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Development and Testing of Dual-lumen Femoral Cannula with Echogenic Material for Faster, Safer, and More Reliable Delivery of Extracorporeal Life Support during Prolonged Field Care

Description:

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): COMBAT CASUALTY CARE OBJECTIVE: Design, build, and demonstrate a femoral dual-lumen cannula that will allow for the initiation of lifesaving extracorporeal life support (ECLS) treatment in a prolonged-field-care environment. The end goal is to save the lives of warfighters with severe lung failure. This will be accomplished by (1) limiting the risks associated with two separate cannula placements; (2) enabling confirmation of cannula placement by means of handheld ultrasound in the field; and (3) making cannulation easy to perform by non-subspecialist providers. DESCRIPTION: Over the past two decades, industry advancements in material science and engineering for ECLS have led to exponential growth in the use of this technology worldwide, for the treatment of patients with lung failure caused by, e.g., trauma, burns, or COVID-19. ECLS is the most advanced form of life support in existence for combat casualties and other patients experiencing acute cardiac and/or pulmonary failure [1]. ECLS provides support for these patients using an artificial membrane lung and blood pump. It provides gas exchange and systemic perfusion for patients when their own heart and/or lungs are unable to function adequately, and it has been shown to improve survival rates and outcomes in patients with severe acute respiratory distress syndrome (ARDS). A retrospective series by Bein et al of U.S. casualties placed on ECLS both in theater and at Landstuhl Regional Medical Center from 2005 to 2011 showed a 1-year survival rate of 90% [2]. However, there are major limitations for the use of ECLS in both far-forward and en route environments. These include the difficulty of cannulation, the need for advanced imaging to avoid damage to the heart and great vessels during cannulation, and difficulty in confirming correct cannula placement both during cannulation and en route. ECLS requires placement of either two separate cannulas (e.g., internal jugular vein in the neck, and femoral vein in the groin), or a single dual-lumen cannula (internal jugular vein in the neck). Cannula placement in the internal jugular (IJ) vein is currently performed in advanced clinical settings by skilled users. This type of placement can be technically challenging, requiring a high degree of precision in addition to large and expensive adjunctive imaging such as fluoroscopy or transesophageal echocardiogram to ensure proper placement. This ease-of-cannulation problem is the single greatest obstacle to wider use of ECLS on the battlefield or in the civilian community. This topic calls for the development of a dual-lumen cannula for femoral vein placement, which would overcome the problems of complex imaging requirements and limited experience. This would enable ECLS initiation on the battlefield. The goal is a faster, safer, and more reliable delivery of ECLS to the combat casualty on the battlefield. A dual-lumen cannula for femoral vein placement could be safely used in a Role 2 or 3 facility. The femoral location is easier and safer in the hands of a less-experienced operator than placement in the neck or chest. A femoral catheter will remain in place until the patient arrives at a Role 4 facility; there, the patient would be evaluated for a long-term cannulation strategy, such as two-site cannulation or upper body dual lumen cannulation—if necessary. It would allow for evacuation of patients off the battlefield who have high ventilator settings, that would otherwise preclude them from movement. Additionally, the design would decrease the overall risks of placing two cannulas compared to one cannula. Finally, the design would allow for the cannula to be converted into a drainage cannula if conversion to a definitive two-site cannulation strategy is needed for higher or more efficient blood flow at the higher level of care. Maintaining correct cannula position is paramount. Low cannula positions may result in high negative access pressures and altered flow dynamics, and high cannula positions may result in trauma to blood vessels and the heart. Furthermore, upper body dual-lumen cannulation is simply not feasible for enhanced combat casualty care, given the technical challenges of placement and the risk of vascular perforation. In order to mitigate potential wire misplacement, this technology must be designed with echogenic materials to enable determination of cannula location with hand-held ultrasounds, in lieu of x-ray or fluoroscopy. This type of material will ensure that the cannula is placed correctly. Between a dual-lumen cannula for femoral placement and the echogenic material, this catheter would be