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.

项目总结/摘要 物理科学公司(PSI)，与Beth Israel Deaconess（BID）的麻醉师合作 医院和布里格姆妇女医院（BWH），谁将担任顾问，在第一阶段和临床 研究人员在第二阶段，建议开发一种新的方法，指导更安全的交付疼痛和/或 硬膜外手术（EP）中的麻醉药物。硬膜外注射通常用于治疗 椎间盘突出、椎管狭窄、化学椎间盘、继发于颈椎手术后综合征的慢性疼痛， 和椎间盘源性慢性颈痛。它们也经常用于减轻与分娩有关的疼痛。 然而，如果执行不当，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也可能发生严重的副作用，包括中风， 瘫痪或失明。 提出了一种基于新型光学传感技术的新技术来评估组织成分 并优化施加到针上的力以引导其安全插入硬膜外腔， 提出监测表皮空间中的脉动压力，以评估 药物输送导管。第一阶段的工作重点是开发一个实验室原型， 初步测试和优化离体动物组织标本，然后初步评估其疗效 在猪体内。根据第一阶段的研究结果，该技术将在第二阶段得到进一步改进， 在BWH进行了人体验证。