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)
Public Health Relevance Statement: 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).
Project Terms: Adult; 21+ years old; Adult Human; adulthood; Affect; Age; ages; Air; Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Award; Cell Survival; Cell Viability; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Cleft Lip; Harelip; hare lip; decubitus ulcer; Bed Sores; Bedsore; Pressure Sore; Pressure Ulcer; pressure injury; Extravasation; Leakage; Spillage; Face; faces; facial; Gases; Goals; Cyclic GMP; Guanosine Cyclic Monophosphate; cGMP; Pediatric Hospitals; Children's Hospital; Human; Modern Man; Intubation; Lead; Pb element; heavy metal Pb; heavy metal lead; Manikins; Mannequins; Masks; Medical Device; Methods; Nose; Nasal; Nasal Passages Nose; Respiratory System, Nose, Nasal Passages; Pain; Painful; Patients; Pediatrics; Philadelphia; Positive-Pressure Respiration; Positive End-Expiratory Pressure; positive pressure breathing; pressure; Research; Plant Resins; resin; Sales; seal; Technology; Testing; Tidal Volume; respiratory airway volume; Time; Vomiting; Emesis; Ventilator; Custom; Injury; injuries; Tube; Tracheostomy Tube; trach tube; improved; Continuous Positive Airway Pressure; CPAP; CPAP Ventilation; patient home care; Home Care; patient homecare; Site; Phase; Variant; Variation; Medical; Ensure; Childhood; pediatric; Collaborations; Filamentous Fungi; Molds; Knowledge; craniofacial anomalies; craniofacial defects; craniofacial malformation; Craniofacial Abnormalities; Dimensions; Scanning; System; non-compliant; noncompliance; noncompliant; non-compliance; skeletal; Inferior; interest; biocompatibility; biomaterial compatibility; craniofacies; craniofacial; Lytotoxicity; cytotoxicity; Performance; endotracheal; Structure; Devices; cl/p; cleft of the lip and/or palate; Cleft lip with or without cleft palate; Modeling; Manufacturer; Manufacturer Name; Address; Data; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; Process; Development; developmental; Pathway interactions; pathway; cost; design; designing; Outcome; manufacturing process; Neonatal; Consumption; innovation; innovate; innovative; 2 year old; 2 years of age; age 2 years; aged 2 years; aged two years; two year old; two years of age; 9 year old; 9 years of age; age 9 years; nine year old; nine years of age; file format; commercialization; high risk; standard of care; standard care; standard treatment; flexibility; flexible; 3D Print; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; pediatric patients; child patients; Formulation; neonatal patient; Injections; ventilation; skin damage; cutaneous damage; dermal damage
