Advanced Materials and Manufacturing, AFC, Phase I

Dynamic Synthetic Tissues for Medical Simulation and Training

Release Date: 06/11/2024
Solicitation: 24.4
Open Date: 06/26/2024
Topic Number: A244-052
Application Due Date: 07/30/2024
Duration: 6 months
Close Date: 07/30/2024
Amount Up To: $250,000

Objective

Develop a material-based solution which can demonstrate prolonged casualty care (PCC), nursing care, and trauma scenarios while dynamically changing the patient state based on the care being provided.

Description

Human patient simulators leverage unreliable mechanical air bladders, anatomically inaccurate synthetic tissues (Hannay et. all, 2022; Lee et. all, 2021; Norfleet et. all, 2015), and often do not accurately show a patient progression or regression during treatment.

To increase training immersion, realism, and soldier buy-in, synthetic tissue materials must increase in fidelity and be capable of emulating real medical complications. These signs and symptoms should change in appearance over time while providing learners with the correct sensory cues to indicate a need for treatment. This project targets five material response areas of interest based on common medical symptoms.

The synthetic tissue materials should demonstrate treatment proficiency feedback, i.e. the trainee performed the intervention correctly and the tissue shows improvement, or the trainee performed incorrectly, and the patient state worsens. Having synthetic tissue materials that demonstrate the cues required for intervention, look and behave realistically, respond appropriately to treatment, and dynamically change over time will improve training immersion and soldier buy-in while also enabling new PCC training scenarios.

The five targeted material response areas are:

  1. Color change and texture change
    1. Ability of the material to change color to include symptoms or injuries including bruising, infection, and blisters
    2. Inoculation – negative, positive, or no reaction
  2. Swelling/edema
    1. Controlled edema effect that does not require mechanical actuators or air bladders that detract from trainee immersion
    2. The swelling of the tissue should be identifiable by the trainee and demonstrate the need for a medical intervention.
    3. Application examples include demonstrating internal pressure from compartment syndrome that requires a pressure release through a fasciotomy.
  3. Liquid secretion
    1. Ability to secrete appropriate liquids important to, or that provide realism, for the medical procedure being performed
    2. Examples: blood, sweat, etc.
  4. The ability to produce smell based on the current state of the wound, simulation, or procedure being trained
    1. Material should be capable of demonstrating olfactory responses representative of the wound and training scenario requirements
    2. Example: burnt flesh smell for a burn scenario that requires an escharotomy
  5. Temperature control and temperature changes respective to medical conditions
    1. Emulate various levels of medical complications through the use of temperature control
    2. Examples: Fever, overheating, frostbite

Phase I

Begin feasibility of topic of the synthetic materials capable of dynamic change over time. At the culmination of Phase I, the proposer will demonstrate the functional prototype with the following requirements:

  • Integration of as many of the five capabilities mentioned in the objectives section as possible (smell, temperature, swelling, liquid secretion, and color change) is advisable.
  • The minimum requirement for phase 1 is incorporation of at least two of the objective capabilities listed above.
  • Minimum 1 inch by 1 inch size requirement with a plan for appropriate size scale-up in Phase II.
  • Outline of projected wound simulations that these materials can replicate in the following phases.

Phase II

Briefly describe expectations and minimum required deliverable, culminating in a well-defined prototype (a technology, product, or service) meeting the requirements of the topic and can be made commercially viable. (2 Yrs, $1.1M effort)

Phase II will build upon the initial findings and prototype from Phase I. This iteration will provide at least one additional capability from the previous material. This phase will also consist of a validation study on the effectiveness of the prototype as a training tool. A comparative analysis of the prototype against the current method of teaching is required.

