Oscillated Needle System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates

Period of Performance: 05/18/2016 - 04/29/2017

$274K

Phase 1 STTR

Recipient Firm

Actuated Medical, Inc.
Bellefonte, PA 16823
Principal Investigator

Abstract

? DESCRIPTION (provided by applicant): This Phase I STTR - in response to RFA-HD-16-028 Non- or Minimally-Invasive Methods to Measure Biochemical Substances during Neonatal and Perinatal Patient Care and Research - develops and tests Baby Gentle Stick (BGS), a handheld device to decrease the distress of repeat blood sampling in neonates. BGS combines delivery of vibration-induced anesthesia with oscillated lancet insertion to reduce heel stick pain Blood collection in neonates is routinely necessary, with heel sticks (penetration of capillary bedwith a sharp) being the most common technique for small samples (< 200 µL). Heel sticks are one of the most frequent painful procedures performed in the NICU, resulting in a repeated pain response, believed to negatively impact development. The pain associated with heel sticks has stimulated a multitude of studies aimed at developing strategies to alleviate discomfort, including the use of oral sucrose, glucose, non-nutritive sucking, kangaroo care/skin-to skin contact, electrical stimulation, white noise, breastfeeding, music, and massage. Moreover, clinical and laboratory studies suggest that preterm neonates are especially vulnerable and can exhibit sensitization to repeat stimuli. Recently, evidence for developmental plasticity in the neonatal brain suggests that repetitive painful experiences during this period or prolonged exposure to analgesic drugs may alter neuronal and synaptic organization permanently. The significance of this STTR is that a device is needed that provides drug-free reduction of the pain response, while simultaneously improving success rates and sample volumes, eliminating multiple attempts and reducing tissue damage. The innovation of this STTR is the combination of vibration-induced anesthesia with high-speed automatic lance in a single handheld device that lances with less pain and trauma, without compromising blood sample quality or volume. Baby Gentle Stick achieves these aims and meets the NIH/NICHD goal of Innovative ideas to reduce stress for the staff, parents and infants in the NICU (2015 SBIR/STTR Program Descriptions). Phase I Hypothesis. The pain response from the lancing event will be lessened with BGS, leading to less stressful heel stick blood collection in neonates than current practice. Specific Aims. Aim 1 - Development of BGS with mechanical performance verifications (AMI & Penn State University College of Medicine (PSU), Month 1-6). Acceptance Criteria. BGS hand piece meets all design requirements, including being battery-operated, be compatible with a commercially-available non-blade lancet, achieve vibration and reduction of force performance, and incision consistency. Aim 2 Demonstrate BGS reduces pain of standard heel sticks (AMI & PSU, Month 4 and 8-12). Acceptance Criteria: a) Pilot Human Study with 20 Healthy Adult Volunteers shows no adverse events, reduced pain, and receives positive clinician review, b) neonatal study (n=20) demonstrates reduced pain response (facial pain scores and skin conductance response data) while yielding functionally equivalent blood samples.