Microfluidic neutrophil counter for at-home use by chemotherapy patients

供化疗患者在家使用的微流控中性粒细胞计数器

• 批准号: 8523488
• 负责人: Sung Hwan Cho
• 金额: $ 34.74万
• 依托单位: NANOCELLECT BIOMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8523488
• 关键词: Accident and Emergency department; Accounting; Address; Adverse effects; Algorithms; Blood; Blood Cells; Blood Glucose; Blood Tests; Blood specimen; Cancer Patient; Cell Size; Cell Volumes; Cells; Cessation of life; Classification; Code; Communities; Complete Blood Count; Computer software; Data Analyses; Development; Devices; Equilibrium; Erythrocytes; Event; Flow Cytometry; Glass; Goals; Health Care Costs; Healthcare; Healthcare Systems; Home environment; Hospitals; Individual; Infection; Instruction; Knowledge; Leukocytes; Life; Liquid substance; Masks; Medical; Methods; Microfluidic Microchips; Microfluidics; Mission; Monitor; Neutropenia; Nosocomial Infections; Optics; Outcome; Outpatients; Pain; Patients; Pattern; Performance; Persons; Phase; Physicians' Offices; Population; Positioning Attribute; Preparation; Procedures; Process; Property; Publications; Quality of life; Risk; Sampling; Self-Administered; Signal Transduction; Slide; Speed; System; Techniques; Technology; Test Result; Testing; Time; Training; Travel; Visit; base; cell behavior; chemotherapy; commercialization; computerized data processing; cost; design; graphical user interface; improved; innovation; innovative technologies; instrument; interest; medical attention; minimally invasive; neutrophil; novel; oncology; operation; patient home care; point of care; portability; prototype; public health relevance; residence; simulation; user-friendly

DESCRIPTION (provided by applicant): This proposal describes a novel method for rapidly counting neutrophils in a patient's blood sample. Neutropenia, characterized by an abnormally low number of neutrophils that serve as the primary defense against infections, is a common side effect of chemotherapy. Without prompt medical attention, the condition of neutropenia may become life threatening. Since the majority of oncology patients (about 1 million each year in the US) are treated on an outpatient basis, the number of neutrophils must be closely and frequently monitored to allow timely treatment in the event of neutropenia and associated infections. Furthermore, patients undergoing antiproliferative chemotherapy with neutropenia are particularly sensitive to nosocomial (hospital) infections, causing 99,000 deaths each year. Therefore, in consideration of the interest of cancer patients, as well as the cost and efficiency of our healthcare system, the ability for self-administered neutrophil test at the patient's residence is particularly important and attractive. Today's complete blood count devices have been designed for central medical facilities. They are very expensive and too complicated to operate by patients. Even the simper blood test devices for point-of-care applications are designed for use in physician's office and unsuitable for patient-administered testing at home. To address this important unmet need, we propose a unique and innovative device for patient-administered neutrophil testing at home. Our neutrophil counting device takes advantage of cellular properties manifested specifically when flowing through microfluidic channels. Supported by recent publications, the combined information of cell size and deformability can determine the equilibrium positions of flowing cells in a microfluidic channel due to fundamental fluidic dynamic properties. We invented a space-time coding technique to encode the forward scattering signal of each travelling cell. By decoding the signal, we obtain the velocity and position of each individual cell with a very high accuracy (0.1 um). Since the cell position within a microfluidic channel is directly related to the cell volume and deformability, we have found an innovative method to classify white blood cells, particularly neutrophils. Our device and analysis method possesses the following salient features: (1) it is minimally invasive, requiring only 5 microliters of blood (a similar amount to a typical blood glucose test); (2) straightforward sample preparation and test procedures that can be performed by persons without medical training; (3) accurate test results that are easy to understand and compliant to medical standards; (4) low cost; and (5) high portability. We therefore envision that the successful development and commercialization of the device will bring tremendous benefits to cancer patients because the device can greatly reduce the risk of hospital infection, cut down healthcare costs, improve outcomes during chemotherapy due to close monitoring of neutropenia, and minimize the inconvenience and pain for unnecessary hospital and emergency room visits.

描述（由申请人提供）：该提案描述了一种新的方法，用于快速计数患者的血液样本中嗜中性粒细胞。中性粒细胞减少症的特征是异常数量的中性粒细胞作为针对感染的主要防御，是化学疗法的常见副作用。没有迅速的医疗护理，中性粒细胞减少症的状况可能会威胁生命。由于大多数肿瘤患者（在美国每年约100万）接受门诊治疗，因此中性粒细胞的数量必须密切和经常监测，以便在中性粒细胞减少症和相关感染时及时治疗。此外，接受抗增生性化疗的中性粒细胞减少疗法的患者对医院（医院）感染特别敏感，每年导致99,000例死亡。因此，考虑到癌症患者的兴趣以及我们的医疗保健系统的成本和效率，在患者住所中自我管理中性粒细胞测试的能力特别重要且有吸引力。当今的完整血液计数设备是为中央医疗设施设计的。它们非常昂贵，太复杂了，无法由患者操作。即使是用于护理点应用的Simper血液测试设备，也设计用于医师办公室，不适合在家中进行患者管理的测试。为了满足这一重要的未满足需求，我们提出了一种独特而创新的装置，用于在家中进行患者的嗜中性粒细胞测试。我们的中性粒细胞计数装置利用了流经微流体通道时专门表现出的细胞性质。在最近出版物的支持下，由于基本流体动力学特性，细胞大小和可变形性的组合信息可以确定微流体通道中流动细胞的平衡位置。我们发明了一种时空编码技术来编码每个行进单元的正向散射信号。通过解码信号，我们以非常高的精度（0.1 um）获得每个单个单元的速度和位置。由于细胞位置 微流体通道与细胞体积和可变形性直接相关，我们发现了一种创新的方法来对白细胞，尤其是中性粒细胞进行分类。我们的设备和分析方法具有以下显着特征：（1）它的侵入性最低，只需要5微光的血液（与典型的血糖测试相似）； （2）直接样本 可以由未经医学培训的人执行的准备和测试程序； （3）易于理解且符合医学标准的准确测试结果； （4）低成本； （5）高便携性。因此，我们设想，该设备的成功开发和商业化将为癌症患者带来巨大的好处，因为该设备可以大大降低医院感染的风险，降低医疗保健成本，改善因中性粒细胞减少的监测而在化学疗法期间改善结果，并最大程度地减少不便和不必要的医院和急诊房间的疼痛。