  • Minimum integration of three capabilities in one moulage material (smell, temperature, swelling, liquid secretion, and color change).
  • The Phase 2 prototype should include tissues surrounding the wounded area.
  • Ideally, capable of demonstrating all five of the objectives over multiple moulage prototypes and overlapping integration as determined optimal for training.
  • Deliverables:
  • Dynamic materials capable of at least 3 of the identified requirements that are integrated into a wound or set of wounds that are representative of PCC, nursing care, or surgical care.
  • Complete set of wound materials and surrounding tissues that can simulate anatomical wound healing over time.
  • Capable of being sped up to “faster than real time” to allow trainees to experience the wound progression or degradation over PCC and nursing care timelines.
  • Training evaluation study or usability study of the prototype system.

Phase III

The target transition audience for the end-state will include the combat medic schoolhouses and advanced individual training locations (Camp Bullis), civilian and military nursing providers, and even some lower level surgical training providers.

The expected training experience will likely be that of a battalion aid station, Role 2, or even Role 3 depending on the performers wound selection. As part of the transition and commercialization process, Phase III should include building out relevant additional wounds and surrounding tissues based on the feedback and results found in Phase II.

Submission Information

For more information, and to submit your full proposal package, visit the DSIP Portal.

SBIR|STTR Help Desk: usarmy.sbirsttr@army.mil

A244 PHase I

References:

  • Norfleet, J., Mazzeo, M., Palata, K., Tenorio, L. M., Barocas, V., & Sweet, R. (2016). Thoracostomy Simulations: A comparison of the mechanical properties of human pleura vs synthetic training pleura. MODSIM World, 19;
  • Hannay, V., Rahul, F. N. U., Josyula, K., Kruger, U., Gallagher, S., Lee, S., … & De, S. (2022). Synthetic tissues lack the fidelity for the use in burn care simulators. Scientific Reports, 12(1), 21398.;
  • Lee, S., Rahul, Hannay, V., Gallagher, S., Lee, H., Imtiaz, A., … & De, S. (2021). Evaluate the fidelity of synthetic tissues used in escharotomy simulators. In Mechanics of Biological Systems and Materials & Micro-and Nanomechanics & Research Applications: Proceedings of the 2020 Annual Conference on Experimental and Applied Mechanics (pp. 77-80). Springer International Publishing.;
  • Norfleet, J., Fenoglietto, F. L., & Mazzeo, M. (2015). Simulated Human Tissue Performance. In MODSIM World Meeting 2015.

Objective

Develop a material-based solution which can demonstrate prolonged casualty care (PCC), nursing care, and trauma scenarios while dynamically changing the patient state based on the care being provided.

Description

Human patient simulators leverage unreliable mechanical air bladders, anatomically inaccurate synthetic tissues (Hannay et. all, 2022; Lee et. all, 2021; Norfleet et. all, 2015), and often do not accurately show a patient progression or regression during treatment.

To increase training immersion, realism, and soldier buy-in, synthetic tissue materials must increase in fidelity and be capable of emulating real medical complications. These signs and symptoms should change in appearance over time while providing learners with the correct sensory cues to indicate a need for treatment. This project targets five material response areas of interest based on common medical symptoms.

The synthetic tissue materials should demonstrate treatment proficiency feedback, i.e. the trainee performed the intervention correctly and the tissue shows improvement, or the trainee performed incorrectly, and the patient state worsens. Having synthetic tissue materials that demonstrate the cues required for intervention, look and behave realistically, respond appropriately to treatment, and dynamically change over time will improve training immersion and soldier buy-in while also enabling new PCC training scenarios.

The five targeted material response areas are:

  1. Color change and texture change
    1. Ability of the material to change color to include symptoms or injuries including bruising, infection, and blisters
    2. Inoculation – negative, positive, or no reaction
  2. Swelling/edema
    1. Controlled edema effect that does not require mechanical actuators or air bladders that detract from trainee immersion
    2. The swelling of the tissue should be identifiable by the trainee and demonstrate the need for a medical intervention.
    3. Application examples include demonstrating internal pressure from compartment syndrome that requires a pressure release through a fasciotomy.
  3. Liquid secretion
    1. Ability to secrete appropriate liquids important to, or that provide realism, for the medical procedure being performed
    2. Examples: blood, sweat, etc.
  4. The ability to produce smell based on the current state of the wound, simulation, or procedure being trained
    1. Material should be capable of demonstrating olfactory responses representative of the wound and training scenario requirements
    2. Example: burnt flesh smell for a burn scenario that requires an escharotomy
  5. Temperature control and temperature changes respective to medical conditions
    1. Emulate various levels of medical complications through the use of temperature control
    2. Examples: Fever, overheating, frostbite

