You are here

Development of a Junctional Tourniquet

Description:

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care

 

OBJECTIVE: To rethink the form factor and engineering approach of existing junctional tourniquets, providing reliable control of junctional hemorrhage. Such a solution must be readily accessible at the point of injury and designed to be user-friendly and intuitive, enabling use by non-medical personnel for self-aid and buddy care scenarios.

 

DESCRIPTION: Exsanguination from massive blood loss accounts for more than 80% of potentially survivable battlefield deaths [1]. A junctional tourniquet solution would address the 32% of these fatalities that arise from uncontrollable extremity and junctional bleeding [2]. Junctional tourniquets apply external compression to stop blood flow in the groin and axilla, i.e., at the junction of the trunk and the appendages. Junctional indication demands precise placement and, ideally, single-point pressure. The tourniquet design must ensure user accuracy in high-stress situations. Currently, four designs meet FDA approval and have shown effectiveness in occlusion under controlled conditions [3]. This topic seeks a form factor that allows for fast and easy application by non-medical personnel with minimal training.

 

When proposing a technology, consider the following factors:

  • The device should be able to control a junctional bleed within about one minute as operated by a trained user.
  • Ideally, a well-designed junctional tourniquet can replace the use of an extremity tourniquet.
  • The total weight of the device should be under 1.5 lbs. The stored volume should be no more than 500 cubic inches to remain minimal for transport and individual warfighter use.
  • The design should be amenable to one handed use.
  • Engineer the device to efficiently manage both upper and lower junctional hemorrhage through compression of axillary and femoral arteries, respectively.
  • Ensure the device's availability at the point of injury, i.e., it must be able to be commonly carried.
  • Use of the device shall be simple with minimal steps. Anatomical knowledge should not be required for operation of the device. Device shall not require more than 2 hours of standardized training.
  • The tourniquet design should address stability over time, including factors such as physiological response to hemorrhage, type of uniform, surface conditions (blood or rain) and transport.
  • The materials should have the ability to withstand dirt/dust/sand, UV exposure, fresh and salt water, hot and cold temperatures, requiring minimal special storage conditions.
  • Engineering solutions should require minimum logistical/technical support.

 

PHASE I: Phase I feasibility will be demonstrated through evidence of: a completed proof of concept/principal or basic prototype system; definition and characterization of framework properties/technology capabilities desirable for both Department of Defense/Government and civilian/commercial use; and capability/performance comparisons with existing state-of-the-art technologies/methodologies (competing approaches).

 

Phase I-type effort: conduct a study to determine the technical feasibility (as demonstrated through clinical data, benchtop testing, etc.), end-user human factors testing and an initial design of a junctional tourniquet.

 

PHASE II: During this phase, the offeror will advance the system towards TRL 4, refining it from a proof-of-concept. The design should be optimized for efficacy and qualitative and quantitative hemorrhage control outcomes should be demonstrated to include metrics such as the time to apply to occlusion and percentage of successful occlusion attempts (i.e., how does the tourniquet fit different anthropomorphic types). Testing and evaluation of the prototype to demonstrate operational effectiveness in simulated stressful environments should be demonstrated. Stability of the product over time (to include considerations for physiological response to hemorrhage, type of uniform, surface conditions (bloody or wet) and transport) and survivability of the materials under extreme conditions (heat, cold, wet, UV and dirt/dust) should be demonstrated. Draft application instructions, procedures, technical specifications, and training materials should be provided for technical and end-user evaluation. A major criteria for acceptance by the end-user will be a favorable form factor in order for the device to be carried at all times. The offeror should plan to deliver fifteen example prototypes at the end of the Phase II effort for Government evaluation. The offeror shall articulate the regulatory strategy and provide a clear plan on how FDA clearance will be obtained.

 

PHASE III DUAL USE APPLICATIONS: The goal of this phase is to secure an FDA approved device and demonstrate effectiveness and usability for the military and civilian end-user. Funding from either a non-SBIR Government source (e.g., Navy Advanced Medical Development, U.S. Army Medical Materiel Development Activity’s Warfighter Expeditionary Medicine and Treatment Project Management Office, Marine Corps System Command, Joint Warfighter Medical Research Program), the private sector, or both should be investigated to develop the prototype into a viable product for sale in military and/or private sector markets. Civilian end-users can include police, fire and medical first responders, hospitals, air ambulance and evacuation, recreational medical services such as lifeguards and ski patrol, and emergency management agencies. Scenarios requiring junctional tourniquets can include automobile and motorcycle accidents, industrial accidents, mass shootings, terrorist incidents and natural disasters.

 

REFERENCES:

  1. Naimer, S.A. (2014) A Review of Methods to Control Bleeding from Life-Threatening Traumatic Wounds. Health, 6, 479-490. http://dx.doi.org/10.4236/health.2014.66067
  2. B. Eastridge, J. Holcomb and S. Shackelford, "Outcomes of traumatic hemorrhagic shock and the epidemiology of preventable death from injury," Transfusion, vol. 59, no. S2, pp. 1423-1428, 2019. https://doi.org/10.1111/trf.15161
  3. Humphries, R.; Naumann, D.N.; Ahmed, Z. Use of Haemostatic Devices for the Control of Junctional and Abdominal Traumatic Haemorrhage: A Systematic Review. Trauma Care 2022, 2, 23–34. https://doi.org/10.3390/traumacare2010003

 

KEYWORDS: Hemorrhage Control, Tourniquet, Combat Casualty Care, En Route Care, Mass Casualty, Prolonged Field Care, Trauma, Junctional, Extremity, Care Under Fire, Buddy Care

US Flag An Official Website of the United States Government