Implantable Microdevice for the Treatment of Hydrocephalus

用于治疗脑积水的植入式微型装置

• 批准号: 7911975
• 负责人: HONGSEOK M NOH
• 金额: $ 8万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7911975
• 关键词: Address; Adhesions; Admission activity; Adult; Animal Model; Arachnoid mater; Biological; Blood Clot; Blood Platelets; Blood coagulation; Body part; Brain; Cephalic; Cerebrospinal Fluid; Cessation of life; Characteristics; Childhood; Communicating Hydrocephalus; Creation of ventriculo-peritoneal shunt; Devices; Drainage procedure; Dura Mater; Environment; Equilibrium; Failure; Goals; Growth; Histologic; Hospitals; Human; Hydrocephalus; Implant; In Vitro; Infection; Lead; Liquid substance; Location; Maintenance; Membrane; Microfabrication; Miniature Swine; Movement; Newly Diagnosed; Operative Surgical Procedures; Pathologic; Patients; Performance; Peritoneum; Physiological; Polymers; Population; Puncture procedure; Research; Research Project Grants; Sagittal Sinus; Shunt Device; Simulate; Sinus; Spinal Cord; Sterilization for infection control; Subarachnoid Space; Superior sagittal sinus; System; Techniques; Technology; Testing; Tissues; Translating; Tube; United States; Ventricular; Water; absorption; biomaterial compatibility; cerebrospinal fluid flow; cost; design; disability; implantable device; implantation; innovation; neurosurgery; pressure; prevent; prototype; public health relevance; response; simulation; venous sinus

DESCRIPTION (provided by applicant): The brain and spinal cord are protected by a fluid called cerebrospinal fluid (CSF). CSF is produced in the brain, circulates throughout the subarchnoid space around the brain and spinal cord, and is absorbed into the sagittal sinus through a thin membrane (dura mater) that contains biological valves called arachnoid granulations (AG). When the AGs do not function properly this dynamic equilibrium is altered and the pathologic condition of hydrocephalus ensues. Hydrocephalus is an abnormal accumulation of CSF within the subarachnoid space of the brain due to impaired CSF absorption. Hydrocephalus is one of the most frequently encountered problems in Neurosurgery. 8,305 newly diagnosed cases of hydrocephalus were treated in the year 2000 and the overall cost was approximately $1.1 billion in the United States alone. The current treatment of hydrocephalus consists of implanting a shunt device that diverts the CSF from the brain into another part of the body such as the peritoneum. The shunt device consists of a one-way valve and two long tubes connected to the ventricular space and the drainage space, respectively. The treatment which was developed in the 1950's has remained essentially unchanged for over 50 years. Ventriculo-peritoneal (VP) shunts are the most common type of shunt in use but have significant shortcomings such as high failure rate (~ 50% within 2 years) and imprecise flow control resulting in under- or over-shunting. We propose an innovative approach for the treatment of hydrocephalus. The goal of our research is to develop an implantable microdevice analogous to the native biological valve that diverts excessive CSF from the subarachnoid space to the sagittal sinus. We are attempting to replace the malfunctioning arachnoid granulations that cause hydrocephalus with a miniature artificial device to restore the normal absorptive function. The proposed microfabricated arachnoid granulations (MAG) consist of an array of hollow microneedles and corresponding one-way microvalves. The microneedle array will be surgically placed to pierce the dura mater to act as a one-way outlet for CSF from the subarachnoid space to the venous sinus. Microvalves within the microneedles act as passive valves that regulate the flow of CSF to the sagittal sinus. The flow of CSF will be in response to the pressure differential between the sagittal sinus and the subarachnoid space just as in normally functioning AG. In order to achieve the goal, three specific aims are proposed: 1) Design, simulate, and fabricate MAGs capable of diverting CSF equivalent to normally functioning AG, 2) Test the MAGs in vitro using a bench-top CSF simulator, 3) Demonstrate surgical implantation and short-term functioning of the MAG using an animal model. If successful, the proposed MAG will pioneer a new era in the treatment of hydrocephalus. PUBLIC HEALTH RELEVANCE: This research project will develop an innovative implantable device for the treatment of hydrocephalus which is one of the most frequently encountered problems in Neurosurgery. An implantable microdevice that resembles the function of the native arachnoid granulations which acts as biological valves to eliminate cerebrospinal fluid will be developed using microfabrication technology. The proposed microfabricated arachnoid granulations (MAG) will make it possible to replace the malfunctioning arachnoid granulations that lead to hydrocephalus. If successful, the proposed MAG may pioneer a new era in the treatment of hydrocephalus.

