Smart sensor for guiding safe delivery of anesthetic and pain drugs through epidurals

智能传感器用于指导通过硬膜外麻醉剂和止痛药物的安全输送

• 批准号: 10545953
• 负责人: NICUSOR IFTIMIA
• 金额: $ 25.85万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10545953
• 关键词: 3D Print; Adhesives; Anatomy; Anesthetics; Animal Model; Animals; Birth; Blindness; Brachytherapy; Catheters; Cervical; Chemicals; Chronic neck pain; Clinical; Clinical Investigator; Collaborations; Computer software; Cystic Lesion; Development; Device or Instrument Development; Devices; Drug Delivery Systems; Dura Mater; Engineering; Epidural Anesthesia; Epidural Injections; Evaluation; Excision; Failure; Family suidae; Fluoroscopy; Goals; Government; Headache; Health; Healthcare Systems; Helping to End Addiction Long-term; Hospital Costs; Hospitals; Human; Image; Infection; Interferometry; Israel; Laboratories; Ligaments; Measures; Monitor; Movement; Nature; Needles; Operative Surgical Procedures; Optics; Pain; Pain Clinics; Pain management; Paralysed; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Phase; Positioning Attribute; Procedures; Puncture procedure; Resistance; Resolution; Secondary to; Secure; Slipped Disk; Specialist; Specimen; Spinal Stenosis; Spine surgery; Stroke; Syndrome; Syringes; Techniques; Technology; Testing; Tissues; Training; Vertebral column; Woman; Work; animal tissue; base; chronic pain; comparative; discogenic pain; epidural space; improved; in vivo; instrument; instrumentation; interstitial; ligamentum flavum; member; meter; migration; nerve damage; new technology; novel; novel strategies; physical science; pre-clinical; pressure; prevent; programs; prototype; response; sensor; sensor technology; side effect; standard of care; success; therapy development

Project Summary/Abstract Physical Sciences Inc. (PSI), in collaboration with anesthesiologists from Beth Israel Deaconess (BID) Hospital and Brigham and Women’s Hospital (BWH), who will act as consultants in Phase I and clinical investigators in Phase II, proposes to develop a novel approach for guiding safer delivery of pain and/or anesthetic drugs during epidural procedures (EPs). Epidural injections are typically used to treat pain from herniated discs, spinal stenosis, chemical discs, chronic pain secondary to post-cervical surgery syndrome, and chronic neck pain of discogenic origin. They are also regularly used to alleviate pain related to birth. However, when not properly performed, the epidural injections can have negative side effects, such as severe headache, infection, and even nerve damage. Serious side effects may also occur, including stroke, paralysis, or loss of vision. A new technology based on a novel optical sensing technique is proposed to assess tissue composition and optimize the force applied to the needle to guide its safe insertion into the epidural space, while the monitoring of the pulsatile pressure in the epidermal space is proposed for evaluating proper positioning of the drug delivery catheter. The Phase I effort will focus on development of a laboratory prototype that will be initially tested and optimized ex vivo on animal tissue specimens, and then preliminarily evaluating its efficacy in vivo in swine. Based on the Phase I findings, the technology will be further improved during Phase II and validated on humans at BWH.

项目摘要/摘要 物理科学公司(PSI)与贝丝以色列女执事(BID)的麻醉师合作 医院和布里格姆妇女医院(BWH)，他们将担任第一阶段和临床的顾问 第二阶段的研究人员建议开发一种新的方法来指导更安全的疼痛和/或 硬膜外手术(EP)中的麻醉药。硬膜外注射通常用于治疗 椎间盘突出，椎管狭窄，化学性椎间盘，颈椎手术后综合征继发的慢性疼痛， 和颈椎病引起的慢性颈痛。它们也经常被用来缓解与分娩有关的疼痛。 然而，如果操作不当，硬膜外注射可能会产生负面副作用，例如 严重的头痛，感染，甚至神经损伤。还可能出现严重的副作用，包括中风， 瘫痪，或失明。 提出了一种基于一种新的光学传感技术来评估组织成分的新技术 并优化施加在针上的力，以引导其安全插入硬膜外间隙，而 建议监测表皮间隙的脉动压，以评估正确的位置。 药物输送导管。第一阶段的工作将集中在开发实验室原型，该原型将是 在动物组织标本上进行了初步的体外测试和优化，并初步评价了其效果 在猪体内。根据第一阶段的研究结果，该技术将在第二阶段和 在BWH的人体上进行了验证。