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4. 发明公开

EP2130558A1 Methods and devices for collecting, handling and processing mammary fluid samples for evaluating breast diseases, including cancer 审中-公开
标题翻译：的方法和装置，用于收集，处理和乳房的流体样品的处理乳腺疾病的评估，包括癌症
公开(公告)号：EP2130558A1
公开(公告)日：2009-12-09
申请号：EP09170064.1
申请日：2001-11-13
申请人： Ensisheim Partners LLC
发明人： Quay, Steven C.
IPC分类号： A61M1/06 , A61B5/00 , C12Q1/68 , G01N33/574 , A61B10/00
CPC分类号： C12Q1/6886 , A61B5/14546 , A61B10/0041 , A61B10/0045 , A61B10/0096 , A61M1/06 , A61M1/064 , A61M1/066 , A61M2205/075
摘要： Non-invasive methods are provided for obtained biological samples of mammary fluid or mammary fluid components from a patient using a breast pump device (10) incorporating or coupled with a solid phase sample collection medium (38). Use of the breast pump device stimulates expression of mammary fluid from patients, which provides for collection of diagnostic samples to evaluate breast disease, including cancer, in the patient. Methods for using the device optionally incorporate induction of mammary fluid expression by administration of oxytocin analog to the patient to stimulate myoepithelial contraction of the mammary alveolar glands. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components obtained according to the above sample collection methods. Also provided within the invention are novel breast pump and breast pump adapter devices that incorporate a solid phase sample collection medium integrated within the breast pump or adapter or otherwise fluidly connected therewith. These devices collect a sample of expressed breast fluid by contacting the fluid with a solid phase sample collection medium while the pump or adapter is applied to the breast. Yet additional methods, devices accessories, and material are provided for laboratory handling and processing of breast fluid samples and diagnostic methods related thereto. Among these are specially adapted fluid retaining reservoirs (30) for use within a breast fluid collection pump of the invention which are useful within a variety of mammary fluid collection, sample handling and sample processing methods.
摘要翻译：提供了用于从患者使用吸奶器装置（10）包含或耦合与固相样品收集介质（38）乳房液或乳腺流体组分的获得的生物样品的非侵入性方法。吸奶器装置的用途刺激患者乳房液，这对于诊断样品收集提供了评估乳腺疾病，包括癌症病人的表达。方法和使用乳房液表达的设备可选地伴侣诱导催产素类似物的给予患者以刺激乳腺肺泡腺体肌上皮收缩。过程中或乳腺流体表达后，生物样品被收集在整个乳房液，全细胞或细胞组分，其它选择的液体或乳腺流体的固体级分，纯化或散装蛋白质，糖蛋白，肽，核苷酸或其他所期望的形式乳房液的成分。因此，提供方法和试剂盒用于确定性采矿乳房疾病标志物的存在或量而获得gemäß上述样品采集方法乳腺流体或乳腺流体组分的生物样品英寸因此本发明提供了内是新颖的吸奶器乳房和泵适配器设备确实结合了吸奶器或适配器或以其他方式流体地具有连接有内集成的固相样品收集平台。这些装置收集通过接触与固相样品收集介质中的流体在泵或适配器被施加到乳房中过表达乳房流体的样品。然而附加的方法，设备附件和材料提供了用于实验室处理和乳房的流体样品的处理和与其相关的诊断方法。间论文专门适用流体保持贮存器（30），用于本发明的吸奶器的流体收集中使用哪些是多种乳房液收集，样品处理和样品处理方法中是有用的。

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