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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要 Physical Sciences Inc. (PSI) 与 Beth Israel Deaconess (BID) 的麻醉师合作 Hospital 和布莱根妇女医院 (BWH) 将担任 I 期和临床的顾问第二阶段的研究人员建议开发一种新方法来指导更安全地传递疼痛和/或硬膜外手术 (EP) 期间的麻醉药物通常用于治疗疼痛。椎间盘突出、椎管狭窄、化学椎间盘、宫颈手术后综合症继发的慢性疼痛、它们也经常用于缓解与分娩相关的疼痛。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，包括中风、瘫痪或视力丧失。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在针上的力，以引导其安全插入硬膜外腔，同时建议监测表皮空间中的脉动压力以评估适当的定位第一阶段的工作重点是开发一个实验室原型。初步在动物组织标本上进行离体测试和优化，然后初步评估其功效基于第一阶段的研究结果，该技术将在第二阶段和第二阶段进一步改进。 BWH 在人体上进行了验证。