Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates

振动集成采血系统可减少新生儿反复出现的足跟刺痛造成的压力、疼痛反应、足跟损伤和发育危害

• 批准号: 10009647
• 负责人: Ryan S Clement
• 金额: $ 113.6万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-18 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009647
• 关键词: Address; Adult; Analgesics; Anesthesia procedures; Area; Behavioral; Blood; Blood specimen; Breast Feeding; Cesarean section; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Collection; Development; Device Designs; Devices; Distress; Electric Stimulation; Ensure; Event; Exhibits; Exposure to; Freezing; Glucose; Goals; Hand; Heel; Housing; Infant; Injections; Investigation; Kangaroo-Mother Care; Knowledge; Laboratory Study; Lead; Manufactured Supplies; Masks; Massage; Medical; Medical Device; Medical center; Methods; Mothers; Motion; Music; National Institute of Child Health and Human Development; Needles; Needlestick Injuries; Neonatal; Neonatal Intensive Care Units; Neurons; Newborn Infant; Noise; Numbness; Oral; Pain; Parents; Patient-Focused Outcomes; Pediatric Hospitals; Penetration; Perinatal Care; Pharmaceutical Preparations; Phase; Postpartum Period; Procedures; Rodent; Safety; Sales; Sampling; Site; Skin; Skin Care; Small Business Innovation Research Grant; Speed; Stimulus; Stress; Sucrose; Surgical incisions; Synapses; System; Techniques; Technology; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; Validation; biological adaptation to stress; capillary bed; clinical practice; commercialization; design; developmental plasticity; experience; handheld equipment; improved; innovation; neonatal brain; neonate; non-nutritive sucking; pain reduction; pain signal; preterm newborn; prototype; research clinical testing; response; stress reduction; success; usability; verification and validation; vibration

This Phase II SBIR finalizes development and commercializes BabyGentleStick (BGS), a device designed to reduce pain and stress of heel sticks through vibration-induced anesthesia. BGS delivers vibration via a commercially available heel stick lancet to the target area, effectively numbing/masking pain signals prior to and during lancing. Phase I demonstrated compelling reductions in pain response in clinical evaluations. Blood collection in neonates is routinely necessary, with heel sticks (penetration of capillary bed with a sharp) being the most common technique for small samples. Heel sticks are considered one of the most frequent painful procedures performed in the neonatal intensive care unit (NICU), resulting in a repeated pain response that negatively impacts development. This pain 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. 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. A solution is needed that provides drug-free reduction of the pain and stress responses to heel sticks and post-lance heel squeezing in neonates. BGS achieves these aims and meets the NIH/NICHD goals of “Innovative ideas to reduce stress for the staff, parents and infants in the NICU” and “Methods to reduce pain in all of perinatal care in newborn infants, in mothers in labor, during postpartum after spontaneous delivery and cesarean section.” The innovation is the combination of vibration-induced anesthesia with a high-speed automatic lance in a single easy-to-use Handpiece, without compromising blood sample quality or volume. Phase II Hypothesis. BGS is safe and effective for reducing pain and stress responses during neonatal heel stick procedures. Specific Aims. Aim 1 – Incorporate design improvements from Phase I, conduct usability validation, and reach Design Freeze for BGS. Regulatory discussions with FDA. Acceptance Criteria. BGS accepts incision-style lancets most commonly used for heel stick collections in the U.S. A usability study with clinicians at HMC and NCH confirms design changes and usability. Aim 2 – Transition BGS toward clinical studies, Regulatory Submission, and Manufacturing. Acceptance Criteria. Successful completion of Verification and Validation (V&V). FDA approval of Investigational Device Exemption (IDE). Clinical Supplies Manufactured. Aim 3 – Demonstrate reduction in pain and stress response through clinical studies (Nationwide Children’s and Hershey Medical Center) and prepare Regulatory Submission. Acceptance Criteria. BGS significantly reduces pain response during lance as well as behavioral indications of distress during the post-lance heel squeeze in neonates. BGS Regulatory clearance.

第二阶段 SBIR 完成开发并将 BabyGentleStick (BGS) 商业化，该设备旨在 通过振动引起的麻醉来减轻脚跟的疼痛和压力。 将市售的后跟刺血针刺入目标区域，在手术前有效麻木/掩盖疼痛信号 在临床评估中，第一阶段的疼痛反应明显减少。 新生儿的血液采集通常是必要的，使用足跟棒（用锋利的刺入毛细血管床） 脚跟棒是小样本最常用的技术，被认为是最常见的技术之一。 在新生儿重症监护室 (NICU) 进行的痛苦手术，导致反复疼痛反应 这种痛苦刺激了许多旨在发展的研究。 缓解不适的策略，包括使用口服蔗糖、葡萄糖、非营养性吸吮、袋鼠式 护理/皮肤接触、电刺激、白噪音、母乳喂养、音乐和按摩。 实验室研究表明，早产儿特别容易受到伤害，并且可能表现出对 最近，新生儿大脑发育可塑性的证据表明重复刺激。 在此期间的痛苦经历或长期接触镇痛药物可能会改变神经元和 需要一种无需药物即可永久减轻突触组织的解决方案。 BGS 对脚后跟棍棒和枪后脚跟挤压的应激反应实现了这些目标。 满足 NIH/NICHD 的“减少 NICU 工作人员、父母和婴儿压力的创新理念”的目标 以及“减轻新生儿、产妇、产后所有围产期护理中疼痛的方法” 自然分娩和剖腹产后的创新是振动诱导的结合。” 在一个易于使用的手机中使用高速自动喷枪进行麻醉，而不会影响血液 第二阶段假设的样本质量或体积对于减轻疼痛和压力是安全有效的。 具体目标 1 – 纳入设计改进。 从第一阶段开始，进行可用性验证，并与 BGS 达成设计冻结监管讨论。 FDA 验收标准。BGS 接受最常用于足跟棒采血的切口式采血针。 在美国，HMC 和 NCH 的资深人士进行的一项可用性研究证实了设计变更和可用性目标 2 – 将 BGS 过渡到临床研究、监管提交和制造验收标准。 成功完成 FDA 对研究器械豁免的验证和确认 (V&V)。 (IDE) 制造临床用品 目标 3 – 证明通过减少疼痛和压力反应。 临床研究（全国儿童和好时医疗中心）并准备监管提交。 BGS 显着降低了刺针期间的疼痛反应以及行为适应症。 BGS 监管许可。