008 May 12. 3. Causes of death in U.S. Special Operations Forces in the global war on terrorism: 2001-2004. Holcomb JB, McMullin NR, Pearse L, Caruso J, Wade CE, Oetjen-Gerdes L, Champion HR, Lawnick M, Farr W, Rodriguez S, Butler FK. Ann Surg. 2007 Jun;245(6):986-91. KEYWORDS: chest, dressing, pneumothorax, indicator, sensor
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