TECHNOLOGY AREA(S): Bio Medical
OBJECTIVE: On the battlefield, combat clinicians provide emergency medical care under the most challenging conditions. Remote locations, poor lighting, fire and explosions, poor road conditions, and the presence of mass casualties can lead to excessive delays in obtaining vascular access. Ultrasound guidance is the recommended technique for central venous cannulation (CVC); however, reports do exist of complications during insertion of the needle. To overcome these obstacles, there is a need to develop a vascular cannulation device that is handheld, battery-powered, and uses scanning or Doppler technology to automate all steps to gain access to central veins and arteries. This device would allow emergency medical providers without vascular training to rapidly and accurately obtain arterial or central venous access under emergency conditions without the use of external ultrasound or other imaging equipment.
DESCRIPTION: The use of invasive monitoring and hemodynamic resuscitation technology is increasing rapidly. Therefore, the ability to gain rapid and accurate vascular access is an essential skill for critical care and emergency physicians. Vascular access procedures usually involve the insertion of a flexible and sterile thin plastic tube, or catheter, into a blood vessel to provide an effective method of delivering fluids and medications, or the placement of catheter-based monitoring devices such as arterial lines, and most recently for the placement of interventional devices to control hemorrhage in trauma patients. CVCs can be inserted through the jugular, subclavian, or femoral veins or via the upper arm peripheral veins (Peripherally Inserted Central Catheters (PICC line)). Arterial access devices are often placed via the common femoral artery, the brachial artery, and the radial artery. The type of catheter and site chosen are often determined by individual clinical need and patient characteristics. Most central venous and arterial catheters are inserted using a technique of passing a guide wire through a needle (modified Seldinger technique). Vascular access requires appropriate training and education and there are several challenges and limitations with this strategy, which can impact outcomes. The first problem is the lack of experienced providers (vascular or trauma surgeon, critical care physician, or interventional radiologist, etc.) in the field to accurately perform vascular cannulation. In an emergency setting, the femoral pulse may be absent due to hypotension (as in the case of severe hemorrhage) which further complicates accurate localization for cannulation. The second problem is the unavailability of portable instruments in the field setting such as fluoroscopy, ultrasound, and x-ray machines. Third, the current procedure required for successful femoral artery sheath placement or central venous catheter placement (i.e., Seldinger Technique) requires numerous steps, instruments, and device exchanges. Lastly, in a battlefield setting, the chaotic nature of the military environment (e.g. noise, vibration, low levels of light, lack of sterility, enemy fire) makes these procedures more difficult to perform. To address these problems, there is a need to develop a vascular access device. The device should have the following characteristics: (1) able to rapidly gain access to central veins and arteries, (2) reliable for vascular cannulation, (3) self-contained, handheld, and ruggedized to withstand field use and transport, and (4) integrated scanner, Doppler, ultrasound, or other technology as a sensing mechanism. If successful, the proposed device will be used in deployed and non-deployed environments, in pre-hospital, en route, and hospital settings, in training programs, and other settings relevant to both military and civilian use.
PHASE I: The offeror should design, develop, and deliver an innovative concept for a sensing mechanism to identify vascular access location using an integrated scanner, Doppler, ultrasound, or other technology in a self-contained, handheld device. The effort should clearly analyze the scientific, technical, and commercial merit, as well as feasibility and testing in simulated environment. The offeror should include research into feasibility of developing the capability and describing the overall concept. There is No Human Use during Phase I; therefore, the use of modeling and simulation (M&S) is strongly encouraged. However, Animal Use Protocol planning and documentation should be initiated, as required. The offeror is expected to develop and demonstrate as much of the prototype design functionality as possible using M&S components. Finally, a draft commercialization plan should be developed.
PHASE II: Based on the Phase I design and development feasibility report, the offeror shall produce a prototype demonstrating potential medical utility in accordance with the success criteria developed in Phase I. The offeror will refine the vascular access device design and incorporate and refine the integrated sensing and insertion device, including software, hardware, and user interface elements. The offeror should prepare a particular study plan and should propose a protocol, with a rational for the chosen approach. The offeror should complete and test the device using simulators, cadavers, and/or animal models as appropriate, according to the regulatory plan. Evaluations of the system will encompass: data quality, real-time operation, performance measures, robustness, and consistency. The offeror will then deliver the prototype for DoD evaluation. The offeror shall deliver a report describing the design and operation of the prototype. The intent of this phase is for the developer to deliver a well-defined prototype (i.e. a technology or product) meeting the requirements of the original solicitation topic and which can be made commercially viable. The offeror shall define and document the regulatory strategy and provide a clear plan on how U.S. Food and Drug Administration (FDA) clearance will be obtained.
PHASE III: The offeror should provide validation and verification (V&V) of the device according to medical device regulations as described in FDA Code of Federal Regulations Title 21, 820.3. Follow-on activities shall include a demonstration of the application of this device to the United States Army Medical Materiel Agency (USAMMA) or other Department of Defense Advanced Development agencies, for use in deployed and non-deployed environments, in pre-hospital, en route, and hospital settings, in training programs, and other settings relevant to both military and civilian use. The offeror shall focus on transitioning the device technology from research to operational capability and shall demonstrate that this system can be used in both military and civilian settings by a broad range of medical care providers (paramedics, registered nurses, emergency medical technicians, physicians) in prehospital and austere medical environments. The offeror shall describe the specific approaches planned for regulatory submission and provide a clear plan on how FDA clearance will be obtained and the device will be commercialized.
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2: T. R. Cousins and J. M. O’Donnell, "Arterial cannulation: A critical review," AANA J.72 (4); 267–271, 2004.
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KEYWORDS: Cannulation, Femoral Artery, Vein, REBOA