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.

该阶段II SBIR完成了BabyGentleStick（BGS）的开发和商业化，该设备旨在 通过振动诱导的麻醉减轻足跟棒的疼痛和压力。BGS通过 将市售的足跟刺血针刺入目标区域，有效地麻木/掩蔽疼痛信号， 以及在兰辛期间。在临床评价中，I期研究显示疼痛反应显著降低。 新生儿的血液采集是常规必要的，使用足跟棒（用锋利的针头穿透毛细血管床） 这是小样本最常用的技术。高跟鞋被认为是最常见的 在新生儿重症监护室（NICU）进行的疼痛程序，导致反复疼痛反应 这对发展产生了负面影响。这种痛苦刺激了大量旨在开发 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 护理/肌肤接触、电刺激、白色噪音、母乳喂养、音乐和按摩。临床和 实验室研究表明，早产儿特别容易受到伤害， 重复刺激。最近，新生儿大脑发育可塑性的证据表明， 在此期间的痛苦经历或长期暴露于镇痛药物可能会改变神经元和 突触组织永久。需要一种解决方案，其提供无药物的疼痛减轻， 新生儿对足跟针刺和穿刺后足跟挤压的应激反应。BGS实现了这些目标， 符合NIH/NICHD的“创新理念，减轻NICU工作人员、父母和婴儿的压力”目标 和“方法，以减少疼痛的所有围产期护理新生儿，在分娩的母亲，在产后 自然分娩和剖腹产后死亡”其创新之处在于结合了振动诱导 在单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 样品质量或体积。第二阶段假设。BGS安全有效地减轻疼痛和压力 在新生儿足跟针刺过程中的反应。具体目标。目标1 -纳入设计改进 从第一阶段开始，进行可用性确认，并达到BGS的设计冻结。监管讨论， FDA.验收标准。BGS接受最常用于鞋跟贴系列的切口式柳叶刀 在美国，与HMC和NCH的临床医生进行的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、监管提交和生产。验收标准。 成功完成验证和确认（V&V）。FDA批准试验用器械豁免 （IDE）.生产的临床用品。目标3 -通过以下方式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。 验收标准。BGS显著降低了针刺期间的疼痛反应以及行为适应症 新生儿在穿刺后脚跟挤压时的痛苦。BGS监管许可。