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Additive Manufacturing of Patient-Specific Masks and Nasal Prongs to Improve Pediatric Ventilation Outcomes and Reduce Pressure Sores

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44HD105552-01
Agency Tracking Number: R44HD105552
Amount: $309,518.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA20-262
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-05-01
Award End Date (Contract End Date): 2022-04-30
Small Business Information
Bellefonte, PA 16823-8445
United States
DUNS: 791379030
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (814) 355-0003
Business Contact
Phone: (814) 355-0003
Research Institution

In this Fast-track SBIR Actuated Medical, Inc., is partnering with the Children’s Hospital of Philadelphia
(CHOP) and Akron Children’s Hospital (ACH) to develop processes to manufacture better fitting masks and
nasal prongs for Non-invasive Ventilation (NIV) delivery to young pediatric patients (1 month to 9 years of age).
NIV provides breathing support without the use of an endotracheal or tracheostomy tube. NIV is delivered by
interfaces (a mask or nasal prongs). Generally, masks only cover the nose to mitigate potential aspiration
concerns should a patient vomit. Nasal prongs are intended to achieve a 100% occlusive fit within a patient’s
nare. For both masks and prongs, the goal is to deliver airway support maintaining positive-end expiratory
pressure (PEEP). Poorly fitting masks can lead to non-compliance, patient–ventilator dys‐synchronies, skin
damage, pain, craniofacial skeletal issues, and can also result in delivery of sub-optimal pressures or tidal
volume, which can adversely affect ventilation outcomes, particularly in the home care setting. Additionally,
poorly fitting NIV interfaces can require them to be strapped to patients tightly to offset the inferior fit, which can
lead to pressure ulcers, skin damage, or septum injury (in the case of nasal prongs). While many NIV delivery
methods exist for neonatal patients (3 available mask and 11 nasal prong sizes), there are no sizes designed
specific to young pediatric patients (1 month to 9 years old) that are equipped with appropriate headgear. The
validation process to stand up a manufacturing approach is costly and time consuming for a relatively small
market, limiting the interest of major manufacturers to fill these gaps. Three main limitations arise when
addressing the needs of younger patients: 1) the size gap between neonatal and adult interfaces leave poor
solutions for young pediatric patients, 2) variation in patient facial structure results in NIV interfaces being
pushed too firmly against the face in an attempt to eliminate or reduce air leakage, and 3) craniofacial
anomalies (CFAs) (e.g. cleft lip) further limit the ability to achieve a good seal. An approach is needed that will
produce NIV interfaces that address these gaps, while being FDA-compliant and still economically feasible.
Phase I. Hypothesis. Pediatric-specific sized NIV mask and prongs can be manufactured using 3D printing
methods to improve ventilation outcomes in benchtop models. Aim 1. Verify improved performance of
pediatric-sized NIV devices fabricated through facial scanning and injection molding process. Aim 2 –
Formulation development and testing for direct 3D printing approach.
Phase II. Hypothesis. Manufacturing NIV devices with 3D printing yields better fitting interfaces that improve
NIV outcomes in young pediatrics. Aim 3 – Validate manufacturing approach for pediatric NIV interfaces. Aim 4
– Finalize direct 3D print approach and evaluate performance with CFAs. Aim 5 – Multi-site human clinical
evaluations (CHOP, n=29; ACH, n=24)Project Narrative:
Relevance – Non-invasive ventilation (NIV) is used to provide breathing support without the challenges
encountered with an endotracheal tube. NIV is delivered either by masks or prongs. A tight seal is critical, but
without having to pull the mask so tight that it generates pressure sores. While many NIV options exist for
neonatal patients, options are poor for pediatric patients age 1 month to 9 years. This SBIR project develops
and tests Patient Specific Pediatric Nasal Prongs and Masks produced using conventional molding and 3D
printing. The goal is to provide a) a better range of sizes for pediatrics and b) patient specific ventilation for
unusual facial structures (e.g. cleft lip, midface hypoplasia).

* Information listed above is at the time of submission. *

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