ideal for civilian uses in rural hospitals; providers could place the catheter in the less-specialized hospital until transport to a tertiary referral hospital. PHASE I: Given its short duration, Phase I should focus on system design and development of proof-of-concept prototypes for a dual lumen cannula for femoral vein placement with echogenic material. At the end of this phase, fabricated prototypes should demonstrate feasibility using relevant testing platforms for the proposed technology, including reasonable detection of the cannula by ultrasound. Evaluation of the product’s durability should include data for the first 6, 24, 48, and 72 hours at a minimum. No animal or human subjects should be utilized in Phase I. Testing and evaluation of the prototype will demonstrate operational effectiveness in simulated environments (i.e., integrity of bonded connectors and joints, kinking of cannula, incidence of stress fractures, etc.). Simulations should utilize a high-fidelity cannulation simulator. PHASE II: During this phase, the integrated device should be further refined from proof-of- concept into a viable prototype. Further optimization of the technology as a single-use, echogenic dual-lumen catheter that provides both venous drainage and reinfusion of blood via the femoral vein should demonstrated during this phase. Qualitative and quantitative outcomes of product include cannula size availability (26 and 28 Fr.), the inclusion of an introducer to facilitate wire-guided placement into the vasculature by normal access techniques, wire reinforcement of the catheter for flexibility and kink-resistance, and the inclusion of depth marks and tantalum markers for ultrasound confirmation. A vessel dilator for percutaneous catheterization may be included to assist in vessel cannulation. The cannula and guidewire with echogenic material should undergo bench testing under rigorous conditions. Verification and validation testing should be used to establish the performance characteristics of the dilators, including biocompatibility, packaging integrity, transportation integrity, sterilization validation, and functional testing. Product optimization should achieve desirable duration, security, and the ability to be deployed. Testing and evaluation of the prototype will demonstrate operational effectiveness in simulated environments (i.e., cannulation success rate, time from initiation of cannulation to confirmation of correct placement, etc.). Simulations should utilize a high-fidelity cannulation simulator. Simulated use of the device should be tested by a diverse clinical team to include providers with varying degrees of cannulation expertise. The offeror will articulate the regulatory strategy and provide a clear plan on how FDA clearance will be obtained. PHASE III DUAL USE APPLICATIONS: The ultimate goal of this phase is to achieve FDA submission with the proper regulatory clearance or authorization for human or Department of Defense (DOD) use exemption. Phase III funding strategies could include CDMRP funding announcements and/or other DOD opportunities. Accompanying application instructions, simplified procedures, and training materials will be drafted in a multimedia format for both civilian and military use and integration of the product into market. Once developed and demonstrated, the technology must be adaptable for both civilian and military settings to save lives. RESEARCH INVOLVING ANIMAL OR HUMAN SUBJECTS The SBIR/STTR Programs discourage offerors from proposing to conduct Human or Animal Subject Research during Phase 1 due to the significant lead time required to prepare the documentation and obtain approval, which will delay the Phase 1 award. All research involving human subjects (to include use of human biological specimens and human data) and animals, shall comply with the applicable federal and state laws and agency policy/guidelines for human subject and animal protection. Research involving the use of human subjects may not begin until the U.S. Army Medical Research and Materiel Command's Office of Research Protections, Human Research Protections Office (HRPO) approves the protocol. Written approval to begin research or subcontract for the use of human subjects under the applicable protocol proposed for an award will be issued from the U.S. Army Medical Research and Materiel Command, HRPO, under separate letter to the Contractor. Non-compliance with any provision may result in withholding of funds and or the termination of the award. REFERENCES: 1. Gray, B.W., et al., Extracorporeal life support: experience with 2,000 patients. ASAIO J, 2015. 61(1): p. 2-7; 2. Bein, T., et al., Transportable extracorporeal lung support for rescue of severe respiratory failure in combat casualties. J Trauma Acute Care Surg, 2012. 73(6): p. 1450-6; KEYWORDS: extracorporeal life support (ECLS), cannula, echogenic
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