描述（由申请人提供）：大脑和脊髓受到一种称为脑脊液（CSF）的液体的保护。脑脊液在大脑中产生，在大脑和脊髓周围的蛛网膜下腔中循环，并通过含有称为蛛网膜颗粒 (AG) 的生物瓣膜的薄膜（硬脑膜）吸收到矢状窦中。当 AG 不能正常发挥作用时，这种动态平衡就会改变，脑积水的病理状况就会随之发生。脑积水是由于脑脊液吸收受损而导致脑脊液在大脑蛛网膜下腔内异常积聚。脑积水是神经外科最常见的问题之一。 2000 年，新诊断的脑积水病例有 8,305 例接受治疗，仅在美国，总费用就约为 11 亿美元。目前脑积水的治疗包括植入分流装置，将脑脊液从大脑转移到身体的另一部分，例如腹膜。分流装置由一个单向阀和两根分别连接至心室空间和引流空间的长管组成。 20世纪50年代开发的治疗方法50多年来基本没有变化。脑室腹膜 (VP) 分流术是最常见的分流类型，但具有显着的缺点，例如失败率高（2 年内约 50%）和不精确的流量控制导致分流不足或过度。我们提出了一种治疗脑积水的创新方法。我们研究的目标是开发一种类似于天然生物瓣膜的植入式微型装置，将过量的脑脊液从蛛网膜下腔转移到矢状窦。我们正在尝试用微型人工装置替换导致脑积水的故障蛛网膜颗粒，以恢复正常的吸收功能。所提出的微制造蛛网膜颗粒（MAG）由一系列空心微针和相应的单向微阀组成。微针阵列将通过手术放置刺穿硬脑膜，作为脑脊液从蛛网膜下腔到静脉窦的单向出口。微针内的微阀充当被动阀，调节脑脊液流向矢状窦。脑脊液的流动将响应矢状窦和蛛网膜下腔之间的压力差，就像正常功能的 AG 一样。为了实现这一目标，提出了三个具体目标：1) 设计、模拟和制造能够转移 CSF 的 MAG，相当于正常功能的 AG，2) 使用台式 CSF 模拟器在体外测试 MAG，3) 演示使用动物模型进行 MAG 的手术植入和短期功能。如果成功，拟议的 MAG 将开创脑积水治疗的新时代。 公共健康相关性：该研究项目将开发一种创新的植入式装置，用于治疗脑积水，脑积水是神经外科最常见的问题之一。将利用微加工技术开发一种可植入的微型装置，其功能类似于天然蛛网膜颗粒，充当消除脑脊液的生物瓣膜。所提出的微制造蛛网膜颗粒（MAG）将有可能取代导致脑积水的故障蛛网膜颗粒。如果成功，所提出的 MAG 可能会开创脑积水治疗的新时代。

项目成果

A novel microneedle array for the treatment of hydrocephalus.

• DOI: 10.1007/s00542-013-1988-4
• 发表时间: 2014-06-01
• 期刊: MICROSYSTEM TECHNOLOGIES-MICRO-AND NANOSYSTEMS-INFORMATION STORAGE AND PROCESSING SYSTEMS
• 影响因子: 2.1
• 作者: Oh, Jonghyun;Liu, Kewei;Medina, Tim;Kralick, Francis;Noh, Hongseok (Moses)
• 通讯作者: Noh, Hongseok (Moses)