Phase I

Begin feasibility of topic of the synthetic materials capable of dynamic change over time. At the culmination of Phase I, the proposer will demonstrate the functional prototype with the following requirements:

  • Integration of as many of the five capabilities mentioned in the objectives section as possible (smell, temperature, swelling, liquid secretion, and color change) is advisable.
  • The minimum requirement for phase 1 is incorporation of at least two of the objective capabilities listed above.
  • Minimum 1 inch by 1 inch size requirement with a plan for appropriate size scale-up in Phase II.
  • Outline of projected wound simulations that these materials can replicate in the following phases.

Phase II

Briefly describe expectations and minimum required deliverable, culminating in a well-defined prototype (a technology, product, or service) meeting the requirements of the topic and can be made commercially viable. (2 Yrs, $1.1M effort)

Phase II will build upon the initial findings and prototype from Phase I. This iteration will provide at least one additional capability from the previous material. This phase will also consist of a validation study on the effectiveness of the prototype as a training tool. A comparative analysis of the prototype against the current method of teaching is required.

  • Minimum integration of three capabilities in one moulage material (smell, temperature, swelling, liquid secretion, and color change).
  • The Phase 2 prototype should include tissues surrounding the wounded area.
  • Ideally, capable of demonstrating all five of the objectives over multiple moulage prototypes and overlapping integration as determined optimal for training.
  • Deliverables:
  • Dynamic materials capable of at least 3 of the identified requirements that are integrated into a wound or set of wounds that are representative of PCC, nursing care, or surgical care.
  • Complete set of wound materials and surrounding tissues that can simulate anatomical wound healing over time.
  • Capable of being sped up to “faster than real time” to allow trainees to experience the wound progression or degradation over PCC and nursing care timelines.
  • Training evaluation study or usability study of the prototype system.

Phase III

The target transition audience for the end-state will include the combat medic schoolhouses and advanced individual training locations (Camp Bullis), civilian and military nursing providers, and even some lower level surgical training providers.

The expected training experience will likely be that of a battalion aid station, Role 2, or even Role 3 depending on the performers wound selection. As part of the transition and commercialization process, Phase III should include building out relevant additional wounds and surrounding tissues based on the feedback and results found in Phase II.

Submission Information

For more information, and to submit your full proposal package, visit the DSIP Portal.

SBIR|STTR Help Desk: usarmy.sbirsttr@army.mil

References:

  • Norfleet, J., Mazzeo, M., Palata, K., Tenorio, L. M., Barocas, V., & Sweet, R. (2016). Thoracostomy Simulations: A comparison of the mechanical properties of human pleura vs synthetic training pleura. MODSIM World, 19;
  • Hannay, V., Rahul, F. N. U., Josyula, K., Kruger, U., Gallagher, S., Lee, S., … & De, S. (2022). Synthetic tissues lack the fidelity for the use in burn care simulators. Scientific Reports, 12(1), 21398.;
  • Lee, S., Rahul, Hannay, V., Gallagher, S., Lee, H., Imtiaz, A., … & De, S. (2021). Evaluate the fidelity of synthetic tissues used in escharotomy simulators. In Mechanics of Biological Systems and Materials & Micro-and Nanomechanics & Research Applications: Proceedings of the 2020 Annual Conference on Experimental and Applied Mechanics (pp. 77-80). Springer International Publishing.;
  • Norfleet, J., Fenoglietto, F. L., & Mazzeo, M. (2015). Simulated Human Tissue Performance. In MODSIM World Meeting 2015.

A244 PHase I

Dynamic Synthetic Tissues for Medical Simulation and Training

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